[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"egfr-positive-non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:egfr-positive-non-small-cell-lung-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,40,63,91,124,151],{"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":14,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100637294","phase-2-firmonertinib-in-perioperative-treatment-of-resectable-stage-ii-iiib-egfr-mutated-lung-adenocarcinoma-100637294",false,"NCT07622706","Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma","An Open-label, Single-arm, Phase II Clinical Study of Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma","Inclusion Criteria:\n\n* 1.Prior to the initiation of any study-related procedures, including examinations, sample collection, or analyses, written informed consent was obtained from all participating patients.\n\n  2.Male or female, aged \\>=18 years; 3.Histologically or cytologically confirmed primary lung adenocarcinoma within 60 days prior to study entry.\n\n  4.Stage II-IIIB disease (AJCC 9th edition) confirmed by systematic imaging (contrast-enhanced chest\u002Fabdominal CT, brain CT\u002FMRI, bone scan, or PET\u002FCT), with lesions eligible for radical resection.\n\n  5.EGFR mutation-positive (19Del and\u002For L858R, with or without T790M) as determined by NGS testing of tumor tissue or blood.\n\n  6.At least one measurable lesion with a longest diameter \\>=10 mm on baseline CT scan (except lymph nodes, which must have a short-axis diameter \\>=15 mm), and suitable for accurate and repeated measurement.\n\n  7.ECOG performance status 0-1. 8. Female patients should take adequate and effective contraception, must not breastfeed, and have a negative pregnancy test before the first administration of the study drug; or female patients must meet the following criteria at screening to demonstrate infertility:\n  1. Postmenopausal, defined as older than 50 years of age and having no menstruation for at least 12 months after stopping all exogenous hormone therapy.\n  2. For women under 50 years old, if there is no menstruation for 12 months or longer after stopping exogenous hormone therapy, and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are in the postmenopausal range, they are considered postmenopausal.\n  3. Documented irreversible sterilization surgery, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, excluding tubal ligation.\n\n  9\\. Male patients should be willing to use barrier contraception, i.e., condoms.\n\nExclusion Criteria:\n\n* 1.Tumors with squamous cell carcinoma, large cell carcinoma, or neuroendocrine components such as small cell carcinoma.\n\n  2.Presence of EGFR exon 20 insertion mutation detected by genetic testing. 3.Prior exposure to other antitumor therapies before enrollment. 4.Major surgery within 4 weeks prior to the first dose of study drug (including surgery for the primary tumor, excluding procedures for vascular access).\n\n  5.Scheduled or planned medical procedures (e.g., endoscopy or biopsy) or surgical operations within the next 4 months.\n\n  6.The patient is pregnant or breastfeeding. 7.Use of strong CYP3A4 inhibitors within 7 days, or strong CYP3A4 inducers within 21 days prior to the first dose of study drug; use of traditional Chinese medicines or herbal preparations indicated for antitumor treatment, those with tumor adjuvant effects, or any other agents with known antitumor activity within 14 days prior to the first dose.\n\n  8.History of other malignancies or concurrent malignancies, except for those that have been definitively treated with curative intent and with no evidence of recurrence for at least 5 years (e.g., carcinoma in situ of the cervix, basal cell carcinoma of the skin, or papillary thyroid carcinoma).\n\n  9.Patients with severe or uncontrolled systemic diseases requiring treatment, deemed unsuitable for participation by the investigator. These include but are not limited to: uncontrolled hypertension, diabetes, chronic heart failure (NYHA class III-IV), unstable angina, myocardial infarction within the past year, active bleeding disorders; hepatitis B (including all HBsAg-positive patients), hepatitis C (HCV antibody positive), or human immunodeficiency virus (HIV) infection; as well as patients with active infections requiring intravenous treatment.\n\n  10.Patients with severe gastrointestinal dysfunction or clinical conditions that may affect the intake, transport, or absorption of the study drug, such as inability to take oral medication, uncontrolled nausea and vomiting, or a history of extensive gastrointestinal resection.