RecruitingPhase 3NCT05922345

Evaluation of the Efficacy and Safety of AL2846 Capsule Combined With TQB2450 Injection Compared to Docetaxel Injection in Advanced Non-small Cell Lung Cancer Patients Who Have Failed With Immunotherapy.

A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of AL2846 Capsules Combined With TQB2450 Injection Compared With Docetaxel Injection in Patients With Advanced Non-small Cell Lung Cancer Who Have Failed With Immunotherapy.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Enrollment

518 participants

Start Date

Jun 8, 2023

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

Summary

To investigate the efficacy of AL2846 capsules in combination with TQB2450 injection or Docetaxel injection in patients with advanced NSCLC who have previously failed immune checkpoint inhibitors (anti-PD-1 monoclonal antibody, anti-PD-L1 monoclonal antibody), regardless of new anti-tumor treatment and early termination of treatment.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing a new drug combination — AL2846 (a multi-targeted cancer growth inhibitor) plus TQB2450 (an immunotherapy drug) — against the standard second-line treatment, docetaxel chemotherapy, for people with advanced non-small cell lung cancer (NSCLC) whose cancer has stopped responding to both platinum chemotherapy and immunotherapy. **You may be eligible if:** - You are 18–75 years old, in reasonably good physical condition (ECOG 0–1), and have a normal body weight range (BMI at least 17) - You have advanced, locally advanced, or metastatic non-small cell lung cancer confirmed by biopsy - Your cancer has already failed both platinum-based chemotherapy and immune checkpoint inhibitor therapy - You have at least one measurable tumor on imaging - You have adequate organ function (blood, liver, kidneys) **You may NOT be eligible if:** - Your tumor has specific driver mutations (EGFR, ALK, ROS1) for which approved targeted drugs exist - You have a second active cancer - You have had major surgery or serious injury within the past 28 days - You have had blood clots or thrombotic events within the past 6 months - You have problems swallowing oral medications 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 injection, docetaxel injection matching placebo, AL2846 capsules

AL2846 capsules is a multi-targeted small molecule receptor tyrosine kinase inhibitor. TQB2450 Injection is an anti-programmed death-1 (PD-L1).

DRUGTQB2450 placebo, docetaxel injection, AL2846 matching placebo

Docetaxel injection is a type of chemotherapy for treatment of different types of cancer.