[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Allist Pharmaceuticals, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":223},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,42,68,91,112,137,160,182,201],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100516727","phase-2-a-phase-ii-study-evaluating-jab-21822-monotherapy-in-adult-patients-with-pancreatic-cancer-and-other-solid-tumors-harboring-the-kras-pg12c-mutation-100516727",false,"NCT06008288","A Phase II Study Evaluating JAB-21822 Monotherapy in Adult Patients With Pancreatic Cancer and Other Solid Tumors Harboring the KRAS p.G12C Mutation.","A Single-arm, Multicenter, Open-label Phase II Clinical Study Evaluating the Efficacy and Safety of JAB-21822 Monotherapy in Patients With Locally Advanced or Metastatic Pancreatic Cancer and Other Solid Tumors Harboring the KRAS p.G12C Mutation.","Inclusion Criteria:\n\n* Patients with the KRAS p.G12C mutation confirmed through testing using prospectively validated companion diagnostic reagents or clinical trial assay (CTA) methods.\n* Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors (excluding NSCLC and CRC).\n* Patients with pancreatic cancer must have progressed or been intolerant to prior gemcitabine-based chemotherapy regimens or FOLFIRINOX\u002FmFOLFIRINOX\u002FNALIRIFOX treatment. Patients with other types of solid tumors must have progressed or been intolerant to prior systemic therapies and lack satisfactory alternative treatment options.\n\nExclusion Criteria:\n\n* Previously received a KRAS G12C inhibitor.\n* History of interstitial lung disease, non-infectious pneumonia, or uncontrolled lung disease (including pulmonary fibrosis, acute lung disease, etc.) with clinical symptoms.\n* Uncontrolled pleural effusion, pericardial effusion, or ascites.\n* Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 electrocardiograms.\n* Use of a drug with known risk of torsades de points (TdP) within 14 days prior to the first dose.","ALL","18 Years",{"count":19,"type":20},88,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Patients with other advanced solid tumors (excluding NSCLC and CRC) who have progressed after prior systemic therapy or are intolerant and lack satisfactory alternative treatment options, aiming to evaluate the efficacy and safety of Glecirasib in these patients.",[26,27,28],"KRAS P.G12C","Pancreatic Cancer","Solid Tumor","RECRUITING","2026-03-11",{"date":32,"type":33},"2026-03-13","ACTUAL",{"date":35,"type":33},"2023-10-27",{"date":37,"type":20},"2027-12-31",{"name":39,"class":40},"Allist Pharmaceuticals, Inc.","INDUSTRY",31,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100589559","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-efficacy-of-ast2303-tablets-abk3376-tablets-in-patients-with-advanced-or-metastatic-non-small-cell-lung-cancer-100589559","NCT06955988","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AST2303 Tablets (ABK3376 Tablets) in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AST2303 Tablets (ABK3376 Tablets) in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Have fully understood this test and voluntarily sign the informed consent\n2. Age ≥ 18 at the time of signing the informed consent, regardless of gender\n3. Patients with non-small cell lung cancer confirmed by tissue \u002F cytology.\n4. According to recist1.1 criteria, the presence of at least one target lesion without local treatment was assessed by the investigator\n5. Agree to provide blood samples and \u002F or tumor tissue samples (fresh tissue or paraffin embedded tissue) for genetic testing\n6. The subject's bone marrow and organ functions are good (no blood transfusion or hematopoietic growth factor treatment within 2 weeks before the first administration)\n7. The ECoG physical status score is 0 or 1\n8. Expected survival time ≥ 12 weeks\n9. Have normal swallowing function\n10. Female subjects with fertility must have a serum pregnancy test within 7 days before the first administration, and the result is negative, and must be non lactating. For female subjects with fertility and male subjects with reproductive potential, effective contraceptive measures were taken from the signing of informed consent to 6 months after the last Administration\n\nExclusion Criteria:\n\n1. Previously received antitumor therapy targeting the c797s mutation\n2. Carry any other known driver gene alterations\n3. Have received any systemic anti-tumor treatment (including anti-tumor drugs in clinical research stage) within 2 weeks before the first administration or within 5 half lives of the drug (whichever is longer); Or receiving anti-tumor drugs with long half-life, such as immune checkpoint inhibitors, within 4 weeks before the first administration; Or received cytotoxic drugs with significant delayed toxicity, such as mitomycin C, within 6 weeks before the first administration;\n4. Have received non-specific immunomodulatory agents, traditional Chinese medicine or traditional Chinese medicine preparations with approved anti-tumor indications within 2 weeks