\n\n  11\\. Meets any of the following cardiac assessment criteria: (1) Resting ECG corrected QT interval (QTc) \\>470 msec, with QTc corrected using the Fridericia formula (if the initial ECG shows QTc \\>470 ms, repeat the ECG twice and take the average of the three QTc results). (2) Any clinically significant abnormalities in heart rhythm, conduction, or morphology on resting ECG, such as complete left bundle branch block, second-degree or third-degree atrioventricular block, etc. (3) Any factors that increase the risk of QTc prolongation or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, sudden unexplained death in first-degree relatives under 40 years old, or taking any concomitant medication known to prolong the QT interval that cannot be discontinued.\n\n  12\\. History of interstitial lung disease (ILD), drug-induced interstitial lung disease, radiation pneumonitis requiring glucocorticoid treatment, or patients with clinical manifestations suspected to be interstitial lung disease.\n\n  13\\. Any of the following laboratory test results indicating insufficient bone marrow or organ reserve function: (1) Absolute neutrophil count \\\u003C1.5×10\\^9\u002FL; (2) Platelet count \\\u003C100×10\\^9\u002FL; (3) Hemoglobin \\\u003C90 g\u002FL; (4) Alanine aminotransferase (ALT) \\>2.5× upper limit of normal (ULN); (5) Aspartate aminotransferase (AST) \\>2.5×ULN; (6) Total bilirubin \\>1.5×ULN or, in the case of Gilbert's syndrome (unconjugated hyperbilirubinemia), \\>3×ULN; (7) Creatinine clearance \\\u003C50 mL\u002Fmin (calculated by the Cockcroft-Gault formula); (8) Prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT) \\>=1.5 times ULN; 14. Known or suspected allergy to pralsetinib or any other component of its formulation; 15. Other situations where the patient is unable to comply with study procedures, restrictions, or requirements, and the investigator considers that such patient should not or is unsuitable to participate in the study; 16. Patients currently or previously participating in any other anti-tumor clinical study.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2",[25,26,27],"NSCLC","EGFR Positive Non-small Cell Lung Cancer","Neoadjuvant Therapy","NOT_YET_RECRUITING","2026-05-28",{"date":31,"type":32},"2026-06-03","ACTUAL",{"date":34,"type":20},"2026-05-30",{"date":36,"type":20},"2029-11-30",{"name":38,"class":39},"Peking University Cancer Hospital & Institute","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":4},"100615864","phase-2-firmonertinib-160-mg-in-patients-with-egfr-mutant-advanced-nsclc-demonstrating-sd-after-8-week-induction-with-firmonertinib-80-mg-100615864","NCT07298148","Firmonertinib 160 mg in Patients With EGFR-Mutant Advanced NSCLC Demonstrating SD After 8 Week Induction With Firmonertinib 80 mg","A Multicenter, Prospective, Phase II, Single-Arm Study of Firmonertinib 160 mg in Patients With EGFR-Mutant Advanced NSCLC Demonstrating Stable Disease After 8 Week Induction With Firmonertinib 80 mg","Inclusion Criteria:\n\n* Age 18-75 years.\n* ECOG performance status 0-1; life expectancy ≥3 months.\n* Histologically\u002Fcytologically confirmed advanced\u002Fmetastatic non-squamous NSCLC unsuitable for curative therapy.\n* Documented EGFR 19del or L858R mutation.\n* No prior systemic therapy for advanced disease.\n* Stable disease after 8 weeks of Firmonertinib 80 mg daily.\n* more than 1 measurable lesion per RECIST v1.1.\n* Adequate hematologic, renal, hepatic, and coagulation function.\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Hypersensitivity to Firmonertinib or related compounds.\n* Other actionable oncogenic drivers (ALK, ROS1, RET, BRAF, NTRK, MET, KRAS, except TP53\u002FRB1).\n* Prior EGFR-TKI therapy or prohibited concomitant medications.\n* Unresolved toxicities \\>CTCAE Grade 1 (except allowed conditions).\n* Symptomatic CNS metastases or spinal cord compression.\n* GI disorders impairing drug absorption.\n* Uncontrolled systemic diseases or active infections (HBV\u002FHCV\u002FHIV).\n* Interstitial lung disease (history or active).\n* Clinically significant cardiac abnormalities including QTc \\>470 ms or LVEF \\\u003C50%.\n* Pregnancy or breastfeeding.\n* Any condition compromising compliance.