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Clinical Trials in China / NCT05284539
Recruiting Phase 2

Efficacy of Platinum-based Chemotherapy Plus Immune Checkpoint Inhibitors for EGFR/ALK/ROS1 Mutant Lung Cancer

NCT05284539 · tracked via the Priya Life Science China tracker
Sponsor
Hunan Province Tumor Hospital
Phase
Phase 2
Started
2022-04-01
Last updated
2024-06-07

Condition(s) studied

Non Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Pemetrexed, Cisplatin, Bevacizumab Plus Pembrolizumab →

Pemetrexed, Cisplatin, Bevacizumab Plus Pembrolizumab: Pemetrexed, 500mg/m2, ivgtt, every 21 days. Bevacizumab 15mg/kg, ivgtt, every 21 days. Pembrolizumab, 200mg ivgtt, every 21 days. Atezolizumab, 1200mg, ivgtt, every 21 days.

Study 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 Standard Treatment.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form. 2. Age ≥ 18 years. 3. Histologically or cytologically confirmed, Stage IV NSCLC. 4. EGFR/ALK/ROS1-sensitive mutations confirmed by an accredited local laboratory, progressed from first line systematic therapy. 5. ECOG 0-1. 6. Predicted survival ≥ 12 weeks. 7. Adequate bone marrow hematopoiesis and organ function 8. Presence of measurable lesions according to RECIST 1.1. Exclusion Criteria: 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hunan Cancer Hospital Changsha Hunan Recruiting

More Hunan Province Tumor Hospital trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05284539 on ClinicalTrials.gov ↗ ← All trials in China