before the first administration\n5. Strong inhibitors of CYP3A, P-gp or BCRP were used within 7 days before the first administration, or strong inducers of CYP3A, P-gp or BCRP were used within 3 weeks\n6. Local (non bone lesions) radiotherapy within 4 weeks before the first dose, or bone radiotherapy within 2 weeks before the first dose;\n7. Other malignant tumors besides the primary tumor\n8. Subjects known to have meningeal metastasis, brainstem metastasis, spinal cord metastasis and \u002F or compression, active brain metastasis. For brain metastasis subjects who have received local treatment in the past, if they are clinically stable for at least 4 weeks before the first administration of study treatment and do not need to use glucocorticoids or anticonvulsants for at least 14 days before the first administration of study treatment, they can participate in the study\n9. The tumor invades the surrounding important organs and blood vessels or has the risk of esophago tracheal fistula or esophago pleural fistula\n10. The toxicity of previous anti-tumor treatment has not returned to grade ≤ 1 (NCI CTCAE version 5.0 evaluation), except for grade ≤ 2 alopecia and peripheral neuropathy\n11. Presence of cardiovascular and cerebrovascular disease or cardiovascular and cerebrovascular risk factors\n12. Uncontrollable systemic diseases\n13. There is a history of (non infectious) interstitial lung disease (ILD) or non infectious pneumonia requiring steroid treatment; Currently have ILD or non infectious pneumonia; Suspected ILD or noninfectious pneumonia that could not be excluded by imaging examination was present at screening\n14. Pulmonary complications lead to clinically serious lung damage, including but not limited to the following: A. any underlying lung disease; b. Any autoimmune, connective tissue or inflammatory disease that may involve the lungs; c. Previous unilateral pneumonectomy\n15. Severe acute or chronic infection\n16. Being under long-term systemic corticosteroid treatment with prednisone \\> 10 mg\u002F day or equivalent anti-inflammatory active drugs or any form of immunosuppressive treatment before the first administration. Subjects who need to use bronchodilators, inhaled or topical steroids or local steroid injections for treatment or as preventive medication for hypersensitivity reactions (such as medication before CT examination, etc.) can be included in the study\n17. Subjects who had undergone major surgery within 4 weeks before the first dose or were expected to undergo major surgery during the study period\n18. Bleeding symptoms with significant clinical significance or obvious bleeding tendency within 4 weeks before the first administration, such as gastrointestinal bleeding, gastric ulcer bleeding, active hemoptysis, etc\n19. It is known that there are serious gastrointestinal dysfunction: such as untreated recurrent diarrhea, moderate to severe atrophic gastritis, gastrointestinal obstruction, Crohn's disease, ulcerative colitis, gastrointestinal perforation, etc\n20. Known to have a history of hypersensitivity to the ingredients of the preparation used in the test\n21. Pregnant or lactating women or women planning to become pregnant during the study\n22. In the judgment of the investigator, the subject has other factors that may affect the results of the study or cause the forced termination of the study, such as alcohol abuse, drug abuse, suffering from other serious diseases (including mental diseases) requiring combined treatment, serious abnormal laboratory test values, family or social factors and other conditions that may affect the safety of the subject or the collection of test data, etc",{"count":50,"type":20},120,[52],"PHASE1","This study is a multicenter, single arm, open label, phase I clinical trial, including dose escalation (phase IA) and dose expansion (phase IB). This study aimed to evaluate the safety, tolerability, PK characteristics and preliminary antitumor activity of ast2303 tablets (abk3376 tablets) in subjects with locally advanced or metastatic non-small cell lung cancer. A safety review committee (SRC) was established in this study, which will review the safety, efficacy, pharmacokinetics and other data obtained from the study, and make decisions on key issues such as dose escalation and dose expansion.",[55],"Locally Advanced or Metastatic Non-small Cell Lung Cancer",[57,58],"EGFR L858R-C797S","Del19-C797S","2026-02-10",{"date":61,"type":33},"2026-02-12",{"date":63,"type":33},"2025-03-04",{"date":65,"type":20},"2027-06",{"name":39,"class":40},1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":67},"100590685","phase-3-a-study-evaluating-furmonertinib-plus-platinum-based-doublet-chemotherapy-versus-osimertinib-in-patients-with-epidermal-growth-factor-receptor-egfr-sensitizing-mutation-positive-non-squamous-non-small-cell-lung-cancer-nsclc-and-brain-metastases-100590685","NCT06970639","A Study Evaluating Furmonertinib Plus Platinum-based Doublet Chemotherapy Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Sensitizing Mutation-Positive