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.

Status: Recruiting
Location: See all (71) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
China
Affiliated Hospital of Hebei University
NOT_YET_RECRUITING
Baoding
Beijing Cancer Hospital
NOT_YET_RECRUITING
Beijing
Beijing Chest Hospital Capital Medical University
NOT_YET_RECRUITING
Beijing
Beijing Friendship Hospital, Capital Medical University
NOT_YET_RECRUITING
Beijing
Beijing Tiantan Hospital Capital Medical University
NOT_YET_RECRUITING
Beijing
Cancer Hospital Chinese Academy of Medical Sciences
NOT_YET_RECRUITING
Beijing
Chinese PLA General Hospital
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
Binzhou Medical University Hospital
NOT_YET_RECRUITING
Binzhou
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
The Second Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
The Third Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Changzhi People'S Hospital
NOT_YET_RECRUITING
Changzhi
Heping Hospital Affiliated to Changzhi Medical College
NOT_YET_RECRUITING
Changzhi
Affiliated Hospital of Chengde Medical College
NOT_YET_RECRUITING
Chengde
Chongqing University Cancer Hospital
NOT_YET_RECRUITING
Chongqing
The First Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
Three Gorges Hospital Affiliated to Chongqing University
NOT_YET_RECRUITING
Chongqing
Daqing Oilfield General Hospital
NOT_YET_RECRUITING
Daqing
Fujian Provincial Cancer Hospital
NOT_YET_RECRUITING
Fuzhou
Guigang people's hospital
NOT_YET_RECRUITING
Guigang
Guizhou Provincial People's Hospital
NOT_YET_RECRUITING
Guiyang
Hainan Provincial People's Hospital
NOT_YET_RECRUITING
Haikou
The Second Affiliated Hospital of Hainan Medical College
NOT_YET_RECRUITING
Haikou
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
The First Affliated Hospital Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
Affiliated Cancer Hospital of Harbin Medical University
NOT_YET_RECRUITING
Harbin
The First Affiliated Hospital of Anhui Medical University
NOT_YET_RECRUITING
Hefei
Heze Municipal Hospital
NOT_YET_RECRUITING
Heze
The Affiliated Hospital of Inner Mongolia Medical University
NOT_YET_RECRUITING
Hohhot
Jiamusi Tuberculosis Hospital (Jiamusi Cancer Hospital)
NOT_YET_RECRUITING
Jiamusi
Shandong Cancer Hospital&Institute
NOT_YET_RECRUITING
Jinan
The Second Hospital of Shandong University
NOT_YET_RECRUITING
Jinan
Affiliated Hospital of Jining Medical Uniwersity
NOT_YET_RECRUITING
Jining
Yunnan Cancer Hospital
NOT_YET_RECRUITING
Kunming
Gansu Provincial Cancer Hospital
NOT_YET_RECRUITING
Lanzhou
Lanzhou University Second Hospital
NOT_YET_RECRUITING
Lanzhou
Linfen Central Hospital
NOT_YET_RECRUITING
Linfen
Linyi Cancer Hospital
NOT_YET_RECRUITING
Linyi
Linyi People's Hospital
NOT_YET_RECRUITING
Linyi
Liuzhou people's hospital
NOT_YET_RECRUITING
Liuzhou
Meizhou People's Hospital
NOT_YET_RECRUITING
Meizhou
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Affiliated Hospital of North SIchuan Medical College
NOT_YET_RECRUITING
Nanchong
Jiangsu Cancer Hospital
NOT_YET_RECRUITING
Nanjing
Guangxi Medical University Afiliated Tomor Hospital
NOT_YET_RECRUITING
Nanning
Nantong Tumor Hospital
NOT_YET_RECRUITING
Nantong
The second people's hospital of neijiang
NOT_YET_RECRUITING
Neijiang
The Affiliated Hospital of Qingdao University
NOT_YET_RECRUITING
Qingdao
Cancer Hospital of Shantou University Medical College
NOT_YET_RECRUITING
Shantou
Shenyang Tenth People'S Hospital
NOT_YET_RECRUITING
Shenyang
The First Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
Shanxi Provincial Cancer Hospital
NOT_YET_RECRUITING
Taiyuan
Taizhou Enze Medical Center (Group)
NOT_YET_RECRUITING
Taizhou
Tangshan People's Hospital
NOT_YET_RECRUITING
Tangshan
Tianjin Chest Hospital
NOT_YET_RECRUITING
Tianjin
TianJin Medical University Cancer Institute & Hospital
RECRUITING
Tianjin
Affiliated Tumor Hospital of Xinjiang Medical University
NOT_YET_RECRUITING
Ürümqi
Hubei Cancer Hospital (HBCH)
NOT_YET_RECRUITING
Wuhan
Tong Ji Hospital Affiliated To Tongji Medical College HUST
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of Air Force Medical University
NOT_YET_RECRUITING
Xi'an
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
The Second Affiliated Hospital of the Military Medical University of the PLA Air Force
NOT_YET_RECRUITING
Xi'an
The Second Affiliated Hospital of Xi 'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING
Xiamen
Xiangyang Central Hospital
NOT_YET_RECRUITING
Xiangyang
The Affiliated Hospital of Xuzhou Medical University
NOT_YET_RECRUITING
Xuzhou
XuZhou Central Hospital
NOT_YET_RECRUITING
Xuzhou
Zhongshan City People's Hospital
NOT_YET_RECRUITING
Zhongshan
The Second Affiliated Hospital of Zunyi Medical University
NOT_YET_RECRUITING
Zunyi
Contact Information
Primary
Dingzhi Huang, Doctor
dingzhi72@163.com
18622221232
Backup
Yi Hu, Doctor
huyi0401@aliyun.com
13911031186
Time Frame
Start Date: 2023-06-08
Estimated Completion Date: 2025-12
Participants
Target number of participants: 518
Treatments
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.
Active_comparator: TQB2450 placebo + docetaxel injection + AL2846 placebo
TQB2450 placebo combined with docetaxel injection and AL2846 placebo 21 days as a treatment cycle.
Sponsors
Leads: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

This content was sourced from clinicaltrials.gov

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