\n* CR, PR, or PD at completion of induction therapy.","75 Years",{"count":49,"type":20},28,[23],"This study evaluates the efficacy and safety of Firmonertinib 160 mg once daily in patients with EGFR-mutant, advanced NSCLC who achieve stable disease after first-line Firmonertinib 80 mg for 8 weeks.",[53,26,54],"NSCLC Stage IV","EGFR-TKI Sensitizing Mutation","2026-01-18",{"date":57,"type":32},"2026-01-21",{"date":59,"type":20},"2026-01-01",{"date":61,"type":20},"2032-12-31",{"name":38,"class":39},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"100617758","phase-2-osimertinib-combined-with-savolitinib-in-the-treatment-of-nsclc-with-low-copy-number-met-amplification-100617758","NCT07322783","Osimertinib Combined With Savolitinib in the Treatment of NSCLC With Low Copy Number MET Amplification","Osimertinib Combined With Savolitinib in the Treatment of EGFR Mutated Osimertinib Resistant NSCLC With Low Copy Number MET Amplification","Inclusion Criteria:\n\n* 1\\. Histologically or cytologically confirmed incurable advanced or metastatic non-small cell lung cancer who resistant to resistant to osimertinib, chemo-immunotherapy or anti-angiogenesis.\n\n  2\\. At least 1 measurable lesion (RECIST 1.1). 3. MET amplification copy number below 5 by FISH. 4. Male or female patients age ≥18 years. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2. 6. Estimated OS ≥3 months. 7. Adequate hematologic and bone marrow functions. 8. Adequate renal and liver function. 9. Had recovered from all toxicities related to prior anticancer therapies to grade ≤ 2, except for patients with grade 2 nausea\u002Fvomiting and\u002For grade 2 diarrhea despite optimal supportive therapy who will not be allowed to participate in the study.\n\n  10\\. Willingness to use contraception by a method that is deemed effective by the investigator by both males and female patients of child bearing potential (postmenopausal women must have been amenorrhea for at least 12 months to be considered of non-childbearing potential) and their partners throughout the treatment period and for at least three months following the last dose of study drug.\n\n  11\\. Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the patient prior to any study-specific procedures).\n\n  12\\. Willingness and ability to comply with study procedures and follow-up examination.\n\nExclusion13. Any of the following cardiac criteria: screening period resting period QTC \\> 470 milliseconds (clinical electrocardiograph report value; if a single time\\> 470 milliseconds, take the average of 3 inspections); rhythm of resting electrocardiogram (ECG), any clinically important abnormality of conduction or morphology (e.g., complete left bundle branch block, Grade 3 heart block, Grade 2 heart block); family history of congenital long QT prolongation syndrome or long QT syndrome.\n\n14\\. Evidence of any serious or uncontrolled systemic disease; various chronic active infections such as hepatitis B (HBV-DNA ≥ 104 copy number\u002Fml or 2000 IU\u002Fml), hepatitis C and HIV; uncontrollable Hypertensive patients (requires 2 or more drugs to control blood pressure); unstable angina; angina pectoris within 3 months prior to study; congestive heart failure (NYHA class II or higher); myocardial infarction (NSTEMI or STEMI) history in 6 months before study enrollment; severe arrhythmia requiring medical attention; severe liver, kidney, gastrointestinal or metabolic diseases.\n\n15\\. Patients who are unable to taking drugs 16. Other malignancies need treatment; except effectively treated skin basal cell carcinoma, cutaneous squamous cell carcinoma, and\u002For effectively resected orthotopic cervical cancer and\u002For breast cancer.\n\n17\\. Female patients during pregnancy or lactation. 18. Previous allergies or intolerance to treatment with osimertinib and savolitinib.\n\n19\\. Any other condition or circumstance of that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.\n\nCriteria:\n\n\\-","80 Years",{"count":19,"type":20},[23],"Osimertinib combined with savolitinib in the treatment of EGFR mutated osimertinib resistant NSCLC with low copy number MET amplification There are unmet medical needs in patients who resist to to osimertinib; savolitinib plus osimertinib shows high response rate and prolong progression-free survival in high copy number MET amplification patients. This study is to explore the efficacy and safety of the combination of savolitinib and osimertinib in osimertinb resistant patients with low copy number MET amplification.",[26,75],"MET Amplification",[77,78,79],"Savolitinib","Osimertinib","Drug Resistant","RECRUITING","2025-12-29",{"date":83,"type":32},"2026-01-07",{"date":85,"type":32},"2025-01-01",{"date":87,"type":20},"2026-12-31",{"name":89,"class":39},"Qingdao Central