Non-squamous Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases","A Phase III, International, Multicenter, Randomized, Controlled, Open-label Clinical Study Evaluating Furmonertinib Plus Platinum-based Doublet Chemotherapy Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Sensitizing Mutation-Positive Non-squamous Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases","Inclusion Criteria:\n\n1. Fully understand the trial and voluntarily sign the informed consent form;\n2. Age ≥18 years at the time of signing ICF, regardless of gender;\n3. Histologically\u002Fcytologically confirmed non-squamous NSCLC with brain parenchymal metastases assessed by BICR; Subjects with both brain parenchymal and leptomeningeal metastases are eligible. Subjects without brain metastases may be enrolled in the safety run-in phase.\n4. For subjects with brain metastases: clinically stable for ≥4 weeks prior to first dose AND no requirement for corticosteroids\u002Fanticonvulsants for ≥14 days prior to first dose; Investigator-confirmed no need for local therapy for brain metastases during screening.\n5. Confirmed EGFR sensitizing mutations (ex19del or L858R) via tumor tissue\u002Fcytology\u002Fblood testing;\n6. No prior systemic anti-tumor therapy for advanced\u002Fmetastatic NSCLC; Subjects who received (neo)adjuvant chemotherapy or definitive chemoradiotherapy must have disease recurrence\u002Fprogression ≥6 months after completion;\n7. ≥1 measurable intracranial AND extracranial lesion(s) per RECIST v1.1 without prior local treatment;\n8. ECOG PS 0-1 with no deterioration within 2 weeks prior to first dose, and life expectancy ≥3 months;\n9. Adequate bone marrow and organ function (no transfusion\u002FG-CSF within 2 weeks prior to first dose);\n10. All prior treatment-related toxicities resolved to ≤Grade 1 (per NCI CTCAE v5.0) except alopecia (≤Grade 2) or peripheral neuropathy (≤Grade 2);\n11. Women of childbearing potential (WOCBP) must have negative serum pregnancy test within 7 days prior to first dose, be non-lactating, and use effective contraception from ICF signing until 6 months after last dose. Male subjects with fertile partners must use contraception during the same period.\n\nExclusion Criteria:\n\n1. The tumor histology or cytology confirmed that the combination of neuroendocrine carcinoma, sarcomatoid carcinoma or squamous cell carcinoma was more than 10%;\n2. Known subjects with ALK positive, ros1 positive, RET fusion positive, ntrk fusion positive, BRAF V600 mutation, met exon 14 skipping variant and other approved drugs for this target;\n3. Subjects with meningeal metastasis but no brain parenchymal metastasis confirmed by MRI and \u002F or CSF malignant cell examination;\n4. Subjects who have previously received any of the following treatments:\n\n   1. Have received any systemic anti-tumor therapy targeting EGFR in the past, including those in clinical research stage (including EGFR TKI, monoclonal antibody, bispecific antibody, etc.);\n   2. Previously received systemic antitumor therapy (such as chemotherapy, targeted therapy, immunotherapy, etc.) for locally advanced \u002F metastatic non-small cell lung cancer;\n   3. Received \\> 30 Gy of chest radiotherapy within 6 months before the first dose; Received non thoracic radiotherapy of \\>30 Gy within 4 weeks before the first dose; Received palliative radiotherapy ≤ 30Gy within 2 weeks before the first dose; Previous brain radiotherapy;\n5. Chinese patent medicine that has received non-specific immune modulators (including but not limited to interferon and IL-2) and approved anti-tumor indications within 2 weeks before the first administration;\n6. Have used any strong inhibitor of cytochrome P450 3A4 (CYP3A4) within 7 days before the first administration or any strong inducer of CYP3A4 within 21 days before the first administration;\n7. Other malignant tumors in addition to the primary tumor; Skin basal cell or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, breast ductal carcinoma in situ and papillary thyroid cancer that can be treated locally and have been cured can be selected; Subjects with a history of other malignancies and who have been cured for ≥ 3 years after radical treatment can be enrolled;\n8. Brain metastasis subjects with known brain stem metastasis, spinal cord metastasis and \u002F or compression; Subjects with acute or progressive intracranial hypertension related symptoms during the screening period; Subjects with brain herniation or near brain herniation; Brain imaging revealed significant brain midline deviation and other subjects requiring urgent local treatment;\n9. According to CTCAE 5.0, there were subjects with grade 2 headache, vomiting, papilledema, etc. caused by increased intracranial pressure during the screening period; Subjects with grade 2 sensory \u002F motor impairment and visual field damage caused by brain metastasis during the screening period; Subjects with mental symptoms (such as dementia, sluggish reaction, etc.) or seizures caused by brain metastasis during the screening period; Subjects who can control relevant central nervous system symptoms ≤ 1 grade by steroid hormones or anticonvulsants can be enrolled;\n10. The tumor invades the surrounding important organs and blood vessels (such as the heart, esophagus, superior vena cava, etc.) or has the risk of esophago tracheal fistula or esophago pleural fistula;\n11. Cardiovascular and cerebrovascular disease or cardiovascular and cerebrovascular risk factors exist.