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.

December 25, 2024 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

518

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • Not yet recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
        • Contact:
      • Beijing, Beijing, China, 100021
        • Not yet recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
      • Beijing, Beijing, China, 100142
        • Not yet recruiting
        • Beijing Cancer Hospital
        • Contact:
      • Beijing, Beijing, China, 100050
        • Not yet recruiting
        • Beijing Friendship Hospital, Capital Medical University
        • Contact:
      • Beijing, Beijing, China, 100080
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:
      • Beijing, Beijing, China, 100070
        • Not yet recruiting
        • Beijing Tiantan Hospital Capital Medical University
        • Contact:
      • Beijing, Beijing, China, 101149
        • Not yet recruiting
        • Beijing Chest Hospital Capital Medical University
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 400030
        • Not yet recruiting
        • Chongqing University Cancer Hospital
        • Contact:
      • Chongqing, Chongqing, China, 400016
        • Not yet recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
      • Chongqing, Chongqing, China, 404100
        • Not yet recruiting
        • Three Gorges Hospital Affiliated to Chongqing University
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Not yet recruiting
        • Fujian Provincial Cancer Hospital
        • Contact:
      • Xiamen, Fujian, China, 361001
        • Not yet recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Not yet recruiting
        • Lanzhou University Second Hospital
        • Contact:
      • Lanzhou, Gansu, China, 730050
        • Not yet recruiting
        • Gansu Provincial Cancer Hospital
        • Contact:
    • Guangdong
      • Meizhou, Guangdong, China, 514031
        • Not yet recruiting
        • Meizhou People's Hospital
        • Contact:
      • Shantou, Guangdong, China, 515000
        • Not yet recruiting
        • Cancer Hospital of Shantou University Medical College
        • Contact:
      • Zhongshan, Guangdong, China, 528403
        • Not yet recruiting
        • Zhongshan City People's Hospital
        • Contact:
        • Contact:
    • Guangxi
      • Guigang, Guangxi, China, 537100
        • Not yet recruiting
        • Guigang People's Hospital
        • Contact:
          • Yan Wei, Master
          • Phone Number: 13321686622‬‬‬‬‬‬‬‬‬‬‬
          • Email: wyan184@163.com
        • Contact:
          • Jimei Feng, Master
          • Phone Number: 18934895538‬‬‬‬‬‬‬‬‬‬‬
          • Email: 1077143211@qq.com
      • Liuzhou, Guangxi, China, 545006
        • Not yet recruiting
        • Liuzhou People's Hospital
        • Contact:
      • Nanning, Guangxi, China, 530021
        • Not yet recruiting
        • Guangxi Medical University Afiliated Tomor Hospital
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China, 550002
        • Not yet recruiting
        • Guizhou Provincial People's Hospital
        • Contact:
      • Zunyi, Guizhou, China, 563006
        • Not yet recruiting
        • The Second Affiliated Hospital of Zunyi Medical University
        • Contact:
    • Hainan
      • Haikou, Hainan, China, 570311
        • Not yet recruiting
        • Hainan Provincial People's Hospital
        • Contact:
      • Haikou, Hainan, China, 570216
        • Not yet recruiting
        • The Second Affiliated Hospital of Hainan Medical College
        • Contact:
    • Hebei
      • Baoding, Hebei, China, 71000
        • Not yet recruiting
        • Affiliated Hospital of Hebei University
        • Contact:
      • Chengde, Hebei, China, 67020
        • Not yet recruiting
        • Affiliated Hospital of Chengde Medical College
        • Contact:
      • Tangshan, Hebei, China, 63001
        • Not yet recruiting
        • Tangshan People's Hospital
        • Contact:
    • Heilongjiang
      • Daqing, Heilongjiang, China, 163316
        • Not yet recruiting
        • Daqing Oilfield General hospital
        • Contact:
      • Harbin, Heilongjiang, China, 150081
        • Not yet recruiting
        • Affiliated Cancer Hospital of Harbin Medical University
        • Contact:
      • Jiamusi, Heilongjiang, China, 154007
        • Not yet recruiting
        • Jiamusi Tuberculosis Hospital (Jiamusi Cancer Hospital)
        • Contact:
          • Hongmei Sun, Bachelor
          • Phone Number: 15344540000
          • Email: shm357@163.com
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Not yet recruiting
        • Tong Ji Hospital Affiliated To Tongji Medical College HUST
        • Contact:
      • Wuhan, Hubei, China, 430079
        • Not yet recruiting
        • Hubei Cancer Hospital (HBCH)
        • Contact:
      • Xiangyang, Hubei, China, 441021
        • Not yet recruiting
        • Xiangyang Central Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410011
        • Not yet recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:
      • Changsha, Hunan, China, 410031
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
      • Changsha, Hunan, China, 410013
        • Not yet recruiting
        • The Third Xiangya Hospital of Central South University
        • Contact:
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 17000
        • Not yet recruiting
        • The Affiliated Hospital of Inner Mongolia Medical University
        • Contact:
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Not yet recruiting
