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

Recruiting now · Phase 2

Conditions studied: Non Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT05284539

Run by

Hunan Province Tumor Hospital

People needed

760

Starts

2022-04-01

Expected to finish

2027-10-10

Last updated by the study team

2024-06-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hunan Cancer Hospital — Changsha, Hunan, China (enrolling)

Full record on ClinicalTrials.gov

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