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A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer

NCT05990127 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 642

Last updated 2023-08-14

No results posted yet for this study

Summary

This is a randomized, double-blind, phase III clinical study to compare the efficacy and safety of AK104 combined chemotherapy versus Tislelizumab combined chemotherapy in first-line treatment of Locally advanced or metastatic NSCLC with PD-L1 TPS \< 1%.

Conditions

  • Locally Advanced or Metastatic NSCLC

Interventions

DRUG

AK104

AK104 IV, q3w

DRUG

Tislelizumab

Tislelizumab IV, q3w

DRUG

carboplatin

carboplatin IV, q3w

DRUG

Pemetrexed

Pemetrexed IV, q3w (for Nonsquamous NSCLC)

DRUG

Paclitaxel

Paclitaxel IV, q3w (for squamous NSCLC)

Sponsors & Collaborators

Principal Investigators

  • Jie Wang, M.D. · Cancer hospital, Chinese academy of medical sciences and Peking union medical college

  • Qingming Wang · Henan Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-14
Primary Completion
2025-08-05
Completion
2026-11-28

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT05990127 on ClinicalTrials.gov