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Anti-PD-1 in Combination With Chemotherapy as First-Line Treatment to Lung Cancer

NCT03432598 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-10-23

No results posted yet for this study

Summary

This is a Phase II, open-label, 4-cohort study of the monoclonal antibody BGB-A317 in combination with standard platinum-based chemotherapy in participants with advanced NSCLC or SCLC. The 4 cohorts will be enrolled concurrently including non-squamous NSCLC Cohort, squamous NSCLC Cohort A, squamous NSCLC Cohort B and SCLC Cohort. Participants with a mixed adenocarcinoma and squamous cell NSCLC will be allocated to one of the NSCLC cohorts based on the predominant histopathological profile. (e.g., participants with adenocarcinoma component accounting for \> 50% will be allocated to non-squamous NSCLC cohort.). Participants with squamous NSCLC will be sequentially enrolled into either of the 2 squamous NSCLC cohorts by the trial stage i.e. the sequence of the enrollment for the squamous NSCLC cohorts will be as Cohort A safety run-in Stage, followed by Cohort B safety run-in Stage, Cohort A dose-expansion stage and Cohort B dose-expansion Stage.

Conditions

  • Locally Advanced Lung Cancer; Metastatic Lung Cancer

Interventions

DRUG

Tislelizumab

Administered 200 mg intravenously (IV) as specified in the treatment arm

DRUG

Paclitaxel

Administered 175 mg/m² IV as specified in the treatment arm

DRUG

Gemcitabine

Administered 1250 mg/m² IV as specified in the treatment arm

DRUG

Etoposide

Administered 100 mg/m2 IV as specified in the treatment arm

DRUG

Pemetrexed

Administered 500 mg/m² IV as specified in the treatment arm

DRUG

Cisplatin

Administered 75 mg/m²/day IV as specified in the treatment arm

DRUG

Carboplatin

Administered AUC 5 as specified in the treatment arm

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Principal Investigators

  • Jie Wang, MD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-24
Primary Completion
2019-02-25
Completion
2020-12-21

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03432598 on ClinicalTrials.gov