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Ociperlimab With Tislelizumab and Chemotherapy in Participants With Untreated Metastatic Non-Small Cell Lung Cancer

NCT05014815 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2025-09-16

Study results available
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Summary

This study aimed to evaluate the safety and effectiveness of ociperlimab combined with tislelizumab and chemotherapy, compared to tislelizumab and chemotherapy alone, in participants with non-small cell lung cancer (NSCLC) that was locally advanced, could not be removed by surgery, or had spread to other parts of the body.

Conditions

  • Locally Advanced, Unresectable, or Metastatic Nonsmall Cell Lung Cancer (NSCLC)
  • Nonsmall Cell Lung Cancer, Stage IIIB
  • Nonsmall Cell Lung Cancer, Stage IV

Interventions

DRUG

Ociperlimab

900 mg intravenously (IV) once every 3 weeks (Q3W)

DRUG

Tislelizumab

200 mg IV Q3W

DRUG

Carboplatin

Area under the concentration-time curve (AUC) of 5 or 6, administered on Day 1 of each 21-day cycle

DRUG

Paclitaxel

75 or 200 mg per square meter (mg/m²) of body surface area, administered on Day 1 of each 21-day cycle

DRUG

Nab paclitaxel

100 mg/m², administered intravenously on Days 1, 8, and 15 of each 21-day cycle

DRUG

Cisplatin

75 mg/m², administered intravenously on Day 1 of each 21-day cycle

DRUG

Pemetrexed

500 mg/m² administered intravenously on Day 1 of each 21-day cycle

DRUG

Placebo

Administered intravenously Q3W to match ociperlimab

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-16
Primary Completion
2024-09-04
Completion
2024-09-04
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • China
  • France
  • Greece
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT05014815 on ClinicalTrials.gov