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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.

Last Updated: 2024-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

518 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-08

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TQB2450 injection + docetaxel injection matching placebo + AL2846 capsules

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

Group Type EXPERIMENTAL

TQB2450 injection, docetaxel injection matching placebo, AL2846 capsules

Intervention Type DRUG

AL2846 capsules is a multi-targeted small molecule receptor tyrosine kinase inhibitor.

TQB2450 Injection is an anti-programmed death-1 (PD-L1).

TQB2450 placebo + docetaxel injection + AL2846 placebo

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

Group Type ACTIVE_COMPARATOR

TQB2450 placebo, docetaxel injection, AL2846 matching placebo

Intervention Type DRUG

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

Interventions

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TQB2450 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).

Intervention Type DRUG

TQB2450 placebo, docetaxel injection, AL2846 matching placebo

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

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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