Status:
RECRUITING
Efficacy of Platinum-based Chemotherapy Plus Immune Checkpoint Inhibitors for EGFR/ALK/ROS1 Mutant Lung Cancer
Lead Sponsor:
Hunan Province Tumor Hospital
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The investigators want to evaluate the Efficay and Safety of Platinum-based Chemotherapy with or without immune checkpoint inhibitors for EGFR/ALK/ROS1 Positive NSCLC who Failed from First-Line Standa...
Detailed Description
The investigators want to evaluate the Efficacy and Safety of Platinum-based Chemotherapy with or without immune checkpoint inhibitors for EGFR/ALK/ROS1 Positive NSCLC who Failed from First-Line Stand...
Eligibility Criteria
Inclusion
- Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
- Age ≥ 18 years.
- Histologically or cytologically confirmed, Stage IV NSCLC.
- EGFR/ALK/ROS1-sensitive mutations confirmed by an accredited local laboratory, progressed from first line systematic therapy.
- ECOG 0-1.
- Predicted survival ≥ 12 weeks.
- Adequate bone marrow hematopoiesis and organ function
- Presence of measurable lesions according to RECIST 1.1.
Exclusion
- Cancer-Specific Exclusions:
- Active or untreated central nervous system metastases.
- Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome.
- General Medical Exclusions:
- Pregnant or lactating women.
- History of autoimmune disease.
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- Positive test for human immunodeficiency virus.
- Active hepatitis B or hepatitis C.
- Severe infection within 4 weeks prior to randomization.
- Significant cardiovascular disease.
- Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures.
- Exclusion Criteria Related to Medications:
- • Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 10 2027
Estimated Enrollment :
760 Patients enrolled
Trial Details
Trial ID
NCT05284539
Start Date
April 1 2022
End Date
October 10 2027
Last Update
June 7 2024
Active Locations (1)
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1
Hunan Cancer Hospital
Changsha, Hunan, China, 410013