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A Study of TQB2450 Injection Plus Chemotherapy Followed by TQB2450 Plus Anlotinib Versus Tislelizumab Plus Chemotherapy Followed by Tislelizumab in the Treatment of First-line Non-squamous Non-small Cell Lung Cancer(NSCLC).

NCT05346952 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2022-04-26

No results posted yet for this study

Summary

This is Phase 3, randomized, open-label, parallel controlled study designed to compare the efficacy and safety of TQB2450 in combination with platinum-containing chemotherapy followed by TQB2450 plus Anlotinib versus tislelizumab in combination with platinum-containing chemotherapy followed by tislelizumab in locally advanced (stage ⅢB/ⅢC), metastatic or recurrent ( Stage IV) non-squamous NSCLC cancer. The primary endpoint is Progression Free Survival (PFS) assessed by IRC.

Conditions

  • Advanced Non-squamous Non-small Cell Lung Cancer

Interventions

DRUG

TQB2450 injection, Tilelizumab injection, Anlotinib hydrochloride capsule, Pemetrexed disodium injection, Carboplatin injection

PD-L1(programmed cell death-Ligand 1) may be expressed on tumor cells and/or tumor-infiltrating immune cells, which can inhibit the anti-tumor immune response in the tumor microenvironment. On T cells and antigen-presenting cells, PD-L1 binding to PD-1 (programmed cell death-1) and B7.1 receptors inhibits cytotoxic T cell activation, T cell proliferation, and cytokine production.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-25
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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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 NCT05346952 on ClinicalTrials.gov