Study of Efficacy and Safety of Ociperlimab in Combination With Tislelizumab and Platinum-based Doublet Chemotherapy as First-line Treatment for Participants With Locally Advanced or Metastatic NSCLC.

• Status: Not yet recruiting
• Trial end date: 2027-09-28
• Target enrollment: 0
• Participant gender: All

Summary

The primary scientific question of interest is whether the addition of ociperlimab to platinum-based chemotherapy and tislelizumab improve progression-free survival (PFS) or overall survival (OS) compared to pembrolizumab and platinum-based chemotherapy as first-line therapy for participants with locally advanced or metastatic squamous or non-squamous NSCLC with PD-L1 expression of ≥1%.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel; Pembrolizumab; Pemetrexed

Criteria

Key Inclusion Criteria:

• Histologically confirmed locally advanced (stage IIIb/IIIc not eligible for definitive chemoradiation, radiation or surgery) or metastatic (stage IV) NSCLC (according to AJCC: Cancer Staging Manual, 8th edition) participants with no previous systemic treatment for advanced disease.

• Known PD-L1 status determined, prior to study randomization

• At least one measurable lesion as defined by RECIST 1.1 according to local radiology assessment at screening.

• ECOG performance status ≤1.

Key Exclusion Criteria:

• Active autoimmune diseases requiring treatment with steroids or immunosuppressors in the past 2 years prior to randomization.

• History of severe hypersensitivity reaction or any contraindication to ociperlimab, tislelizumab, pembrolizumab (or any other monoclonal antibodies), platinum containing drugs, nab-paclitaxel, paclitaxel, pemetrexed or any known excipients of these drugs.

• Participants with known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

• Participants with documented epidermal growth factor receptor (EGFR) sensitizing mutations, and/or ALK rearrangement assessed as part of the patients's standard of care by a validated test, as per local regulations will be excluded from the study.

• Participants with other known druggable molecular drivers (any histology) such as BRAF V600, KRASG12C, MET exon 14 mutations, NTRK, RET or ROS-1 rearrangement diagnosed per local tests who might be candidates for alternative targeted therapies as applicable per local regulations and treatment guidelines are excluded.

Other inclusion/exclusion criteria may apply