Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20000 participants
OBSERVATIONAL
2018-08-01
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohorts 1
Non-small cell lung cancer patients with EGFR mutations. Group A ： Single EGFR Drive gene Mutations Group B ：EGFR co-mutant with De novo MET alterations Group C ：EGFR co-mutant with other genes including ALK , ROS , RET , BRAF .etc
Treatment
Treatment decisions guided by molecular profiling and clinical judgment of principal investigators
Cohorts 2
Non-small cell lung cancer patients with ALK-fusion positive.
Treatment
Treatment decisions guided by molecular profiling and clinical judgment of principal investigators
Cohorts 3
Non-small cell lung cancer patients with ROS-1-positive.
Treatment
Treatment decisions guided by molecular profiling and clinical judgment of principal investigators
Cohorts 4
Non-small cell lung cancer patients with Other Rare Mutations.
Treatment
Treatment decisions guided by molecular profiling and clinical judgment of principal investigators
Cohorts 5
Driver-negative lung cancer patients with ADC and SQC.
Treatment
Treatment decisions guided by molecular profiling and clinical judgment of principal investigators
Interventions
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Treatment
Treatment decisions guided by molecular profiling and clinical judgment of principal investigators
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years.
3. Histopathology or cytology confirmed lung cancer
4. ECOG \<=2.
5. Predicted survival ≥ 12 weeks.
6. Adequate bone marrow hematopoiesis and organ function
7. Presence of measurable lesions according to RECIST 1.1.
Exclusion Criteria
* Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose.
* Ongoing (or inability to discontinue) possibly potent CYP1A2, CYP3A inhibitor (1 week), or inducer (2 weeks) drug therapy or herbal supplements within 1-2 weeks prior to the first dose.
2. Presence of spinal cord compression or meningeal metastasis.
3. History of other malignant tumors within 2 years.
4. Adverse events (except alopecia of any degree) of CTCAE \> grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.
5. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
6. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
7. Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.
8. Heart-related diseases or abnormalities
9. Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.
10. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb drugs due to previous bowel resection.
11. Live vaccine was given 2 weeks before the first medication.
12. Women who are breastfeeding or pregnant.
13. Hypersensitivity to the test drug and the ingredients.
14. Other conditions assessed by the investigator to be unsuitable for participation in the study.
18 Years
ALL
No
Sponsors
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Hunan Province Tumor Hospital
OTHER
Responsible Party
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Yongchang Zhang
Professor, Director of Clinical Trial Center
Principal Investigators
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Locations
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Hunan Cancer Hospital
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20180176
Identifier Type: -
Identifier Source: org_study_id
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