        • Jiangsu Cancer Hospital
        • Contact:
      • Nantong, Jiangsu, China, 226361
        • Not yet recruiting
        • Nantong Tumor Hospital
        • Contact:
      • Xuzhou, Jiangsu, China, 221009
        • Not yet recruiting
        • Xuzhou Central Hospital
        • Contact:
      • Xuzhou, Jiangsu, China, 221002
        • Not yet recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Not yet recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Not yet recruiting
        • The First Hospital of China Medical University
        • Contact:
      • Shenyang, Liaoning, China, 110096
        • Not yet recruiting
        • Shenyang Tenth People's Hospital
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
      • Xi'an, Shaanxi, China, 710004
        • Not yet recruiting
        • The Second Affiliated Hospital of Xi 'an Jiaotong University
        • Contact:
      • Xi'an, Shaanxi, China, 710032
        • Not yet recruiting
        • The First Affiliated Hospital of Air Force Medical University
        • Contact:
      • Xi'an, Shaanxi, China, 710038
        • Not yet recruiting
        • The Second Affiliated Hospital of the Military Medical University of the PLA Air Force
        • Contact:
    • Shandong
      • Binzhou, Shandong, China, 256600
        • Not yet recruiting
        • Binzhou Medical University Hospital
        • Contact:
      • Heze, Shandong, China, 274000
        • Not yet recruiting
        • Heze Municipal Hospital
        • Contact:
      • Jinan, Shandong, China, 250000
        • Not yet recruiting
        • The Second Hospital of Shandong University
        • Contact:
      • Jinan, Shandong, China, 250117
        • Not yet recruiting
        • Shandong Cancer Hospital&Institute
        • Contact:
      • Jining, Shandong, China, 272000
        • Not yet recruiting
        • Affiliated Hospital of Jining Medical Uniwersity
        • Contact:
      • Linyi, Shandong, China, 276005
        • Not yet recruiting
        • Linyi People's Hospital
        • Contact:
      • Linyi, Shandong, China, 276001
        • Not yet recruiting
        • Linyi Cancer Hospital
        • Contact:
      • Qingdao, Shandong, China, 266071
        • Not yet recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:
    • Shanxi
      • Changzhi, Shanxi, China, 46000
        • Not yet recruiting
        • Changzhi People's Hospital
        • Contact:
        • Contact:
      • Changzhi, Shanxi, China, 46000
        • Not yet recruiting
        • Heping Hospital Affiliated to Changzhi Medical College
        • Contact:
      • Linfen, Shanxi, China, 41000
        • Not yet recruiting
        • Linfen Central Hospital
        • Contact:
      • Taiyuan, Shanxi, China, 30000
        • Not yet recruiting
        • Shanxi Provincial Cancer Hospital
        • Contact:
    • Sichuan
      • Nanchong, Sichuan, China, 637000
        • Not yet recruiting
        • Affiliated Hospital of North Sichuan Medical College
        • Contact:
          • Daiyuan Ma, Doctor
          • Phone Number: 13990889661
          • Email: mdylx@163.com
      • Neijiang, Sichuan, China, 641199
        • Not yet recruiting
        • The Second People's Hospital of Neijiang
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
      • Tianjin, Tianjin, China, 300222
        • Not yet recruiting
        • Tianjin Chest Hospital
        • Contact:
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Not yet recruiting
        • Affiliated Tumor Hospital of Xinjiang Medical University
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650106
        • Not yet recruiting
        • Yunnan Cancer Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Not yet recruiting
        • The First Affliated Hospital Zhejiang University School of Medicine
        • Contact:
      • Hangzhou, Zhejiang, China, 310018
        • Not yet recruiting
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
        • Contact:
      • Taizhou, Zhejiang, China, 318000
        • Not yet recruiting
        • Taizhou Enze Medical Center (group)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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).
Active Comparator: TQB2450 placebo + docetaxel injection + AL2846 placebo
TQB2450 placebo combined with docetaxel injection and AL2846 placebo 21 days as a treatment cycle.
Drug: TQB2450 placebo, docetaxel injection, AL2846 matching placebo
Docetaxel injection is a type of chemotherapy for treatment of different types of cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: From randomization to the time of death from any cause, assessed up to 36 months.
The time from randomization to the date of death from any cause.
From randomization to the time of death from any cause, assessed up to 36 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) by investigator assessment
Time Frame: From the date of randomization to the date of first recorded progression or death from any cause, whichever comes first, assessed up to 36 months.
Time from randomization to objective disease progression or death from any cause, whichever occurs first.
From the date of randomization to the date of first recorded progression or death from any cause, whichever comes first, assessed up to 36 months.
Objective response rate (ORR)
Time Frame: Time from the date of randomization to the first recorded complete remission (CR) or partial remission (PR), assessed up to 36 months.
Refers to the percentage of subjects with complete response (CR) or partial response (PR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