\n12. There are uncontrollable systemic diseases.\n13. There is a history of (non infectious) interstitial lung disease (ILD) or non infectious pneumonia requiring steroid treatment.\n14. Pulmonary complications lead to clinically severe lung damage.\n15. Severe acute or chronic infection\n16. Subjects who are receiving long-term systemic corticosteroid therapy with prednisone \\> 10 mg\u002Fd or equivalent anti-inflammatory active drugs or any form of immunosuppressive therapy before the first administration \\[subjects who need bronchodilators, inhaled or topical steroids or local steroid injection therapy, or as preventive medication for hypersensitivity reactions (such as medication before CT examination, etc.), or to control central nervous system symptoms in patients with brain metastasis can be included in the study\\];\n17. Subjects who had undergone major surgery within 4 weeks before the first dose or were expected to undergo major surgery during the study;\n18. Bleeding symptoms with significant clinical significance or obvious bleeding tendency within 4 weeks before the first administration.\n19. Severe gastrointestinal dysfunction is known.\n20. Known or suspected allergy to the ingredients of the study drug or its analogues;\n21. Pregnant or lactating women or female subjects who plan to become pregnant during the study or within 6 months after the last dose;\n22. In the judgment of the investigator, the subject has other factors that may affect the results of the study or cause the forced termination of the study, such as alcohol abuse, drug abuse, suffering from other serious diseases (including mental diseases) requiring combined treatment, serious abnormal laboratory test values, family or social factors and other conditions that may affect the safety of the subject or the collection of test data.",{"count":76,"type":20},380,[78],"PHASE3","This study is a Phase III, international, multicenter, randomized, controlled, open-label clinical trial. The primary objective is to evaluate the efficacy and safety of furmonertinib plus platinum-based doublet chemotherapy (Arm A) versus osimertinib monotherapy (Arm B) in patients with EGFR sensitizing mutation-positive non-squamous non-small cell lung cancer (NSCLC) and brain metastases. Additionally, a proportion of subjects will receive furmonertinib monotherapy (Arm C) to further explore its efficacy and safety profile.\n\nStage 1 is the safety run-in phase, planned to enroll approximately 30 subjects who will be randomized at a 1:1 ratio to receive either furmonertinib 80 mg QD plus platinum-based chemotherapy or furmonertinib 160 mg QD plus platinum-based chemotherapy, aiming to evaluate the safety and tolerability of different furmonertinib doses in combination with platinum-based chemotherapy.\n\nStage 2 is the randomized controlled phase, in which approximately 350 subjects will be randomized in a 3:3:1 ratio (Arm A : Arm B : Arm C) to receive the investigational treatments.",[81],"NSCLC Patients With Brain Metastasis",[83,84],"EGFR","firmonertinib",{"date":61,"type":33},{"date":87,"type":33},"2024-09-26",{"date":89,"type":20},"2029-09",{"name":39,"class":40},{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":105,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100589560","phase-3-firmonertinib-versus-platinum-based-chemotherapy-as-first-line-treatment-for-nsclc-with-egfr-pacc-or-egfr-l861q-mutation-100589560","NCT06956001","Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for NSCLC With EGFR PACC or EGFR l861q Mutation","A Phase III, Randomized, Multicentre, Open Label Study to Assess the Efficacy and Safety of Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients With EGFR PACC Mutation or EGFR l861q Mutation","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form (ICF).\n2. Age ≥18 years at the time of ICF signing.\n3. At least one measurable lesion per RECIST v1.1, meeting the following:\n\n   * No prior local therapy (e.g., radiotherapy)\n   * Not used for biopsy during screening\n4. Histologically\u002Fcytologically confirmed non-squamous NSCLC, classified as:\n\n   * Locally advanced (Stage IIIB\u002FIIIC, unsuitable for curative surgery and\u002For definitive chemoradiotherapy)\n   * Metastatic (Stage IV) (Based on UICC\u002FAJCC 8th edition TNM staging)\n5. Agreement to provide:\n\n   * Recent tumor tissue (from untreated lesions)\n   * Blood samples\n   * Central lab-confirmed EGFR PACC or L861Q mutation (If tumor tissue is unavailable due to inaccessible lesions, sponsor consultation is required.)\n6. No prior systemic therapy for advanced\u002Fmetastatic NSCLC.