Hospital",1,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":101,"conditions":102,"keywords":110,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":90},"100431655","patient-centered-optimal-integration-of-survivorship-and-palliative-care-100431655","NCT04900935","Patient-centered, Optimal Integration of Survivorship and Palliative Care","Inclusion Criteria:\n\n* Age 18 or older\n* MGH Cancer Center patient\n* Within 6 months of diagnosis of metastatic NSCLC with oncogenic driver mutation (EGFR, ALK, ROS1, RET)\n* Receiving targeted therapy\n* Ability to respond in English or Spanish\n\nExclusion Criteria:\n\n* Cognitive impairment or serious mental illness that limits ability to provide informed consent\n* Need for urgent palliative care or hospice referral\n* Pregnant women\n* Prisoners",{"count":98,"type":20},70,[100],"NA","The goal of this study is to develop and test the feasibility of a supportive care model (POISE) for patients with metastatic Non-small Cell Lung Cancer (NSCLC). The main questions are\n\n* is POISE feasible to deliver and acceptable to patients\n* what is the effect of POISE on the distress patients feel related to their uncertain future, their confidence in their ability to manage cancer, and their understanding about what to expect Participants in the randomized controlled trial will receive either the new supportive care model, POISE, which consists of four visits with a trained palliative care clinician, or care as usual, and will be asked to complete three surveys.",[103,104,105,106,107,26,108,109],"Stage IV Non-small Cell Lung Cancer","Targeted Therapy","Nonsmall Cell Lung Cancer","Carcinoma, Non-Small-Cell Lung","ALK-positive Non-small Cell Lung Cancer","Palliative Care","Survivorship",[103,104,105,106,107,26,111,112,113,114],"ROS1 Positive Non-Small Cell Lung Cancer","Palliative care","survivorship","RET Fusion positive Non-Small Cell Lung Cancer","2025-11-19",{"date":117,"type":32},"2025-11-24",{"date":119,"type":32},"2023-09-29",{"date":121,"type":20},"2027-09-01",{"name":123,"class":39},"Massachusetts General Hospital",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":131,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":135,"phases":4,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":90},"100442126","osimertinib-for-advanced-egfr-positive-nsclc-patients-100442126","NCT05037331","Osimertinib for Advanced EGFR-positive NSCLC Patients","Improvement of the Value of Orally Administered Cancer Drugs: Arm 1: Osimertinib for Advanced EGFR-positive NSCLC Patients: A Phase II Study","Inclusion Criteria:\n\n* For inclusion in the study subjects should fulfil the following criteria:\n\n  1. Provision of informed consent prior to any study-specific procedure\n  2. Patients must be ≥ 18 years old\n  3. Locally advanced \u002Fmetastatic NSCLC not responsive to surgery or radiotherapy\n  4. Validated activating EGFR sensitising mutations with or without T790M resistance mutation at the time of recruitment for patients who have no prior EGFR TKI treatment.\n  5. Patients must be EGFR treatment naïve.\n  6. ECOG Performance status is 0-1 with no deterioration over the last 2 weeks prior to study recruitment.\n  7. Normal organ and bone marrow function measured within 28 days before the study as defined below:\n\n     * Haemoglobin ≥ 9.0 g\u002FdL and no blood transfusions in the 28 days prior to entry\n     * Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL\n     * No features suggestive of MDS\u002FAML on peripheral blood smear\n     * White blood cells (WBC) \\> 3x109\u002FL\n     * Platelet count ≥ 100 x 109\u002FL\n     * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)\n     * AST (SGOT)\u002FALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN\n     * Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN)\n     * ECOG performance status 0-2\n  8. A life expectancy ≥ 12 weeks in all patients.\n  9. Females in childbearing age should be using adequate contraceptive measures, should not be breastfeeding and their pregnancy test prior to the start of treatment must be negative. Evidence of non-child-bearing potential is fulfilled by one of the following criteria at screening:\n\n     * The post-menopausal period defined as age ≥50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments\n     * Women \\\u003C50 years old they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range.\n     * Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not a tubal ligation\n  10. Male patients should be willing to use barrier contraception\n  11. The patient is willing to comply with the protocol during the study including undergoing treatment and scheduled visits and examinations including follow up.