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. (AdvanTIG-306)

Novartis

Status and phase: Withdrawn; Phase 3

Conditions: Non-small Cell Lung Cancer (NSCLC)

Treatments: Drug: Carboplatin; Drug: Nab-paclitaxel; Drug: Pemetrexed; Drug: Cisplatin; Drug: Pembrolizumab; Drug: Paclitaxel; Drug: Placebo; Drug: Tislelizumab; Drug: Ociperlimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05791097

CWCD118A12301

2022-503098-12-00 (Other Identifier)

Details and patient eligibility

About

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%.

Full description

This is a randomized, double-blind, placebo controlled, multicenter, phase III study evaluating the 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 without actionable driver mutations.

Participants will receive study treatment every three weeks and will continue to receive it until RECIST 1.1 disease progression as determined by Investigator and confirmed by BIRC, unacceptable toxicity that precludes further treatment, treatment is discontinued at the discretion of the Investigator or participant, participant withdrawal of consent, pregnancy, lost to follow-up, or death.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

Arm A: Ociperlimab + tislelizumab + chemotherapy

Experimental group

Description:

Participants will receive ociperlimab in combination with tislelizumab and platinum-based doublet chemotherapy

Treatment:

Drug: Tislelizumab

Drug: Ociperlimab

Drug: Paclitaxel

Drug: Pemetrexed

Drug: Cisplatin

Drug: Nab-paclitaxel

Drug: Carboplatin

Arm B: Placebo + pembrolizumab + chemotherapy

Active Comparator group

Description:

Participants will receive ociperlimab placebo in combination with pembrolizumab and platinum-based doublet chemotherapy

Treatment:

Drug: Paclitaxel

Drug: Placebo

Drug: Pemetrexed

Drug: Cisplatin

Drug: Pembrolizumab

Drug: Nab-paclitaxel

Drug: Carboplatin

Arm C: Placebo + tislelizumab + chemotherapy

Placebo Comparator group

Description:

Participants will receive ociperlimab placebo in combination with tislelizumab and platinum-based doublet chemotherapy

Treatment:

Drug: Tislelizumab

Drug: Paclitaxel

Drug: Placebo

Drug: Pemetrexed

Drug: Cisplatin

Drug: Nab-paclitaxel

Drug: Carboplatin