BEYONDNCT05266846

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

StatusRecruiting

PhasePhase 2

SponsorHunan Province Tumor Hospital

Primary completionNov 16, 2026 (estimated)

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Record History

All 11 versions: 10 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

Notable May 28, 2024 Trial status: Not Yet Recruiting to Recruitingv11 Show 8 more changesShow less
- Enrollment target: 30 to 78
- Primary completion date: Nov 16, 2024 to Nov 16, 2026
- Start date changed from estimate of Jan 20, 2024 to May 29, 2024
- Study completion date: Feb 16, 2025 to Feb 16, 2027
- Interventions: Pembrolizumab Combined With Bevacizumab and Chemotherapy (Drug) to Pembrolizumab injection (Drug)
- Study description expanded, about 85 words
- Site details revised
- Study arms: 1 to 2
Notable Dec 25, 2023 Primary completion date: Nov 16, 2023 to Nov 16, 2024
- Start date: Oct 20, 2023 to Jan 20, 2024
- Study completion date: Feb 16, 2024 to Feb 16, 2025
v10
Notable Sep 8, 2023 Start date: Mar 20, 2023 to Oct 20, 2023v9
Notable Feb 28, 2023 Primary completion date: Feb 16, 2023 to Nov 16, 2023
- Start date: Jan 20, 2023 to Mar 20, 2023
v8
Notable Dec 26, 2022 Start date: Sep 20, 2022 to Jan 20, 2023v7

Show 4 earlier versionsHide 4 earlier versions

Notable Sep 11, 2022 Start date: Aug 1, 2022 to Sep 20, 2022v6
Notable Jul 14, 2022 Start date: Jun 1, 2022 to Aug 1, 2022v5
Notable May 13, 2022 Start date: Apr 20, 2022 to Jun 1, 2022v4
Notable Apr 10, 2022 Start date: Mar 16, 2022 to Apr 20, 2022v3

Mar 1, 2022 Study First Submitted

Notable: the plan changed

Endpoints

Primary

PFS

Timeframe: 2 years

Secondary (2)

ORR

DCR

Arms and interventions

Pembrolizumab plus Bevacizumab and ChemotherapyExperimental

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

Bevacizumab plus ChemotherapyExperimental

Bevacizumab plus Chemotherapy was used for ALK-rearranged NSCLC With Persistent 5'ALK.

Drugs: Pembrolizumab injection

Sites

1 site in 1 country

Hunan Cancer HospitalChangsha, Hunan, China

About this trial

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.

Trial details

Enrollment: 78 participants (estimated)
Started: May 29, 2024
Study completion: Feb 16, 2027 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Interventional, randomized, open label, treatment
Conditions: Adenocarcinoma of Lung, ALK Gene Mutation, Lung Adenocarcinoma, Immunotherapy
Official title: 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
First posted: Mar 4, 2022
Registry updated: May 30, 2024
Last verified: May 2024

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