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Spots Global Cancer Trial Database for Anti-PD-1 in Combination With Chemotherapy as First-Line Treatment to Lung Cancer

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We do not endorse or review these studies in any way.

Trial Identification

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

Official Title: 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

Study ID: NCT03432598

Study Description

Brief 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.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Chinese Academy of Medical Sciences Tumor Hospital, Beijing, Beijing, China

Beijing Cancer Hospital, Beijing, Beijing, China

Beijing Chest Hospital, Beijing, Beijing, China

Henan Cancer Hospital, Zhengzhou, Henan, China

Jaingsu People's Hospital, Nanjing, Jiangsu, China

Jilin University First Hospital, Changchun, Jilin, China

Jilin Cancer Hospital, Changchun, Jilin, China

Contact Details

Name: Jie Wang, MD

Affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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