[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alk-positive-non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alk-positive-non-small-cell-lung-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,66,101,123],{"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":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100630732","phase-1-a-phase-12-study-of-tri-611-in-alk-positive-nsclc-100630732",false,"NCT07491497","A Phase 1\u002F2 Study of TRI-611 in ALK-Positive NSCLC","A Phase 1\u002F2, Dose Escalation and Expansion Study of TRI-611, an Oral ALK Molecular Glue Degrader in Participants With Advanced ALK-Positive NSCLC","Inclusion Criteria:\n\n* Pathologically confirmed diagnosis of ALK-positive non-small cell lung cancer (NSCLC)\n* Measurable disease per RECIST v1.1\n* Adequate bone marrow reserve and organ function\n* Part 1: prior treatment with 2 to 3 ALK TKIs, prior treatment with lorlatinib is required but must not have been in the first line\n* Part 2 Cohort M1: prior treatment with 2 to 3 ALK TKIs, prior treatment with lorlatinib is required but must not have been in the first line, prior treatment with neladalkib is excluded\n* Part 2 Cohort M2: prior treatment with more than 3 ALK TKIs, prior treatment with lorlatinib and neladalkib is required but neither may have been in the first line\n* Part 2 Cohort M3: participants without prior ALK TKI treatment\n\nExclusion Criteria:\n\n* Participant's cancer has any additional driver alterations known to be a mechanism of resistance to ALK TKIs\n* For participants with central nervous system (CNS) metastases or spinal cord compression, they must not be associated with progressive neurological symptoms or require increasing doses of corticosteroids to control the CNS disease\n* Ongoing treatment with another anticancer treatment or investigational agent\n* Known allergy\u002Fhypersensitivity to TRI-611 or any of its ingredients\n* Major surgery within 4 weeks of receiving the first dose of TRI-611","ALL","18 Years",{"count":19,"type":20},160,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The goal of this clinical trial is to learn about the safety and recommended dose of TRI-611 when administered to adults with ALK-positive non-small cell lung cancer (NSCLC). The trial will also evaluate the antitumor activity of TRI-611 in adults with ALK-positive NSCLC.\n\nThe study will be conducted in two parts. The first part will examine different doses of TRI-611. The second part will look at how well TRI-611 works on ALK-positive NSCLC when administered to three groups of participants that differ based on what type of prior therapy they have received.\n\nIn this study participants will:\n\n* Take TRI-611 on a continued basis, provided it is well-tolerated, for as long as their disease is not progressing\n* Visit the clinic approximately seven times in the first 3 months and then just once at the start of each 28-day cycle thereafter\n* Keep a diary of each time they take the study medication",[27,28,29],"ALK-positive NSCLC","ALK-Positive Lung Cancer","ALK-positive Non-small Cell Lung Cancer","RECRUITING","2026-06-15",{"date":33,"type":34},"2026-06-16","ACTUAL",{"date":36,"type":34},"2026-03-11",{"date":38,"type":20},"2034-01-30",{"name":40,"class":41},"TRIANA Biomedicines, Inc.","INDUSTRY",9,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":4},"100638512","phase-1-aqua07-in-patients-with-alk-positive-non-small-cell-lung-cancer-100638512","NCT07617337","AQUA07 in Patients With ALK-Positive Non-Small Cell Lung Cancer","A Phase I, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of AQUA07 Monotherapy and Combination Therapy in Patients With Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years (or ≥ 20 years if required by local regulation) at time of signing Informed Consent Form\n* Previously treated with at least one ALK-TKI regardless of prior chemotherapy treatment (Patients who have received only crizotinib as prior ALK-TKI treatment will not be allowed.)\n* Histologically or cytologically (excluding sputum cytology) proven diagnosis of locally advanced unresectable or metastatic ALK-positive NSCLC\n* Measurable disease per RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Ability and willingness to take oral medication(s)\n* Adequate organ function and bone marrow reserve\n\nExclusion Criteria:\n\n* Prior toxicities from anti-cancer therapy which have not resolved to Grade ≤ 1 per NCI CTCAE v5.0 excluding alopecia, vitiligo, or endocrinopathies manageable with replacement therapy\n* Symptomatic, active CNS metastases or untreated CNS metastases requiring any definitive therapy.