\n\n   * Allowed if: Prior (neo)adjuvant\u002Fdefinitive chemoradiotherapy completed ≥12 months before recurrence\u002Fprogression\n7. ECOG performance status 0-1.\n8. Life expectancy ≥12 weeks.\n9. Adequate bone marrow\u002Forgan function within 14 days before treatment (no transfusion\u002FG-CSF within 2 weeks prior).\n10. Women of childbearing potential (WOCBP):\n\n    * Abstinence or contraception use\n    * No egg donation\n11. Non-sterilized males:\n\n    * Abstinence or contraception use\n    * No sperm donation\n12. CNS metastases allowed if protocol-specified criteria are met.\n\nExclusion Criteria:\n\n1. Histologically\u002Fcytologically confirmed tumor with \\>10% neuroendocrine carcinoma, sarcomatoid carcinoma, or squamous cell components.\n2. Known ALK-positive, ROS1-positive, RET fusion-positive, NTRK fusion-positive, BRAF V600E mutation, MET exon 14 skipping mutation, or other targetable alterations with approved therapies.\n3. Prior treatments including:\n\n   1. Systemic anti-tumor therapy for advanced\u002Fmetastatic NSCLC (e.g., chemotherapy\u002Ftargeted\u002Fimmunotherapy). Neoadjuvant\u002Fadjuvant therapy exceptions per Inclusion Criterion #6.\n   2. \\>30 Gy thoracic radiotherapy within 6 months or non-thoracic radiotherapy within 4 weeks prior to first dose (brain radiotherapy exceptions per Inclusion Criterion #12).\n   3. Any prior EGFR-targeted therapy (including investigational EGFR-TKIs, mAbs, bispecific antibodies, etc.).\n   4. Strong CYP3A4 inhibitors within 7 days or inducers within 21 days prior to first dose.\n   5. Anticancer traditional Chinese medicines within 2 weeks prior to first dose.\n   6. Non-specific immunomodulators (e.g., interferon, IL-2, thymosin) within 2 weeks prior to first dose.\n   7. Major trauma\u002Fsurgery within 4 weeks prior to treatment initiation.\n4. Clinically significant gastrointestinal abnormalities, including:\n\n   * Moderate\u002Fsevere atrophic gastritis\n   * GI obstruction\u002Fperforation\n   * Chronic diarrhea\u002Fshort bowel syndrome\n   * Major upper GI surgery (e.g., gastrectomy)\n   * Inflammatory bowel disease (Crohn's\u002Fulcerative colitis) or active intestinal inflammation\n   * Inability to swallow tablets\n5. Uncontrolled systemic diseases.\n6. Severe acute\u002Fchronic infections.\n7. Interstitial lung disease (ILD)\u002Fnon-infectious pneumonia:\n\n   * History requiring clinical intervention\n   * Current presence\n   * Suspicious imaging findings unresolved at screening\n8. Clinically significant cardiovascular dysfunction (active or history).\n9. Tumor invasion of critical adjacent structures (heart\u002Fesophagus\u002FSVC etc.) with high bleeding\u002Ffistula risk. Exceptions may be considered if investigator assesses minimal risk.\n10. Pulmonary comorbidities causing severe impairment, including:\n\n    1. Baseline lung diseases (e.g., pulmonary embolism \\[≤3 months\\], severe asthma\u002FCOPD\u002Frestrictive disease)\n    2. Autoimmune\u002Fconnective tissue disorders with pulmonary involvement (e.g., rheumatoid arthritis, sarcoidosis)\n11. Residual toxicity \\>Grade 1 (per NCI CTCAE v5.0) from prior anticancer therapy (except alopecia\u002Fneuropathy).\n12. Concurrent malignancies except:\n\n    * Cured localized skin cancers (BCC\u002FSCC), superficial bladder cancer, cervical\u002Fbreast DCIS, or papillary thyroid cancer\n    * Other malignancies cured by radical therapy ≥3 years prior\n13. Pregnancy\u002Flactation or planned pregnancy within 6 months post-treatment.\n14. Inability to comply with study procedures\u002Ffollow-up.\n15. Known hypersensitivity to furmonertinib or excipients.\n16. History of allergic reactions to pemetrexed\u002Fcisplatin\u002Fcarboplatin.\n17. Other exclusionary per investigator judgment, including:\n\n    * Alcohol\u002Fdrug abuse\n    * Severe comorbidities (including psychiatric) requiring treatment\n    * Critical laboratory abnormalities\n    * Social\u002Ffamilial factors compromising safety\u002Fdata collection",{"count":99,"type":20},300,[78],"This study is a randomized, open, multicenter phase III clinical study, which aims to evaluate the efficacy and safety of firmonertinib mesylate compared with platinum based chemotherapy for patients with locally advanced or metastatic NSCLC who have not been treated with systemic antitumor therapy and carry EGFR PaCC mutation or EGFR l861q mutation.