Non-small Cell Lung CancerPhase 3NCT05922345
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 Phase 3 study of Non-small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 71 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 518 participants
- Where
- 71 sitesChina
- Study dates
- 8 Jun 2023to Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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 locations and contacts
71 sites in 1 country.
71 sites in 1 country
China71 sites, 71 recruiting
- Not yet recruiting
Affiliated Hospital of Hebei University
Baoding, Hebei, 71000
Yanhong Shang, Master, 13930811186, Shangyanhong2013@163.com
- Not yet recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Yan Wang, Doctor, 13911793771, wangyanyifu@163.com
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Ligong Nie, Master, 13910714307, nieligong@sina.com
Shikai Wu, Doctor, 15810037307, skywu4923@sina.com
- Not yet recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Bangwei Cao, Doctor, 13021161027, daweicao@163.com
- Not yet recruiting
Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing Municipality, 100070
Xiaoyan Li, Doctor, 13466383808, sharerha@126.com
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100080
Yi Hu, Doctor, 13911031189, huyi0401@aliyun.com
- Not yet recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jun Zhao, Doctor, 13521469355, ohjerry@163.com
- Not yet recruiting
Beijing Chest Hospital Capital Medical University
Beijing, Beijing Municipality, 101149
Ying Hu, Doctor, 13681445657, huying@bjxkyy.cn
- Not yet recruiting
Binzhou Medical University Hospital
Binzhou, Shandong, 256600
Fangling Ning, Master, 15254311599, ningfangling@126.com
- Not yet recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Fang Ma, Doctor, 13975806788, doctor_fangma@126.com
- Not yet recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Xuewen Liu, Doctor, 18711033808, aveinliu@163.com
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410031
Yongzhong Luo, Bachelor, 13607443876, luoyongzhong@hnca.org.cn
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410031
Lin Wu, Doctor, 13170419973, wulin-calf@vip.163.com
- Not yet recruiting
Changzhi People'S Hospital
Changzhi, Shanxi, 46000
Jun Zhao, Doctor, 13835578500, zhaojun380@163.com
Xianping Zhao, Master, 13453503966, z13453503966@163.com
- Not yet recruiting
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, 46000
Junyan Yu, Doctor, 13720958692, hanbing398@163.com
- Not yet recruiting
Affiliated Hospital of Chengde Medical College
Chengde, Hebei, 67020
Qingshan Li, Bachelor, 15633142750, libing200865@126.com
- Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Yi Luo, Doctor, 15683265956, Littleroy@163.com
- Not yet recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Donglin Wang, Doctor, 13896188008, donglinw@21cn.com
- Not yet recruiting
Three Gorges Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality, 404100
Biyong Ren, Master, 13896327099, biyou@sina.com
- Not yet recruiting
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163316
Liangyu Zhang, Doctor, 13359812997, hdfi8d@sina.com
- Not yet recruiting
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350014
Haipeng Xu, Doctor, 13675007687, penghaixu@163.com
- Not yet recruiting
Guigang people's hospital
Guigang, Guangxi, 537100
Yan Wei, Master, 13321686622, wyan184@163.com
Jimei Feng, Master, 18934895538, 1077143211@qq.com
- Not yet recruiting
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002
Yingbo Xue, Master, 13984098959, 996050284@qq.com
- Not yet recruiting
The Second Affiliated Hospital of Hainan Medical College
Haikou, Hainan, 570216
Haifeng Lin, Bachelor, 13322060949, 13322060949@163.com
- Not yet recruiting
Hainan Provincial People's Hospital
Haikou, Hainan, 570311
Junmin Chen, Bachelor, 18889808030, 18889808030@139.com
- Not yet recruiting
The First Affliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Yulong Zheng, Doctor, 13588166206, drzhengyu@126.com
- Not yet recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310018
Yong Fang, Doctor, 13588491264, fyzju@sina.com
- Not yet recruiting
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081
Yan Yu, Doctor, 13904505825, gpyuyan@163.com
- Not yet recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230001
Yingying Du, Doctor, 13956012561, duyingying@126.com
- Not yet recruiting
Heze Municipal Hospital
Heze, Shandong, 274000
Xueru Cao, Master, 19963016996, cxrcaoxueru@163.com
- Not yet recruiting
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 17000
Junzhen Gao, Master, 13171099008, gaojunzhen202112@163.com
Qun Hu, Doctor, 13947167935, huqun2015@126.com
- Not yet recruiting
Jiamusi Tuberculosis Hospital (Jiamusi Cancer Hospital)
Jiamusi, Heilongjiang, 154007
Hongmei Sun, Bachelor, 15344540000, shm357@163.com
- Not yet recruiting
The Second Hospital of Shandong University
Jinan, Shandong, 250000
Haiqun Lin, Master, 17660085286, Linhaiqun@sina.com
- Not yet recruiting
Shandong Cancer Hospital&Institute
Jinan, Shandong, 250117
Haiyong Wang, Doctor, 15665878316, Wanghaiyong6688@126.com
- Not yet recruiting
Affiliated Hospital of Jining Medical Uniwersity
Jining, Shandong, 272000
Shucheng Ye, Master, 18678766862, 18678766862@163.com