\n* Severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or renal disease, or active infection), or with a history or complication of interstitial lung disease\n* Significant cardiovascular disease\n* Inadequately controlled hypertension",{"count":51,"type":20},102,[23],"This is a first-in-human, Phase I, open-label, multicenter, multinational study, designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of AQUA07 when administered as single agent and in combination with lorlatinib in patients with ALK positive non-small cell lung cancer.",[55],"ALK Positive Non-small Cell Lung Cancer","NOT_YET_RECRUITING","2026-05-24",{"date":59,"type":34},"2026-06-01",{"date":61,"type":20},"2026-07-31",{"date":63,"type":20},"2030-08-31",{"name":65,"class":41},"Chugai Pharmaceutical",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":76,"conditions":77,"keywords":85,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":100},"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":73,"type":20},70,[75],"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.",[78,79,80,81,29,82,83,84],"Stage IV Non-small Cell Lung Cancer","Targeted Therapy","Nonsmall Cell Lung Cancer","Carcinoma, Non-Small-Cell Lung","EGFR Positive Non-small Cell Lung Cancer","Palliative Care","Survivorship",[78,79,80,81,29,82,86,87,88,89],"ROS1 Positive Non-Small Cell Lung Cancer","Palliative care","survivorship","RET Fusion positive Non-Small Cell Lung Cancer","2025-11-19",{"date":92,"type":34},"2025-11-24",{"date":94,"type":34},"2023-09-29",{"date":96,"type":20},"2027-09-01",{"name":98,"class":99},"Massachusetts General Hospital","OTHER",1,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":100},"100543878","real-world-study-of-lolatinib-for-advanced-alk-nsclc-patients-100543878","NCT06361589","Real World Study of Lolatinib for Advanced ALK+ NSCLC Patients","Real World Study of Lolatinib for Patients With Advanced\u002FMetastatic Anaplastic Lymphoma Kinase (ALK) - Positive Non-Small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n1. Voluntary participation in this clinical study, understanding of study procedures, and ability to sign written informed consent.\n2. Age ≥18 years.\n3. Locally advanced or metastatic (inoperable stage IIIa or IIIb-IV) NSCLC with disease staging according to the American Joint Committee on Cancer (AJCC)\u002FUICC 8th edition lung cancer staging criteria.ALK fusion mutations confirmed by tumor histology or hematology.\n4. Expected survival greater than 12 weeks.\n5. Adequate bone marrow reserve, organ function, and coagulation as assessed by the investigator as evidenced by complete blood count, biochemical parameters in blood and urine, coagulation, and electrocardiogram or cardiac ultrasound at baseline.\n6. Can take the medicine orally and swallow it.\n7. Female patients of childbearing potential are willing to use appropriate contraception and should not breastfeed within 6 months from signing the main informed consent to efficacy evaluation\u002Fend of medication (whichever is later); Male patients were willing to use barrier contraception (i.e., condom) for 6 months from signing the main informed consent until the efficacy assessment\u002Fend of medication, whichever occurred later.\n8. Female patients have a negative blood pregnancy test within 3 days before enrollment or meet one of the following criteria to demonstrate no risk of pregnancy: a. Postmenopausal is defined as age 50 years or older and amenorrhea for at least 12 months after cessation of all exogenous hormone replacement therapy; b. Females less than 50 years of age may also be considered postmenopausal if they have been amenorrhoeic for 12 months or more after cessation of all exogenous hormonal therapy and have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels within the laboratory postmenopausal reference values; c. History of irreversible sterilization, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, except for bilateral tubal ligation.