Survival Outcomes for Lung Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Treatment
- Conditions
- Not specified
- Sponsor
- Hunan Province Tumor Hospital
- Enrollment
- 20000
- Locations
- 1
- Primary Endpoint
- Progression-free survival (PFS)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This is a prospective study to analyze the survival outcomes of different groups about lung cancer patients.
Detailed Description
This study aims to analyze the survival outcomes of different groups about lung cancer patients. All the groups were assessed to the treatment decisions guided by molecular profiling and clinical judgment of principal investigators
Investigators
Yongchang Zhang
Professor, Director of Clinical Trial Center
Hunan Province Tumor Hospital
Eligibility Criteria
Inclusion Criteria
- •Understand the requirements and contents of the clinical trial .
- •Age ≥ 18 years.
- •Histopathology or cytology confirmed lung cancer
- •Predicted survival ≥ 12 weeks.
- •Adequate bone marrow hematopoiesis and organ function
- •Presence of measurable lesions according to RECIST 1.1.
Exclusion Criteria
- •Subjects who have received any of the following treatments must be excluded:
- •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.
- •Presence of spinal cord compression or meningeal metastasis.
- •History of other malignant tumors within 2 years.
- •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.
- •History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
- •The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
- •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.
- •Heart-related diseases or abnormalities
Arms & Interventions
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
Intervention: Treatment
Cohorts 2
Non-small cell lung cancer patients with ALK-fusion positive.
Intervention: Treatment
Cohorts 3
Non-small cell lung cancer patients with ROS-1-positive.
Intervention: Treatment
Cohorts 4
Non-small cell lung cancer patients with Other Rare Mutations.
Intervention: Treatment
Cohorts 5
Driver-negative lung cancer patients with ADC and SQC.
Intervention: Treatment
Outcomes
Primary Outcomes
Progression-free survival (PFS)
Time Frame: Time from first subject dose to study completion, or up to 5 years
PFS defines as first dose to first documented disease progression assessed by investigator or death due to any cause.
Secondary Outcomes
- Overall survival (OS)(Time from first subject dose to study completion, or up to 5 years)
- Adverse events (AEs)(Time from first subject dose to study completion, or up to 5 years)