A Study Evaluating the Efficacy and Safety of Tislelizumab Versus Chemotherapy in Advanced Non-Squamous NSCLC

• Status: Active, not recruiting
• Trial end date: 2022-01-30
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 3, Open-Label, Multi-Center, Randomized Study to Investigate the Efficacy and Safety of Tislelizumab (BGB-A317) (Anti-PD1 Antibody) Combined With Platinum-Pemetrexed Versus Platinum-Pemetrexed Alone as First-line Treatment for Participants With Stage IIIB or IV Non-Squamous Non-Small Cell Lung Cancer. 45 sites will be involved in China, 320 subjects will be enrolled.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene
• Treatments: Carboplatin; Cisplatin; Pemetrexed

Criteria

Inclusion Criteria:

1. Age 18-75 years old, male or female, signed ICF.

2. Advanced NSCLC diagnosed by pathological or clinical physicians

3. ECOG PS ≤ 1

4. Participants must have ≥ 1 measurable lesion as defined per RECIST v1.1

5. Participants must have no prior systemic chemotherapy for advanced or metastatic Non-Squamous NSCLC

6. Life expectancy ≥ 12 weeks

7. Participants must have adequate organ function

8. Male/Female is willing to use a highly effective method of birth control …….

Exclusion Criteria:

1. Diagnosed with NSCLC but with EGFR-sensitizing mutation or ALK gene translocation

2. Received any approved systemic anticancer therapy within 28 days prior to the initiation of study treatment

3. Received prior treatment with EGFR inhibitors or ALK inhibitors

4. Received prior therapies targeting PD-1 or PD-L1

5. With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases

6. Clinically significant pericardial effusion

7. Sever infections, Active leptomeningeal disease or uncontrolled, untreated brain metastasis

8. Any major surgical procedure ≤ 28 days before randomization

9. HIV infection

10. Participants with untreated HBV/HCV.

11. Active autoimmune diseases or history of autoimmune diseases

12. History of allergic reactions to chemotherapy ……..