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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.

NCT05791097 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2023-07-24

No results posted yet for this study

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%.

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Interventions

DRUG

Ociperlimab

Ociperlimab is a monoclonal antibody formulated for intravenous infusion. 900 mg of ociperlimab will be administered on Day 1 of each 21-day cycle

DRUG

Placebo

Placebo infusions will consist of a sterile, normal saline solution. Placebo will be administered on Day 1 of each 21-day cycle

DRUG

Tislelizumab

Tislelizumab is a monoclonal antibody formulated for intravenous infusion. 200 mg of tislelizumab will be administered on Day 1 of each 21-day cycle

DRUG

Pembrolizumab

Pembrolizumab is a monoclonal antibody formulated for intravenous infusion. 200 mg of pembrolizumab will be administered on Day 1 of each 21-day cycle

DRUG

Carboplatin

Carboplatin is a chemotherapy agent formulated for intravenous infusion. Carboplatin will be administered (AUC 6 mg/mL\*min) on Day 1 of each 21-day cycle

DRUG

Cisplatin

Cisplatin is a chemotherapy agent formulated for intravenous infusion. Cisplatin will be administered (75 mg/m\^2) on Day 1 of each 21-day cycle

DRUG

Pemetrexed

Pemetrexed is a chemotherapy agent formulated for intravenous infusion. Pemetrexed will be administered (500 mg/m\^2) on Day 1 of each 21-day cycle

DRUG

Paclitaxel

Paclitaxel is a chemotherapy agent formulated for intravenous infusion. Paclitaxel will be administered (200 mg/m\^2) on Day 1 of each 21-day cycle

DRUG

Nab-paclitaxel

Nab-paclitaxel is a chemotherapy agent formulated for intravenous infusion. Nab-paclitaxel will be administered (100 mg/m\^2) on Day 1, 8 and 15 of each 21-day cycle

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-28
Primary Completion
2027-12-24
Completion
2027-12-26
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05791097 on ClinicalTrials.gov