\n\nEligible patients were stratified by EGFR mutation type and CNS metastasis at the time of enrollment. Approximately 300 patients would be randomly assigned 1:1 to receive either firmonertinib mesylate (240mg, orally on an empty stomach daily) or platinum containing dual agent chemotherapy.",[83,103],"NSCLC (Advanced Non-small Cell Lung Cancer)",[84],{"date":61,"type":33},{"date":107,"type":33},"2024-11-19",{"date":109,"type":20},"2028-07",{"name":39,"class":40},2,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":21,"phases":122,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":111},"100593744","phase-3-a-study-to-assess-the-efficacy-and-safety-of-firmonertinib-versus-placebo-for-adjuvant-treatment-in-participants-with-stage-ib---iiib-nsclc-with-uncommon-epidermal-growth-factor-receptor-egfr-mutations-following-complete-surgical-resection-with-or-without-adjuvant-chemotherapyfirmost-100593744","NCT07010419","A Study to Assess the Efficacy and Safety of Firmonertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB - IIIB NSCLC With Uncommon Epidermal Growth Factor Receptor (EGFR) Mutations, Following Complete Surgical Resection With or Without Adjuvant Chemotherapy（FIRMOST）","A Global Phase 3, Double-Blind, Randomized, Controlled Multicenter Study to Assess the Efficacy and Safety of Firmonertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB - IIIB NSCLC With Uncommon Epidermal Growth Factor Receptor (EGFR) Mutations, Following Complete Surgical Resection With or Without Adjuvant Chemotherapy (FIRMOST)","FIRMOST","Inclusion Criteria:\n\n1. Sign the Informed Consent Form (ICF).\n2. Aged ≥ 18 years old. Participants from Japan\u002FTaiwan aged ≥ 20 years old.\n3. Histologically confirmed diagnosis of primary non-small cell lung cancer (NSCLC) of predominantly non-squamous histology.\n4. Underwent complete surgical resection of primary lung cancer and systematic lymph node dissection (R0 resection).\n5. Classified post-operatively as Stage IB, II, IIIA, or IIIB (T3N2M0 only) on the basis of pathologic criteria, with the disease staging following the 9th Edition TNM Staging Classification: Lung Cancer issued by Union for International Cancer Control (UICC) and American Joint Committee on Cancer (AJCC).\n6. Documented results of the presence of uncommon EGFR mutations (exon 20 insertion mutations, PACC mutations, and\u002For classical-like mutations, either as single mutations or as co-mutations), in tumor tissue or blood via a validated NGS or validated PCR assay.\n\nExclusion Criteria:\n\nA participant would be excluded from the study if he\u002Fshe meets any of the following:\n\n1. NSCLC with EGFR Exon 19 deletion or L858R or C797S mutation.\n2. Incomplete resection (R1\u002FR2) or segmentectomy or wedge resection only.\n3. Prior treatment with any of the following:\n\n   1. Prior treatment with any antineoplastic therapy other than standard platinum-based doublet adjuvant chemotherapy.\n   2. prior treatment with neoadjuvant therapy.\n4. Concurrent malignant tumors other than the primary tumor; participants with cancers that can be treated locally and cured may be eligible.\n5. Previous ILD (including drug-induced ILD) or active ILD\u002Factive radiation pneumonitis.",{"count":121,"type":20},338,[78],"This is a Phase 3, global, double-blind, randomized, controlled multicenter clinical study to assess the efficacy and safety of adjuvant treatment with firmonertinib versus placebo in participants with Stage IB-IIIB NSCLC with uncommon EGFR mutations (exon 20 insertions, PACC and classical-like mutations) after complete surgical resection with or without adjuvant chemotherapy.\n\nAbout 338 eligible participants will be enrolled and randomized in a 1:1 ratio to receive either firmonertinib 240 mg QD or placebo QD in 21-day treatment cycles. Before randomization, the participant must have undergone complete surgical resection (R0 resection), must have sufficiently recovered from surgery, and must have completed adjuvant chemotherapy (if applicable). The participants will receive firmonertinib or placebo as adjuvant treatment until unacceptable toxicity, withdrawal of informed consent, disease recurrence, initiation of new antitumor treatment, completion of treatment, or other end of treatment reason is met.",[125,126],"NSCLC","Adjuvant Treatment",[83,125,128],"Firmonertinib","2025-06-05",{"date":131,"type":33},"2025-06-08",{"date":133,"type":33},"2025-05-28",{"date":135,"type":20},"2032-04-30",{"name":39,"class":40},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":21,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},"100548086","phase-3-jab-21822-combined-with-jab-3312-compared-soc-in-the-first-line-for-treatment-of-advanced-non-small-cell-lung-cancer-with-kras-pg12c-mutation-100548086","NCT06416410","JAB-21822 Combined With JAB-3312 Compared SOC in the First Line for Treatment of Advanced Non-small Cell Lung Cancer With KRAS p.G12C Mutation","An Open-label, Randomized, Positive Control, Multicenter Phase III Clinical Study. Evaluating JAB-21822 Combined With JAB-3312 Compared Tislelizumab Combined With Pemetrexed + Carboplatin in the First Line for Treatment of Advanced Non-squamous Non-small Cell Lung Cancer With KRAS p.G12C Mutation","Inclusion Criteria:\n\n* A signed written informed consent is required before performing any study-related operations\n* Age greater than or equal to 18 years old\n* Histologically or cytologically confirmed locally advanced\u002Fmetastatic, unresectable non-squamous NSCLC with KRAS p. G12C mutation confirmed by the central lab\n* No history of systemic anticancer therapy to the local advanced\u002Fmetastatic disease\n* Expected survival period greater than or equal to 3 