- Not yet recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650106
Runxiang Yang, Master, 13888876721, 13888876721@163.com
- Not yet recruiting
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030
Bin Li, Master, 13919267218, wanyixin@yahoo.com.cn
- Not yet recruiting
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050
Lei Yang, Bachelor, 13909480531, yangleidoc@163.com
- Not yet recruiting
Linfen Central Hospital
Linfen, Shanxi, 41000
Dongfeng Zhang, Bachelor, 13835730068, 763799510@qq.com
- Not yet recruiting
Linyi Cancer Hospital
Linyi, Shandong, 276001
Jianhua Shi, Master, 15963998868, shijianhualy@126.com
- Not yet recruiting
Linyi People's Hospital
Linyi, Shandong, 276005
Guixiang Weng, Master, 15168965596, 15168965596@163.com
- Not yet recruiting
Liuzhou people's hospital
Liuzhou, Guangxi, 545006
Yanhua Jia, Master, 13633095654, 13633095654@163.com
- Not yet recruiting
Meizhou People's Hospital
Meizhou, Guangdong, 514031
Guowu Wu, Bachelor, 13823801920, wwwflay@126.com
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Longhua Sun, Doctor, 18279110112, 48570887@qq.com
- Not yet recruiting
Affiliated Hospital of North SIchuan Medical College
Nanchong, Sichuan, 637000
Daiyuan Ma, Doctor, 13990889661, mdylx@163.com
- Not yet recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Bo Shen, Doctor, 13913910555, shenbo@126.com
- Not yet recruiting
Guangxi Medical University Afiliated Tomor Hospital
Nanning, Guangxi, 530021
Aiping Zeng, Bachelor, 13877156330, zengaipingone@sina.com
- Not yet recruiting
Nantong Tumor Hospital
Nantong, Jiangsu, 226361
Xiaodong Zhang, Bachelor, 15051243672, 419317110@qq.com
- Not yet recruiting
The second people's hospital of neijiang
Neijiang, Sichuan, 641199
Ou Jiang, Doctor, 13990570757, jiangou816@163.com
- Not yet recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266071
Hongmei Li, Doctor, 18661800098, 18661800098@163.com
- Not yet recruiting
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515000
Hongbiao Wang, Master, 13715911174, wanghongbiao@qq.com
- Not yet recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Xiujuan Qu, Doctor, 13604031355, cmu1h_zlnk_trial@163.com
- Not yet recruiting
Shenyang Tenth People'S Hospital
Shenyang, Liaoning, 110096
Qiang Liu, Master, 18102486811, liuqiang8866@126.com
- Not yet recruiting
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 30000
Xia Song, Master, 13643518252, songxia76@hotmail.com
- Not yet recruiting
Taizhou Enze Medical Center (Group)
Taizhou, Zhejiang, 318000
Dongqing Lyv, Master, 13867622009, lvdq855@126.com
- Not yet recruiting
Tangshan People's Hospital
Tangshan, Hebei, 63001
Zhiwu Wang, Doctor, 18931506162, tcm2000@163.com
- Recruiting
TianJin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Dingzhi Huang, Doctor, 18622221232, dingzhi72@163.com
- Not yet recruiting
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300222
Jianwen Qin, Doctor, 13820521316, qinjianwen2005@aliyun.com
- Not yet recruiting
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000
Chunling Liu, Master, 13899931987, liudeyouxiang66@163.com
- Not yet recruiting
Tong Ji Hospital Affiliated To Tongji Medical College HUST
Wuhan, Hubei, 430030
Qian Chu, Doctor, 13212760751, qianchu@163.com
- Not yet recruiting
Hubei Cancer Hospital (HBCH)
Wuhan, Hubei, 430079
Bin Yang, Master, 13407192282, 245463239@qq.com
- Not yet recruiting
The Second Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, 710004
Shuanying Yang, Doctor, 13991392919, Yangshuanying66@163.com
- Not yet recruiting
The First Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, 710032
Hongmei Zhang, Doctor, 13991293309, zhm@fmmu.edu.cn
- Not yet recruiting
The Second Affiliated Hospital of the Military Medical University of the PLA Air Force
Xi'an, Shaanxi, 710038
Haichuan Su, Doctor, 18629190366, cntgcp@163.com
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Yu Yao, Doctor, 13572101611, 13572101611@163.com
- Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361001
Jingxun Wu, Master, 15160085395, 23889925@qq.com
- Not yet recruiting
Xiangyang Central Hospital
Xiangyang, Hubei, 441021
Tienan Yi, Master, 13871658799, 1721905183@qq.com
- Not yet recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221002
Zhengxiang Han, Doctor, 18052268612, hanzhengxiangxz@163.com
- Not yet recruiting
XuZhou Central Hospital
Xuzhou, Jiangsu, 221009
Xiang Wang, Master, 18912007930, wangxiang7726@163.com
- Not yet recruiting
Zhongshan City People's Hospital
Zhongshan, Guangdong, 528403
Junkai Zhang, Bachelor, 13600343123, jacob_zsrmyy@126.com
Minying Li, Doctor, 18948895629, hlkpjw@163.com
- Not yet recruiting
The Second Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563006
Yuju Bai, Master, 13984535566, BYJ6618@163.com
About this study
Official title: 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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- TQB2450 injection, docetaxel injection matching placebo, AL2846 capsules, TQB2450 placebo, docetaxel injection, AL2846 matching placebo
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2450 injection, docetaxel injection matching placebo, AL2846 capsulesDrug
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 matching placeboDrug
Docetaxel injection is a type of chemotherapy for treatment of different types of cancer.
