Status:
COMPLETED
Anti-PD-1 in Combination With Chemotherapy as First-Line Treatment to Lung Cancer
Lead Sponsor:
BeiGene
Conditions:
Locally Advanced Lung Cancer; Metastatic Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 w...
Eligibility Criteria
Inclusion
- Key
- Male or female, aged 18-75 years on the day of signing informed consent.
- Have histologically or cytologically confirmed locally advanced or metastatic non-squamous NSCLC, squamous NSCLC, or extensive-stage SCLC.
- Note: Participants with mixed adenosquamous carcinoma may also be enrolled on a case-by-case basis after discussion with the medical monitors.
- Have had no prior systemic therapy for advanced or metastatic disease. Prior neoadjuvant/adjuvant therapy or chemoradiation therapy with curative intent should have been completed at least 6 months prior to documentation of recurrence of disease.
- Participants must be able to provide fresh or archival tumor tissues (formalin-fixed paraffin-embedded \[FFPE\] blocks or at least 10 unstained FFPE slides) with an associated pathological report.
- Key
Exclusion
- Participants with a sensitizing mutation in EGFR gene or an ALK fusion oncogene (specifically for participants with non- squamous NSCLC). Participants with unknown mutation/fusion status of EGFR and/or ALK must take the respective test at the investigational sites (or other designated sites) prior to enrolment.
- Prior malignancy active within the previous 2 years exceptions include the tumor under investigation in this trial, and locally recurring cancers that have undergone curative treatment, such as resected basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast
- Prior therapies targeting PD-1, PD-L1 or PD-L2
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
August 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2020
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03432598
Start Date
August 24 2017
End Date
December 21 2020
Last Update
October 23 2024
Active Locations (7)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
2
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
3
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 101149
4
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000