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.
1 other identifier
interventional
518
1 country
71
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 nonsmall-cell-lung-cancer
Started Jun 2023
Shorter than P25 for phase_3 nonsmall-cell-lung-cancer
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2023
CompletedStudy Start
First participant enrolled
June 8, 2023
CompletedFirst Posted
Study publicly available on registry
June 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedDecember 30, 2024
June 1, 2024
2.2 years
June 6, 2023
December 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival (OS)
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 Outcomes (18)
Progression-free survival (PFS) by investigator assessment
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 from the date of randomization to the first recorded complete remission (CR) or partial remission (PR), assessed up to 36 months.
Disease Control Rate (DCR)
Time from randomization date to CR, PR, or SD or 6 weeks, whichever came first.
Duration of response (DOR)
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)
Baseline up to 12-month
- +13 more secondary outcomes
Study Arms (2)
TQB2450 injection + docetaxel injection matching placebo + AL2846 capsules
EXPERIMENTALTQB2450 injection combined with docetaxel injection matching placebo and AL2846 capsules 21 days as a treatment cycle.
TQB2450 placebo + docetaxel injection + AL2846 placebo
ACTIVE COMPARATORTQB2450 placebo combined with docetaxel injection and AL2846 placebo 21 days as a treatment cycle.
Interventions
AL2846 capsules is a multi-targeted small molecule receptor tyrosine kinase inhibitor. TQB2450 Injection is an anti-programmed death-1 (PD-L1).
Docetaxel injection is a type of chemotherapy for treatment of different types of cancer.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (71)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230001, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing Municipality, 100070, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100080, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Beijing Chest Hospital Capital Medical University
Beijing, Beijing Municipality, 101149, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Three Gorges Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality, 404100, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350014, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361001, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050, China
Meizhou People's Hospital
Meizhou, Guangdong, 514031, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515000, China
Zhongshan City People's Hospital
Zhongshan, Guangdong, 528403, China
Guigang people's hospital
Guigang, Guangxi, 537100, China
Liuzhou people's hospital
Liuchow, Guangxi, 545006, China
Guangxi Medical University Afiliated Tomor Hospital
Nanning, Guangxi, 530021, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002, China
The Second Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563006, China
The Second Affiliated Hospital of Hainan Medical College
Haikou, Hainan, 570216, China
Hainan Provincial People's Hospital
Haikou, Hainan, 570311, China
Affiliated Hospital of Hebei University
Baoding, Hebei, 71000, China
Affiliated Hospital of Chengde Medical College
Chengde, Hebei, 67020, China
Tangshan People's Hospital
Tangshan, Hebei, 63001, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163316, China
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081, China
Jiamusi Tuberculosis Hospital (Jiamusi Cancer Hospital)
Jiamusi, Heilongjiang, 154007, China
Tong Ji Hospital Affiliated To Tongji Medical College HUST
Wuhan, Hubei, 430030, China
Hubei Cancer Hospital (HBCH)
Wuhan, Hubei, 430079, China
Xiangyang Central Hospital
Xiangyang, Hubei, 441021, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
Hunan Cancer Hospital
Changsha, Hunan, 410031, China
Hunan Cancer Hospital
Changsha, Hunan, 410031, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 17000, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009, China
Nantong Tumor Hospital
Nantong, Jiangsu, 226361, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221002, China
XuZhou Central Hospital
Xuzhou, Jiangsu, 221009, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Shenyang Tenth People'S Hospital
Shenyang, Liaoning, 110096, China
The Second Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, 710004, China
The First Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, 710032, China
The Second Affiliated Hospital of the Military Medical University of the PLA Air Force
Xi'an, Shaanxi, 710038, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Binzhou Medical University Hospital
Binzhou, Shandong, 256600, China
Heze Municipal Hospital
Heze, Shandong, 274000, China
The Second Hospital of Shandong University
Jinan, Shandong, 250000, China
Shandong Cancer Hospital&Institute
Jinan, Shandong, 250117, China
Affiliated Hospital of Jining Medical Uniwersity
Jining, Shandong, 272000, China
Linyi Cancer Hospital
Linyi, Shandong, 276001, China
Linyi People's Hospital
Linyi, Shandong, 276005, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266071, China
Changzhi People'S Hospital
Changzhi, Shanxi, 46000, China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, 46000, China
Linfen Central Hospital
Linfen, Shanxi, 41000, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 30000, China
Affiliated Hospital of North SIchuan Medical College
Nanchong, Sichuan, 637000, China
The second people's hospital of neijiang
Neijiang, Sichuan, 641199, China
TianJin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300222, China
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650106, China
The First Affliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310018, China
Taizhou Enze Medical Center (Group)
Taizhou, Zhejiang, 318000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2023
First Posted
June 28, 2023
Study Start
June 8, 2023
Primary Completion
August 1, 2025
Study Completion
December 1, 2025
Last Updated
December 30, 2024
Record last verified: 2024-06