\n\nExclusion Criteria:\n\n1. Use of strong CYP3A4 inhibitors, strong inducers, or drugs with a narrow therapeutic window that are sensitive substrates of CYP3A4 within 7 days and need to continue treatment with these drugs during the study.\n2. Patients with known active infectious diseases, such as active hepatitis B or C or HIV infection of human immunodeficiency virus, active hepatitis B and C including hepatitis B or C surface antigen (+) patients receiving intravenous treatment for infection - patients receiving oral antiviral suppression of hepatitis B or C will be allowed to participate in the study.\n3. Any other disease, metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the judgment of the investigator, has reason to suspect that the patient has a disease or condition that is not appropriate for the use of lorlatinib, or would affect the interpretation of the study results, or place the patient at high risk.\n4. Female patients who are pregnant, breastfeeding, or plan to become pregnant during the study.\n5. Patients with hypersensitivity to any active or inactive ingredient of lorlatinib.\n6. Any other patient who, in the judgment of the investigator, may have poor compliance with the study procedures and requirements.",{"count":109,"type":20},200,"OBSERVATIONAL","This study was a multicenter, prospective, non-interventional clinical study that included first-line and late-line patients with advanced non-small cell lung cancer with ALK fusions treated with the third generation ALK-TKI lorlatinib until disease progression, intolerable toxicity, investigator or subject decision to withdraw, lost to follow-up, initiation of other antineoplastic therapy, or death. Clinical pathology including sex, age, ALK mutation status at diagnosis, and clinical stage at diagnosis were collected from medical records. Physical condition as assessed by ECOG-PS before administration of lorlatinib was also recorded. Treatment information was obtained from the records, including dose and timing of ALK-TKI therapy and tumor response, number of prior systemic lines of therapy, and local treatment modalities such as radiotherapy and surgery. Quality of life based on the EORTC QLQ C30+LC29 scale (plus the EORTC QLQ BN20 scale in patients with brain\u002Fmeningeal metastases) was performed at baseline and at each follow-up point. This study will use REDCap platform to collect and manage the study data information of multi-center patients.",[29,113],"Real World Study","2024-04-09",{"date":116,"type":34},"2024-04-12",{"date":118,"type":20},"2024-05-01",{"date":120,"type":20},"2028-11-01",{"name":122,"class":99},"Sichuan Cancer Hospital and Research Institute",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":100},"100523166","phase-2-lorlatinib-as-the-first-line-treatment-in-china-advanced-alk-nsclc-100523166","NCT06092086","Lorlatinib as the First-line Treatment in China Advanced ALK+ NSCLC","A Patient-Centric, Open-Label, Multicenter, Phase II Study of Lorlatinib Monotherapy in The First-Line Treatment of Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer","Inclusion Criteria:\n\nInclusion Criteria of CROWN Criteria (CC) Cohort\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:\n\n1. Diagnosis:\n\n   1. Study Population: Patients with histologically or cytologically confirmed diagnosis of locally advanced \\[(Stage IIIB\u002FC not amenable for multimodality treatment) or metastatic (Stage IV) by American Joint Committee on Cancer (AJCC) v 7.0\\] ALK-positive NSCLC where ALK status is determined by the Ventana ALK (D5F3) Companion Diagnostic (CDx) IHC test performed on the Ventana ULTRA or XT Platforms, FISH, PCR, or next generation sequencing (NGS), or circulating tumor DNA (ctDNA).\n   2. Tumor Requirements: At least 1 extracranial measurable target lesion per RECIST v. 1.1 that has not been previously irradiated. CNS metastases are allowed if asymptomatic and:\n\n      1. Either untreated and not currently requiring corticosteroid treatment, or on a stable or decreasing dose of ≤10 mg QD prednisone or equivalent; or\n      2. Local treatment has been completed with full recovery from the acute effects of radiation therapy or surgery prior to randomization, and if corticosteroid treatment for these metastases has been withdrawn for at least 4 weeks with neurological stability; or\n      3. In case of leptomeningeal disease (LMD) or carcinomatous meningitis (CM) if visualized on magnetic resonance imaging (MRI), or if baseline CSF positive cytology is available.