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Recruiting Phase 3 NCT05922345

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.

Trial Parameters

Condition Non-small Cell Lung Cancer
Sponsor Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 518
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2023-06-08
Completion 2025-08
Interventions
TQB2450 injection, docetaxel injection matching placebo, AL2846 capsulesTQB2450 placebo, docetaxel injection, AL2846 matching placebo

Brief 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 Criteria

Inclusion Criteria: * The subjects voluntarily joined the study, signed an informed consent form, and had good compliance * Age: 18-75 years; Eastern Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-1; BMI ≥ 17 at baseline; * Patients with histologically or cytologically confirmed inoperable and inoperable locally advanced (stage IIIB/IIIC), metastatic or recurrent (stage IV) nonsmall-cell lung cancer (NSCLC) who cannot receive radical concurrent chemoradiotherapy; * Failure of platinum-based chemotherapy and immune checkpoint inhibitors for incurable locally advanced or metastatic or recurrent NSCLC; * Number of lines of prior systemic therapy received for locally advanced or metastatic/recurrent disease that is unresectable/not amenable to radical chemoradiation; * Confirmed to have at least one measurable lesion according to Response Evaluation Criteria In Solid Tumours( RECIST 1.1) standard; * Adequate major organ function; Exclusion Criteria: * Patients who

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