\n  12. At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is considered suitable for accurate repeated measurements.\n\nExclusion Criteria:\n\n* Patients should not enter the study if any of the following exclusion criteria are fulfilled:\n\n  1. Treatment with other EGFR-TKI within 8 days or within five half-lives of the compound before study entry whichever is the longer; any cytotoxic chemotherapy, or other anticancer drugs against NSCLC within 14 days of study entry\n  2. Previously treated with an immune checkpoint inhibitor\n  3. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years\n  4. Radiotherapy to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks before the study entry\n  5. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of study treatment with the exception of alopecia grade 2 and platinum-related neuropathy.\n  6. Unstable spinal cord compression\u002Fbrain metastases unless asymptomatic and not requiring steroids for at least 2 weeks prior to the start of study treatment. For patients with brain metastases, gamma knife or stereotactic brain surgery is allowed prior to study treatment.\n  7. Major surgery within 4 weeks of starting study treatment and patients must have recovered from any effects of any major surgery. Minor surgery is allowed.\n  8. Patients currently receiving or unable to stop use medications or herbal supplements that are potent inhibitors of CYP3A4 (at least 1 week prior) and potent inducers of CYP3A4 (at least 3 weeks prior). All patients must avoid concomitant use of any medications, herbal supplements and\u002For foods with known inducer\u002Finhibitory effects on CYP3A4 unless part of protocol treatment.\n  9. Severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which based on investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or having active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.\n  10. Past medical history of ILD, drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD\n  11. Any of the following cardiac criteria:\n\n      1. Mean resting corrected QT interval (QTc using Fredericia's formula) \\> 470 msec\n      2. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block)\n      3. Any factors increasing the risk of QTc prolongation or arrhythmias such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval\n  12. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the drug or previous significant bowel resection that would preclude adequate absorption of Osimertinib\n  13. History of hypersensitivity to Osimertinib (or drugs with a similar chemical structure or class to Osimertinib) or any excipients of these agents\n  14. Males and females of reproductive potential who are not using an effective method of contraception and females who are pregnant or breastfeeding or have a positive serum pregnancy test prior to study entry\n  15. Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements\n  16. Previous allogeneic bone marrow transplant.","21 Years","99 Years",{"count":134,"type":20},58,"OBSERVATIONAL","Lung cancer is the leading cause of cancer incidence (11.6%) and mortality (18.4%) globally\\[1\\]. Development of targeted therapies in the context of precision medicine changed the way lung cancer was diagnosed and treated. Small molecule inhibitors, like tyrosine kinase inhibitors (TKIs), are now standard first-line therapy for EGFR-positive non-small cell lung cancer (NSCLC). First-generation EGFR-TKIs gefitinib and erlotinib bind competitively to the ATP-binding site of EGFR TK domain. This binding in second-generation TKI afatinib is irreversible. These drugs have improved better outcome compared to standard conventional chemotherapy In spite of this, more than half of the patients with an EGFR TKI treatment develop resistance. Deletion in exon 19 and single point substitution L858R in exon 21 accounting for 44% and 41% of all EGFR mutations, respectively are the most common mutations in EGFR gene which cause this resistance in the patients. Asia has the highest prevalence of EGFR mutations (38.4%), followed by America (24.4%) and Europe (14.1%). Median progression-free survival of EGFR mutated NSCLC patients under erlotinib or gefitinib has been around 12 months and 5-year survival was 15%",[26,138],"Non Small Cell Lung Cancer",[78,140,25,141],"advanced EGFR-positive","orally administered","2025-09-22",{"date":144,"type":32},"2025-09-25",{"date":146,"type":32},"2021-07-22",{"date":148,"type":20},"2026-06",{"name":150,"class":39},"National University