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OncoMatch/Clinical Trials/NCT05266846

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

Is NCT05266846 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pembrolizumab for alk gene mutation.

Phase 2RecruitingHunan Province Tumor HospitalNCT05266846Data as of May 2026

Treatment: PembrolizumabThis 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.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: ALK rearrangement

ALK-rearranged Lung Adenocarcinoma

Required: ALK persistent 5'ALK

Persistent with 5'ALK

Disease stage

Required: Stage IV

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: ALK inhibitor (alectinib) — first line

Failed from first line Alectinib

Cannot have received: anti-PD-1 therapy

Prior treatment with anti-programmed death-1

Cannot have received: anti-PD-L1 therapy

Prior treatment with anti-PD-L1 therapeutic antibodies

Cannot have received: anti-VEGF therapy

Prior treatment with anti-VEGF agents

Lab requirements

Blood counts

Adequate hematologic function

Kidney function

Adequate end organ function

Liver function

Adequate end organ function

Adequate hematologic and end organ function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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