months\n* Having at least one target lesion according to RECIST 1.1\n* Eastern Cooperative Oncology Group (ECOG) ≤ 1\n\nExclusion Criteria:\n\n* Previous (≤2 years) or current solid tumors or hematologic tumors of other pathological types\n* Carry other driver gene mutations with available target therapy, or carry other KRAS mutations\n* Subjects with untreated central nervous system (CNS) metastases were excluded;\n* Uncontrolled pleural effusion, pericardial effusion, and ascites\n* Subjects with impaired heart function or clinically significant heart disease",{"count":145,"type":20},392,[78],"This Phase 3 study will evaluate the efficacy of JAB-21822+JAB-3312 versus tislelizumab (PD-1 Ab) combined with pemetrexed+carboplatin as the first line treatment in subjects with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).",[149,150],"Advanced Non-squamous Non-small-cell Lung Cancer","Metastatic Non-squamous Non Small Cell Lung Cancer","2025-04-03",{"date":153,"type":33},"2025-04-04",{"date":155,"type":33},"2024-08-07",{"date":157,"type":20},"2027-02-28",{"name":39,"class":40},37,{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":21,"phases":169,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":175,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},"100461404","phase-1-phase-12a-study-of-jab-21822-plus-jab-3312-in-patients-with-advanced-solid-tumors-harboring-kras-pg12c-mutation-100461404","NCT05288205","Phase 1\u002F2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation","A Phase 1\u002F2a Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of JAB-21822 in Combination With JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation","Inclusion Criteria:\n\n* A written informed consent should be signed by a subject or his\u002Fher legal representative before any study-related procedures are performed;\n* Subjects with histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors harboring KRAS p.G12C mutation who have failed or lack standard-of-care (SOC) or are unwilling to undergo or intolerant to SOC;\n* Expected survival ≥ 3 months;\n* Subjects must have at least one measurable lesion as defined by RECIST v1.1. If no measurable lesion untreated with radiation is selected as the target lesion, a lesion treated with radiation ≥ 4 weeks before the first dose and with progression confirmed by radiography may be selected as the target lesion;\n* Eastern Cooperative Oncology Group(ECOG) performance status 0-1;\n* The organ functions of subjects meet the criteria for the following laboratory parameters at screening;\n* Subjects must be able to swallow oral medications without gastrointestinal abnormalities that significantly affect drug absorption\n\nExclusion Criteria:\n\n* Patients with previous (≤ 3 years) or current tumors of other pathological types, except for cured cervical carcinoma in situ, ductal carcinoma in situ of the breast, prostatic intraepithelial neoplasia, superficial non-invasive bladder cancer, stage I skin cancer (except melanoma); subjects without recurrence or metastasis for \\> 3 years after treatment, without current evidence of tumor, and without significant risk of recurrence of previous malignant diseases in the opinion of the study doctor may also be enrolled;\n* Serious allergy to the investigational drug or excipients (such as microcrystalline cellulose, etc.);\n* Patients with previous (≤ 6 months before the initiation of treatment) or current severe autoimmune diseases (including adverse reactions caused by previous anti- tumor immunotherapies), or autoimmune diseases requiring long-term systemic hormone therapy at immunosuppressive dose levels (prednisone \\> 10 mg\u002Fday or equivalent drugs);\n* HIV, hepatitis B virus(HBV), or hepatitis C virus(HCV) positive;\n* Previous (≤ 6 months prior to the first dose) or current evidence of the following diseases: acute myocardial infarction, unstable angina and cerebrovascular accident;\n* Subjects who have impaired cardiac functions or clinically significant cardiac diseases;\n* Pregnant or lactating women",{"count":168,"type":20},240,[52,23],"This is a multicenter, open-label phase 1\u002F2a study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of JAB-21822 in combination with JAB-3312 in patients with advanced solid tumors harboring KRAS p.G12C mutation and to determine the RP2D for the combination therapy. In the dose expansion phase, preliminary efficacy and safety of the combination therapy at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.",[26,172,173,174],"Non-small Cell Lung Cancer","Colorectal Cancer","Pancreatic Ductal Carcinoma",{"date":153,"type":33},{"date":177,"type":33},"2022-04-14",{"date":179,"type":20},"2026-03",{"name":39,"class":40},27,{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":21,"phases":191,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},"100460522","phase-1-a-study-of-jab-21822-in-advanced-or-metastatic-nsclc-with-kras-pg12c-and-stk11-co-mutation-and-wild-type-keap1-100460522","NCT05276726","A Study of JAB-21822 in Advanced or Metastatic NSCLC With KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1","A Phase Ib\u002FII ,Single Arm, Multi-Center, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of JAB-21822 in Advanced or Metastatic Non-small Cell Lung Cancer With a KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1","Inclusion Criteria:\n\n1. Pathologically documented, locally-advanced or metastatic NSCLC with KRAS p.G12C mutation identified through molecular testing.