A Study Tislelizumab in Combination With Chemotherapy Versus Chemotherapy in Advanced Lung Cancer.

• Status: Active, not recruiting
• Trial end date: 2022-07-20
• Target enrollment: 0
• Participant gender: All

Summary

An open-label, randomized, multicenter Phase 3 study designed to compare the efficacy and safety of Tislelizumab combined with chemotherapy versus chemotherapy only as first-line treatment in advanced Squamous NSCLC. 45 sites will be involved in China, 342 participants will be enrolled.

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

Details

• Lead Sponsor: BeiGene
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

Key Inclusion Criteria:

1. Age 18-75 years old, male or female, signed informed consent form (ICF).

2. Advanced NSCLC diagnosed by pathological or clinical physicians

3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1

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

5. Must be treatment-naive for locally advanced or metastatic 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

Key Exclusion Criteria:

1. Diagnosed with NSCLC but with epidermal growth factor receptors (EGFR)-sensitizing mutation or ALK gene translocation

2. Received any approved systemic anticancer therapy

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

6. Clinically significant pericardial effusion

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

8. Any major surgical procedure before randomization

9. HIV infection

10. Participant with untreated hepatitis B virus (HBV)/hepatitis C virus (HCV)

11. Active autoimmune diseases or history of autoimmune diseases

12. History of allergic reactions to chemotherapy

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.