Time from the date of randomization to the first recorded complete remission (CR) or partial remission (PR), assessed up to 36 months.
Duration of response (DOR)
Time Frame: From the date of first documentation of tumor response to the date of first documentation of disease progression or death due to any cause, whichever occurs first, assessed up to 36 months.
For subjects with a best response of complete response (CR) or partial response (PR), it is defined as the time from the date of first documentation of tumor response to the date of first documentation of disease progression or death due to any cause, whichever occurs first.
From the date of first documentation of tumor response to the date of first documentation of disease progression or death due to any cause, whichever occurs first, assessed up to 36 months.
12-month survival rate (12-month OS rate)
Time Frame: Baseline up to 12-month
The survival curve corresponds to the cumulative survival rate at 12 months
Baseline up to 12-month
Health Questionnaire Form
Time Frame: During the screening period, the second cycle and other even numbered cycles, each cycle is 21 days, assessed up to 36 months.
Questionnaire: pain score：Place a check in the space that best reflects patients' health for the day.
During the screening period, the second cycle and other even numbered cycles, each cycle is 21 days, assessed up to 36 months.
Effects on subjects' health-related quality of life
Time Frame: During the screening period, the second cycle and other even numbered cycles, each cycle is 21 days, assessed up to 36 months.
Questionnaire: Quality of life related scale (The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 3rd edition).For questions 1 to 28, choose a number from 1 to 4, 1 means none and 4 means very good. For questions 29 and 30, choose a number from 1 to 7, with 1 being very poor and 7 being very good.
During the screening period, the second cycle and other even numbered cycles, each cycle is 21 days, assessed up to 36 months.
Patients with abnormal laboratory inspection indicators
Time Frame: From signing the informed consent form to the 30 days after the last dose.
Laboratory inspection indicators exceed the normal range
From signing the informed consent form to the 30 days after the last dose.
Adverse event rate
Time Frame: From signing the informed consent form to the 30 days after the last dose.
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
From signing the informed consent form to the 30 days after the last dose.
Occurrence of anti-drug antibody (ADA)
Time Frame: Pre-dose in cycle 1, cycle 2, cycle 5, cycle 9, 90 days after administration, each cycle is 21 days.
Occurrence of ADA immunoglobulin
Pre-dose in cycle 1, cycle 2, cycle 5, cycle 9, 90 days after administration, each cycle is 21 days.
Occurrence of neutralizing antibody (Nab)
Time Frame: Pre-dose in cycle 1, cycle 2, cycle 5, cycle 9, 90 days after administration, each cycle is 21 days.
Antibody preventing cells from being invaded by an antigen or infectious agent.
Pre-dose in cycle 1, cycle 2, cycle 5, cycle 9, 90 days after administration, each cycle is 21 days.
Disease Control Rate (DCR)
Time Frame: Time from randomization date to CR, PR, or SD or 6 weeks, whichever came first.
Refers to the percentage of subjects with complete response (CR), partial response (PR) or stable disease (SD) ≥ 6 weeks as determined by the investigator according to RECIST 1.1.
Time from randomization date to CR, PR, or SD or 6 weeks, whichever came first.
Peak Concentration (Cmax)
Time Frame: 60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days.
The highest plasma concentration of a drug reached after administration.
60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days.
Trough concentration (Cmin)
Time Frame: 60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days.
The lowest concentration of a drug at steady state after multiple doses.
60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days.
Peak time
Time Frame: 60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days.
The time it takes for a drug to reach Cmax.
60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days.
Area under the drug time curve (AUC)
Time Frame: 60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days.
The area under the curve of drug concentration in blood over time.
60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days.
Clearance
Time Frame: 60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days.
It represents the amount of drug cleared per unit of time, reflecting the body's ability to dispose of the drug.
60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days.
Apparent volume of distribution (Vd)
Time Frame: 60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days.
Describes the extent of drug distribution in the body.
60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days.
The elimination half-life (t1/2)
Time Frame: 60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days.
The time it takes for the drug concentration to drop to half of its original level.
60 minutes pre-dose on cycle 1 day 1, cycle 2 day 1, cycle 5 day 1, cycle 9 day 1; 10 minutes post dose on cycle 1 day 1, each cycle is 21 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2023

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

June 19, 2023

First Posted (Actual)

June 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 25, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQB2450-AL2846-III-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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