| Study group | Role | What they receive |
|---|---|---|
| TQB2450 injection + docetaxel injection matching placebo + AL2846 capsules | Experimental | TQB2450 injection combined with docetaxel injection matching placebo and AL2846 capsules 21 days as a treatment cycle. Receives: Drug: TQB2450 injection, docetaxel injection matching placebo, AL2846 capsules |
| TQB2450 placebo + docetaxel injection + AL2846 placebo | Active comparator | TQB2450 placebo combined with docetaxel injection and AL2846 placebo 21 days as a treatment cycle. Receives: Drug: TQB2450 placebo, docetaxel injection, AL2846 matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
The time from randomization to the date of death from any cause.
Measured: 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
Time from randomization to objective disease progression or death from any cause, whichever occurs first.
Measured: 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)
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.
Measured: 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)
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.
Measured: Time from randomization date to CR, PR, or SD or 6 weeks, whichever came first.
Duration of response (DOR)
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.
Measured: 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)
The survival curve corresponds to the cumulative survival rate at 12 months
Measured: Baseline up to 12-month
Health Questionnaire Form
Questionnaire: pain score：Place a check in the space that best reflects patients' health for the day.
Measured: 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
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.
Measured: 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
Laboratory inspection indicators exceed the normal range
Measured: From signing the informed consent form to the 30 days after the last dose.
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Measured: From signing the informed consent form to the 30 days after the last dose.
Occurrence of anti-drug antibody (ADA)
Occurrence of ADA immunoglobulin
Measured: 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)
Antibody preventing cells from being invaded by an antigen or infectious agent.
Measured: Pre-dose in cycle 1, cycle 2, cycle 5, cycle 9, 90 days after administration, each cycle is 21 days.
Peak Concentration (Cmax)
The highest plasma concentration of a drug reached after administration.
Measured: 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)
The lowest concentration of a drug at steady state after multiple doses.
Measured: 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
The time it takes for a drug to reach Cmax.
Measured: 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)
The area under the curve of drug concentration in blood over time.
Measured: 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
It represents the amount of drug cleared per unit of time, reflecting the body's ability to dispose of the drug.
Measured: 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)
Describes the extent of drug distribution in the body.
Measured: 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)
The time it takes for the drug concentration to drop to half of its original level.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start8 Jun 2023
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 518 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922345
- Sponsor's protocol ID
- TQB2450-AL2846-III-01
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2023
- Last updated
- 30 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05922345
- Acronym / sponsor ID
- TQB2450-AL2846-III-01
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 518 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQB2450 injection + docetaxel injection matching placebo + AL2846 capsules | Experimental | Drug: TQB2450 injection, docetaxel injection matching placebo, AL2846 capsulesTQB2450 injection combined with docetaxel injection matching placebo and AL2846 capsules 21 days as a treatment cycle. |
| TQB2450 placebo + docetaxel injection + AL2846 placebo | Active comparator | Drug: TQB2450 placebo, docetaxel injection, AL2846 matching placeboTQB2450 placebo combined with docetaxel injection and AL2846 placebo 21 days as a treatment cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB2450 injection, docetaxel injection matching placebo, AL2846 capsulesAL2846 capsules is a multi-targeted small molecule receptor tyrosine kinase inhibitor. TQB2450 Injection is an anti-programmed death-1 (PD-L1). | Drug | TQB2450 injection + docetaxel injection matching placebo + AL2846 capsules |
| TQB2450 placebo, docetaxel injection, AL2846 matching placeboDocetaxel injection is a type of chemotherapy for treatment of different types of cancer. | Drug | TQB2450 placebo + docetaxel injection + AL2846 placebo |
Primary outcome
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.
18 secondary outcomes
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.
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.
Disease Control Rate (DCR)
Time frame: Time from randomization date to CR, PR, or SD or 6 weeks, whichever came first.
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.
12-month survival rate (12-month OS rate)
Time frame: 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.
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.
Patients with abnormal laboratory inspection indicators
Time frame: 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.
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 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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
71 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Non-small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 71 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dingzhi Huang, Doctor (18622221232, dingzhi72@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: From randomization to the time of death from any cause, assessed up to 36 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.