Tislelizumab
DrugAdministered 200 mg intravenously (IV) as specified in the treatment arm
Other names: BGB-A317
NCT Number: NCT03432598
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.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 2
Beijing Cancer Hospital, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Note: Participants with mixed adenosquamous carcinoma may also be enrolled on a case-by-case basis after discussion with the medical monitors.
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Administered 200 mg intravenously (IV) as specified in the treatment arm
Other names: BGB-A317
Administered 175 mg/m² IV as specified in the treatment arm
Administered 1250 mg/m² IV as specified in the treatment arm
Administered 100 mg/m2 IV as specified in the treatment arm
Administered 500 mg/m² IV as specified in the treatment arm
Administered 75 mg/m²/day IV as specified in the treatment arm
Administered AUC 5 as specified in the treatment arm
Time frame: Up to 4 years
Time frame: Up to 4 years
Time frame: Up to 4 years
Time frame: Up to 4 years
Time frame: Up to 4 years
Time frame: Up to 4 years
Time frame: Up to 4 years
Time frame: Up to 4 years
BeiGene
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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