NCT03432598

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

A Phase II, Open-Label, Multi-Cohort Study to Investigate the Preliminary Antitumor Activity, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Combination With Chemotherapy as First-Line Treatment in Chinese Subjects With Locally Advanced or Metastatic Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2017-08-24
• Primary completion: 2019-02-25
• Completion: 2020-12-21
• First posted: 2018-02-14
• Last updated: 2024-10-23

Locations

7 sites across 1 country: China