RecruitingPhase 2NCT06141226

Phase II Clinical Trial to Evaluate the Safety and Efficacy of TQB2450 Injection Combined With Anlotinib Capsule and Chemotherapy in the Treatment of Immunoresistant Advanced Non-small Cell Lung Cancer

Randomized, Double-blind, Parallel Controlled, Multicenter Phase II Clinical Trial to Evaluate the Safety and Efficacy of TQB2450 Injection Combined With Arotinib Capsules and Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer After Immune Resistance

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

148 participants

Start Date

Apr 12, 2023

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

Summary

Objective to compare the efficacy and safety of TQB2450 injection combined with anlotinib and chemotherapy, and TQB2450 injection combined with chemotherapy in the treatment of advanced non-small cell lung cancer subjects who failed to receive first-line chemotherapy combined with immunization, and to explore and evaluate biomarkers related to efficacy, mechanism of action / resistance mechanism, and safety.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 trial tests whether adding two targeted drugs — TQB2450 (an immune checkpoint inhibitor) and anlotinib (an anti-angiogenesis drug) — to chemotherapy can help people with advanced non-small cell lung cancer (NSCLC) that has stopped responding to prior immunotherapy. **You may be eligible if...** - You are between 18 and 75 years old - You have advanced (Stage IIIB/IIIC) or metastatic/recurrent (Stage IV) NSCLC confirmed by biopsy that cannot be surgically removed - Your overall health is good (ECOG 0 or 1) - Your life expectancy is at least 3 months - You have at least one measurable tumor on imaging - Your prior immunotherapy has stopped working **You may NOT be eligible if...** - You have not previously received immunotherapy for NSCLC - Your cancer is early stage or can be surgically removed - Your health is too poor to receive combination therapy - You do not meet organ function and blood count requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTQB2450 +Anlotinib+Docetaxel

TQB2450 is a humanized monoclonal antibody targeting programmed death ligand 1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on the surface of T cells, restoring T cell activity and enhancing immune response. It has the potential to treat various types of tumors. Anlotinib is a multi target receptor tyrosine kinase (RTK) inhibitor. It can inhibit VEGFR1, VEGFR2, VEGFR3, c-Kit, PDGFR β Activity. Docetaxel is a taxane based anti-tumor drug.

DRUGTQB2450 +Androtinib Placebo+Docetaxel

TQB2450 is a humanized monoclonal antibody targeting programmed death ligand 1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on the surface of T cells, restoring T cell activity and enhancing immune response. It has the potential to treat various types of tumors. Androtinib Placebo Docetaxel is a taxane based anti-tumor drug.

Locations(5)

The Central People's Hospital of Huizhou

Huizhou, Guangdong, China

The First Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, China

The Second People's Hospital of Lianyungang

Lianyungang, Jiangsu, China

Weihai Municipal Hospital

Weihai, Shandong, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06141226

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