Hospital, Singapore",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":158,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":162,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":175,"leadSponsor":177,"locationsCount":4},"100513173","phase-2-neoadjuvant-toripalimab-for-non-squamous-nsclc-with-egfr-mutation-100513173","NCT05962021","Neoadjuvant Toripalimab for Non-squamous NSCLC With EGFR Mutation","Neoadjuvant Toripalimab Plus Chemotherapy for Resectable Stage II-IIIB Non-squamous Non-small Cell Lung Cancer With EGFR Mutation: a Multicentre, Multi-cohort, Exploratory Study.","Inclusion Criteria:\n\n1. Provision of signed informed consent by the patient or legally acceptable representative;\n2. Previously untreated, histologically confirmed resectable stage II-IIIA, IIIB(N2) (AJCC staging 8th edition) non-squamous non-small cell lung cancer;\n3. Adequate tissue samples for PD-L1 immunohistochemical testing and gene mutations test by RT-pCR or NGS, or consent for blood RT-PCR or NGS if tissue samples are insufficient;\n4. Harboring EGFR mutation (19del or L858R);\n5. Aged 18-70 years, regardless of gender;\n6. Eastern Cooperative Group (ECOG) Performance Status 0-1;\n7. Acceptable cardiac function with a left ventricular ejection fraction \\>50%;\n8. Acceptable respiratory function (FEV1\\>1.5L, DLCO\\>50%) and ability to tolerate radical lung cancer surgery;\n9. Acceptable bone marrow haematopoiesis with leucocytes ≥ 4 x 10\\^9\u002FL, neutrophils ≥ 1.5 x 10\\^9\u002FL, haemoglobin ≥ 10g\u002FdL and platelets ≥ 100 x 10\\^9\u002FL;\n10. Acceptable renal function with a glomerular filtration rate ≥ 60 mL\u002Fmin;\n11. Acceptable liver function with total bilirubin ≤ 1.5 x ULN, AST ≤ 3 x ULN, and ALT ≤ 3 x ULN;\n12. Presence of measurable lesions as defined by RECIST 1.1 criteria;\n13. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 3 days prior to the start of study treatment, and agree to use effective contraception for the duration of study drug use and for 120 days after the last dose. Women of childbearing potential were defined as sexually mature females who 1) had not undergone hysterectomy or bilateral oophorectomy and 2) had not experienced spontaneous menopause for 12 consecutive months (amenorrhea after cancer treatment did not preclude fertility) (menstruation had occurred at any time during the previous 12 consecutive months).\n\nExclusion Criteria:\n\n1. Pathological histologically confirmed small cell lung cancer, squamous epithelial cell carcinoma and other pathological subtypes cannot be enrolled;\n2. Patients with advanced or metastatic lung cancer, or unresectable lung cancer, or who have received previous systemic anti-tumour therapy such as immunotherapy, chemotherapy or targeted therapy cannot be enrolled;\n3. Patients with a history of active autoimmune disease or autoimmune disease that is likely to recur cannot be enrolled;\n4. Patients with active hepatitis B and C requiring relevant antiviral therapy need to have HBV-DNA \\\u003C500 IU\u002Fml and have been on anti-HBV treatment for at least 14 days prior to study entry and continue treatment during the treatment period; HCV RNA-positive patients should be excluded;\n5. Patients who are allergic to chemotherapeutic agents such as carboplatin, paclitaxel, albumin paclitaxel, pemetrexed;\n6. Patients with a history of allergy to monoclonal antibody drugs;\n7. Patients who have previously received an allogeneic stem cell transplant or organ transplant；\n8. Patients with mental illness or any other illness that makes it impossible to comply with treatment；\n9. Patients who are unable or unwilling to sign the informed consent form；\n10. Patients with comorbidities or other conditions that, in the opinion of the investigator, may affect compliance with the protocol or make them unsuitable for participation in this study.","17 Years","70 Years",{"count":161,"type":20},126,[23],"This study was designed to investigate the efficacy and safety of neoadjuvant Toripalimab (anti-PD1) plus chemotherapy for patients with resectable II-IIIB non-squamous NSCLC harboring EGFR mutation, and to explore the potential predictive and prognostic biomarkers, aiming to provide more abundant evidences for the preoperative treatment decision of non-squamous NSCLC patients.",[165,26],"Non Squamous Non Small Cell Lung Cancer",[167,168,169,170],"Non squamous non small cell lung cancer","EGFR Mutation","Neoadjuvant immuno-chemotherapy","Predictive and prognostic biomarker","2023-07-28",{"date":173,"type":32},"2023-08-01",{"date":173,"type":20},{"date":176,"type":20},"2026-06-30",{"name":178,"class":39},"Peking University People's Hospital"]