\n   3. Tissue Requirements: All patients must have an archival formalin fixed, paraffin embedded (FFPE) tissue specimen available and collected prior to randomization. If archived tissue is unavailable, then a mandatory de novo biopsy must be performed.\n2. No prior systemic NSCLC treatment for advanced (Stage IIIB\u002FC not amenable for multimodality treatment) or metastatic (Stage IV) disease, including molecularly targeted agents (e.g., ALK TKIs), angiogenesis inhibitors, immunotherapy, or chemotherapy. Prior treatment for earlier Stages of the NSCLC only allowed if completed more than 12 months prior to randomization.\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, 1, or 2.\n4. Age ≥18 years.\n5. Adequate Bone Marrow Function, including:\n\n   1. Absolute Neutrophil Count (ANC) ≥ 1,500\u002Fmm3 or ≥1.5 x 109\u002FL;\n   2. Platelets ≥100,000\u002Fmm3 or ≥100 x 109\u002FL;\n   3. Hemoglobin ≥9 g\u002FdL.\n6. Adequate Pancreatic Function, including:\n\n   1. Serum total amylase ≤1.5 x upper limit of normal (ULN)\\*;\n   2. Serum lipase ≤1.5 x ULN. \\*if total amylase \\>1.5 x ULN, but pancreatic amylase is within the ULN, then patient may be enrolled.\n7. Adequate Renal Function, including:\n\n   a. Serum creatinine ≤1.5 x ULN or estimated creatinine clearance ≥60 mL\u002Fmin as calculated using the method standard for the institution.\n8. Adequate Liver Function, including:\n\n   1. Total serum bilirubin ≤1.5 x ULN;\n   2. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤2.5 x ULN (≤5.0 x ULN in case of liver metastases).\n9. Acute effects of prior radiotherapy resolved to baseline severity or to CTCAE Grade ≤1 except for AEs that in the investigator's judgment do not constitute a safety risk for the patient.\n10. Serum pregnancy test (for females of childbearing potential) negative at screening. Female patients of non-childbearing potential must meet at least 1 of the following criteria:\n\n    1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause (which may be confirmed with a serum follicle-stimulating hormone \\[FSH\\] level confirming the postmenopausal state if appropriate);\n    2. Have undergone a documented hysterectomy and\u002For bilateral oophorectomy;\n    3. Have medically confirmed ovarian failure. All other female patients (including female patients with tubal ligations) are considered to be of childbearing potential.\n11. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.\n12. Willing and able to comply with scheduled visits, treatment plans, laboratory tests and other procedures.\n\nInclusion Criteria of Compassionate use (CU) Cohort\n\n1. Diagnosed as ALK-positive NSCLC as in CC cohort, but not fulfilled CC cohort inclusion criteria 2\\~9 as above mentioned.\n2. No prior ALK TKI treatment for advanced (Stage IIIB\u002FC not amenable for multimodality treatment) or metastatic (Stage IV) disease (e.g., alectinib, brigatinib).\n3. Serum pregnancy test (for females of childbearing potential) negative at screening.\n4. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.\n5. Willing and able to comply with scheduled visits, treatment plans, laboratory tests and other procedures.\n\nExclusion Criteria:\n\nSubjects presenting with any of the following characteristics\u002Fconditions will not be included in this clinical study:\n\n1. Spinal cord compression unless the patient has good pain control attained through therapy, and there is stabilization or recovery of neurological function for the 4 weeks prior to randomization.\n2. Major surgery within 4 weeks prior to randomization. Minor surgical procedures (e.g., port insertion) are not excluded, but sufficient time should have passed for adequate wound healing.\n3. Radiation therapy within 2 weeks prior to randomization, including stereotactic or partial brain irradiation. Patients who complete whole brain irradiation within 4 weeks prior to randomization or palliative radiation therapy outside of the CNS within 48 hours prior to randomization will also not be included in the study.\n4. Gastrointestinal abnormalities, including inability to take oral medication; requirement for intravenous alimentation; prior surgical procedures affecting absorption including total gastric resection or lap band; active inflammatory gastrointestinal disease, chronic diarrhea, symptomatic diverticular disease; treatment for active peptic ulcer disease in the past 6 months; malabsorption syndromes.