\n2. STK11 co-mutation and KEAP1 Wild-Type (local confirmation)\n3. Treatment naïve or have received at least 1 prior standard therapy for advanced NSCLC\n4. ECOG 0-1\n\nExclusion Criteria:\n\n1. Has CNS metastases or carcinomatous meningitis, except treated CNS metastases with no evidence of radiographic progression or hemorrhage for at least 28 days\n2. Any severe and\u002For uncontrolled medical conditions\n3. Active infection requiring systemic treatment within 7 days\n4. Therapeutic radiation therapy within 3 weeks of study day 1",{"count":190,"type":20},104,[52,23],"Evaluate the safety and tolerability, drug levels, and clinical activity of JAB-21822 in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors with KRAS p.G12C mutation and a serine\u002Fthreonine kinase 11 (STK11) co-mutation.",[172],{"date":153,"type":33},{"date":196,"type":33},"2022-08-17",{"date":198,"type":20},"2026-02",{"name":39,"class":40},21,{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":21,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":67},"100428001","phase-3-to-assess-the-efficacy-and-safety-of-furmonertinib-versus-placebo-in-patients-with-epidermal-growth-factor-receptor-mutation-positive-stage-ii-iiia-non-small-cell-lung-carcinoma-following-complete-tumour-resection-with-or-without-adjuvant-chemotherapy-100428001","NCT04853342","To Assess the Efficacy and Safety of Furmonertinib Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy","A Phase III, Double-blind, Randomized, Placebo-Controlled Multi-centre, Study to Assess the Efficacy and Safety of Furmonertinib (AST2818) Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy","FORWARD","Inclusion Criteria:\n\n* Male or female, aged at least 18 years.\n* Histologically confirmed diagnosis of primary non-small lung cancer (NSCLC) on predominantly non-squamous histology.\n* MRI or CT scan of the brain must be done prior to surgery as it is considered standard of care.\n* Patients must be classified post-operatively as Stage IB, II, or IIIA on the basis of pathologic criteria.\n* Confirmation by the central laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M.\n* Complete surgical resection of the primary NSCLC is mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for the tumor.\n* Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.\n* World Health Organization Performance Status of 0 to 1.\n* Female patients should be using adequate contraceptive measures, should not be breastfeeding, and must have a negative pregnancy test prior to the first dose of the study drug; or female patients must have evidence of non-child-bearing potential.\n\nExclusion Criteria:\n\n* Pre-operative or post-operative or planned radiation therapy for the current lung cancer\n* Pre-operative (neo-adjuvant) platinum-based or other chemotherapy\n* Any prior anticancer therapy\n* Prior treatment with neoadjuvant or adjuvant EGFR-TKI at any time\n* Major surgery (including primary tumor surgery, excluding placement of vascular access) within 4 weeks of the first dose of study drug\n* Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4\n* Treatment with an investigational drug within five half-lives of the compound or any of its related material.\n* Patients who have had only segmentectomies or wedge resections\n* History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for \\> 5 years following the end of treatment.\n* Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.\n* Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV).\n* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9291.\n* Any of the following cardiac criteria:\n* Mean resting corrected QT interval (QTc) \\>470 msec, obtained from 3 ECGs, using the screening clinic ECG Machine-derived QTc value.\n* Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval.\n* Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.\n* Inadequate bone marrow reserve or organ function.","75 Years",{"count":211,"type":20},318,[78],"This is a phase 3 double-blind, randomized, placebo-controlled, study to assess the efficacy and safety of Furmonertinib (AST2818) versus placebo in patients with stage II-IIIA non-small cell lung cancer (NSCLC) with centrally confirmed, most common sensitising EGFR mutations (Ex19Del and L858R) either alone or in combination with other EGFR mutations as confirmed by a central test, who have had complete tumour resection, with or without postoperative adjuvant chemotherapy.",[215],"Non-small Cell Lung Carcinoma","2025-04-02",{"date":153,"type":33},{"date":219,"type":33},"2021-06-07",{"date":221,"type":20},"2030-01",{"name":39,"class":40},""]