RecruitingPhase 2NCT05266846

Pembrolizumab Plus Bevacizumab and Chemotherapy for ALK-rearranged NSCLC With Persistent 5'ALK

Bevacizumab and Chemotherapy With or Without Pembrolizumab in First Line Alectinib Failed ALK-rearranged Advanced Lung Adenocarcinoma Patients With Persistent 5'ALK: A Phase II Randmized Control Trial

Sponsor

Hunan Province Tumor Hospital

Enrollment

78 participants

Start Date

May 29, 2024

Study Type

INTERVENTIONAL

Conditions

Lung Adenocarcinoma Immunotherapy ALK Gene Mutation

Summary

This is an open-label, multiple centers, two-arms phase II study to evaluate the safety and efficacy Pembrolizumab,Bevacizumab in combination with Chemotherapy could improve PFS in Alectinib Failed ALK-rearranged Advanced Lung Adenocarcinoma with Persistent 5'ALK. The eligible patients should have Stage IV Adenocarcinoma ALK-rearranged tested by NGS Perisitent with 5'ALK Failed from first line Alectinib. The patients should meet the physical requirements to receive Pembrolizumab, Bevacizumab with Chemotherapy. All the patients who meet these requirements will be enrolled in this study. The eligible patients will be treated with Pembrolizumab 200 mg intravenously (IV) plus Bevacizumab 15mg/kg+ Pemetrexed 500mg/m2+Carboplatin AUC=4 for up to 4 cycles followed by Pembrolizumab 200mg Q3W+ Bevacizumab 15mg/kg+Pemetrexed 500mg/m2 for up to 31cycles or until disease progression, intolerable toxicity, or physician or participant decision.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of immunotherapy (pembrolizumab), anti-angiogenic therapy (bevacizumab), and chemotherapy for people with stage IV ALK-rearranged lung cancer whose cancer has progressed on first-line treatment with a drug called alectinib and who have a specific genetic change called 5' ALK. **You may be eligible if...** - You are 18 years or older - You have Stage IV lung adenocarcinoma with an ALK gene rearrangement - Your cancer has progressed after treatment with alectinib - Your tumor has the specific '5' ALK' change detected by molecular testing - You have at least one measurable tumor lesion - You have tumor tissue available for testing (or are willing to provide a new biopsy) - You are in generally good physical condition (ECOG 0 or 1) **You may NOT be eligible if...** - You have not previously received alectinib - You have active autoimmune disease or are on steroids - You have serious bleeding or clotting history - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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