\n5. Known prior or suspected severe hypersensitivity to study drugs or any component in their formulations.\n6. Active and clinically significant bacterial, fungal, or viral infection including hepatitis B virus (HBV) or hepatitis C virus (HCV) (e.g., in case of known HBsAg or HCV antibody positivity), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness.\n7. Clinically significant vascular (both arterial and venous) and non-vascular cardiac conditions, (active or within 3 months prior to enrollment), which may include, but are not limited to:\n\n   1. Arterial disease such as cerebral vascular accident\u002Fstroke (including Transient Ischemic Attack -TIA), myocardial infarction, unstable angina;\n   2. Venous diseases such as cerebral venous thrombosis, symptomatic pulmonary embolism;\n   3. Non-vascular cardiac disease such as congestive heart failure (New York Heart Association Classification Class ≥ II), second-degree or third-degree AV block (unless paced) or any AV block with PR \\>220 msec; or ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2, uncontrolled atrial fibrillation of any grade, bradycardia defined as \\\u003C50 bpm (unless patient is otherwise healthy such as long-distance runners, etc.), machine-read Electrocardiogram (ECG) with QTc \\>470 msec, or congenital long QT syndrome.\n8. Patients with predisposing characteristics for acute pancreatitis according to investigator judgment (e.g., uncontrolled hyperglycemia, current gallstone disease) in the last month prior to randomization.\n9. History of extensive, disseminated, bilateral or presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis.\n10. Evidence of active malignancy (other than NSCLC, non-melanoma skin cancer, or localized prostate cancer or any in situ cancer which does not currently require treatment) within the last 3 years prior to randomization.\n11. Concurrent use of any of the following food or drugs (consult the sponsor if in doubt whether a food or a drug falls into any of the above categories) within 12 days prior to the first dose of lorlatinib.\n\n    1. Known strong CYP3A inhibitors (e.g., strong CYP3A inhibitors: grapefruit juice or grapefruit\u002Fgrapefruit related citrus fruits \\[eg, Seville oranges, pomelos\\], boceprevir, cobicistat, conivaptan, itraconazole, ketoconazole, posaconazole, ritonavir alone and with danoprevir or elvitegravir or indinavir or lopinavir or paritaprevir or ombitasvir or dasabuvir or saquinavir or tipranavir, telaprevir, troleandomycin, and voriconazole. The topical use of these medications (if applicable), such as 2% ketoconazole cream, is allowed.\n    2. Known CYP3A substrates with narrow therapeutic index, such as astemizole\\*, terfenadine\\*, cisapride\\*, pimozide, quinidine, tacrolimus, cyclosporine, sirolimus, alfentanil, fentanyl (including transdermal patch) or ergot alkaloids (ergotamine, dihydroergotamine) (\\*withdrawn from US market).\n    3. Known strong CYP3A inducers (e.g., carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John's Wort). d. Known P-gp substrates with a narrow therapeutic index (e.g., digoxin).\n12. Other severe acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.\n13. Patients who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or patients who are Pfizer employees, including their family members, directly involved in the conduct of the study.\n14. Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry and\u002For during study participation.\n15. Pregnant female patients; breastfeeding female patients; fertile male patients and female patients of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 97 days, if male or 35 days if female, after the last dose of investigational product under lorlatinib.",{"count":131,"type":20},126,[24],"This phase II study is aim to investigate the efficacy, resistance mechanism, safety profile of first-line lorlatinib in China advanced ALK+ non-small cell lung cancer (NSCLC). Participants will receive continuous daily PO dosing of lorlatinib 100mg QD.",[55],"2023-10-19",{"date":137,"type":34},"2023-10-23",{"date":139,"type":34},"2023-08-18",{"date":141,"type":20},"2030-08-01",{"name":143,"class":99},"Guangdong Association of Clinical Trials"]