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.

CTTQ

Status and phase: Enrolling; Phase 3

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: TQB2450 placebo, docetaxel injection, AL2846 matching placebo; Drug: TQB2450 injection, docetaxel injection matching placebo, AL2846 capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT05922345

TQB2450-AL2846-III-01

Details and patient eligibility

About

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.

Enrollment: 518 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 Have been diagnosed or currently had other malignant tumors;
• Presence of epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion, c-ros oncogene 1 (ROS1) fusion and other significant driver gene mutations;
• Factors affecting oral drugs;
• Major surgical treatment, incisional biopsy or obvious traumatic injury and long-term uncured wound or fracture within 28 days before the start of study treatment;
• Hyperactive/venous thrombotic events within 6 months;
• Subjects with any severe and/or uncontrolled disease;
• Previously received other immunotherapy and Research Advance of Small Molecular Targeted Anti-Tumor Agents Tyrosine kinase inhibitors (TKIs);
• According to the investigator's judgment, there are concomitant diseases that seriously endanger the subject's safety or affect the completion of the study, or there are other reasons that are not suitable for the subject;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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518 participants in 2 patient groups

TQB2450 injection + docetaxel injection matching placebo + AL2846 capsules

Experimental group

Description:

TQB2450 injection combined with docetaxel injection matching placebo and AL2846 capsules 21 days as a treatment cycle.

Treatment:

Drug: TQB2450 injection, docetaxel injection matching placebo, AL2846 capsules

TQB2450 placebo + docetaxel injection + AL2846 placebo

Active Comparator group

Description:

TQB2450 placebo combined with docetaxel injection and AL2846 placebo 21 days as a treatment cycle.

Treatment:

Drug: TQB2450 placebo, docetaxel injection, AL2846 matching placebo