D-1553 Tablet Versus Docetaxel Injection for KRAS G12C Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer After Prior Standard Therapy Failure
A Randomized, Controlled, Double-blind, Double-simulated, Multicenter Phase III Clinical Study Evaluating D-1553 Tablet Versus Docetaxel Injection for KRAS G12C Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer After Prior Standard Therapy Failure.
1 other identifier
interventional
522
1 country
86
Brief Summary
The purpose of this project is to evaluate progression-free survival (PFS) of D-1553 Tablet versus Docetaxel Injection in subjects with prior standard therapy failure kirsten rat sarcoma viral oncogene (KRAS) G12C mutation positive locally advanced or metastatic non small cell lung cancer (NSCLC), progression-free survival (PFS) as assessed by the Independent Review Committee (IRC) based on RECIST 1.1 was used as the primary endpoint.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2024
Typical duration for phase_3
86 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
March 3, 2024
CompletedFirst Posted
Study publicly available on registry
March 8, 2024
CompletedStudy Start
First participant enrolled
March 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
April 26, 2024
March 1, 2024
2.5 years
March 3, 2024
April 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS)
Time from subject randomization (first treatment) to first disease progression or death from any cause, whichever occurred first, was assessed by an independent Review Committee (IRC) per Response evaluation criteria in solid tumors (RECIST) 1.1.
Baseline up to 3 years
Secondary Outcomes (10)
Overall survival (OS)
Baseline up to 3 years
Objective mitigation rate (ORR)
Baseline up to 3 years
Duration of Response (DOR)
Baseline up to 3 years
Disease control rate (DCR)
Baseline up to 3 years
Time to response (TTR)
Baseline up to 3 years
- +5 more secondary outcomes
Study Arms (2)
D-1553 Tablet
EXPERIMENTALD-1553 Tablet，21 days as a treatment cycle.
Docetaxel Injection
ACTIVE COMPARATORDocetaxel Injection，21 days as a treatment cycle.
Interventions
Docetaxel, is an anti-tumor drug, significantly reduces the number of free tubules by promoting tubule polymerization into stable microtubules and inhibiting their depolymerization.
Eligibility Criteria
You may qualify if:
- Voluntary participation in the study and sign of written informed consent after full informed consent, willing and able to comply with the study procedures and requirements specified in the protocol;
- Age greater than or equal to 18 years old; male and female; eastern cooperative oncology group performance status (ECOG) score 0-1; expected survival period greater than or equal to 3 months;
- Pathologically confirmed locally advanced, unresectable and / or metastatic non-small cell lung cancer (stage III b / III c / IV of american joint committee on cancer (AJCC) 8th);
- Subjects must provide adequate and qualified tumor tissue specimens (surgical resection samples or puncture / biopsy tissue samples within 2 years prior to screening) for confirmation of the KRAS G12C mutation in the central laboratory;
- Disease progression or toxicity after previous treatment with first-line anti-PD-1 / PD-L1 and platinum-containing chemotherapy is not tolerated.Subjects who have clear medical reasons and can not tolerate anti-PD-1 / PD-L1 therapy or platinum-containing chemotherapy;
- Having at least one target lesion according to RECIST 1.1;
- Good function of the major organs;
- Female subjects of childbearing age should agree that contraception must be used during the study and within 6 months after the end of the study; the serum pregnancy test is negative within 7 days before study enrollment and must be non-lactating subjects; male subjects should agree that contraception must be used during the study and within 6 months after the end of the study period.
You may not qualify if:
- Treatment with a KRAS G12C mutation inhibitor or docetaxel at any previous time;
- NSCLC with mutations of other driver genes;
- Symptomatic or progressive aggravation of central nervous system metastasis or cancerous meningitis. Subjects with a history of brain metastasis may be considered to be selected if they are clinically stable;
- Patients with a previous history of epilepsy；presence of superior vena cava syndrome;
- Cardiovascular system meets any condition:
- New York Heart Association (NYHA) Heart Function Grade II and above congestive heart failure;
- Severe cardiac arrhythmias requiring medical treatment;
- Acute myocardial infarction, severe or unstable angina pectoris, coronary or peripheral artery bypass surgery within 6 months prior to enrollment;
- Left ventricular ejection fraction (LVEF) \<50%;
- QT interval (QTcF) at prolonged;
- Hypertension that is not effectively controlled;
- Subjects with stroke or other severe cerebrovascular disease within 6 months before enrollment;
- History of deep vein thrombosis or any other serious thromboembolism within 3 months prior to enrollment;
- History of interstitial lung disease, radiation pneumonitis, and immune-associated pneumonia previously treated with steroids, Or active non-infectious pneumonia with interstitial lung disease, radiation pneumonia, and immune-related pneumonia during the screening period, Presence of active tuberculosis, pneumoconiosis or grade 2 other type of pneumonia, or pulmonary function tests confirming severely impaired pulmonary function;
- Severe bone damage due to tumor bone metastasis may occur at present or after randomization;
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (86)
Anhui Province Hospital
Hefei, Anhui, 230002, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Beijing Chest Hospital,Capital Medical University
Beijing, Beijing Municipality, 101149, China
The Fifth medical center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 222002, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400032, China
The Southwest hospital of AMU
Chongqing, Chongqing Municipality, 400038, China
Army Medical Center
Chongqing, Chongqing Municipality, 400042, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 404100, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, Fujian, 350005, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350500, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510399, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, 528405, China
The Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524001, China
The Second Affiliated Hospital of Guilin Medical College
Guilin, Guangxi, 541199, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530020, China
Yulin First People's Hospital
Yulin, Guangxi, 537000, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002, China
The Second Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000, China
Hainan Provincial People's Hospital
Haikou, Hainan, 570311, China
Affiliated Hospital of Hebei University
Baoding, Hebei, 050031, China
The Affiliated Hospital of Chengde Medical College
Chengde, Hebei, 067028, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011, China
Tangshan People's Hospital
Tangshan, Hebei, 063001, China
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000, China
Jiamusi Tuberculosis Hospital(Jiamusi Cancer Hospital)
Jiamusi, Heilongjiang, 154000, China
Anyang Tumor Hospital
Anyang, Henan, 455001, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003, China
Nanyang second general hospital
Nanyang, Henan, 473000, China
The First affiliated Hospital of Nanyang Medical College
Nanyang, Henan, 473007, China
The First Affiliated Hospital Of Xinxiang Medical Unerversity
Xinxiang, Henan, 453100, China
Xuchang Central Hospital
Xuchang, Henan, 461000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
The First Affiliated Hospital Zhejiang University School of Medicine
Zhengzhou, Henan, 450052, China
Henan Provincial People's Hospita
Zhengzhou, Henan, 463599, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430030, China
Zhongnan hospital of Wuhan University
Wuhan, Hubei, 430071, 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
Xiangya Hospital Central South University
Changsha, Hunan, 410119, China
The first people's hospital of Changzhou
Changzhou, Jiangsu, 213004, China
General Hospital of eastern theater command
Nanjing, Jiangsu, 210007, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009, China
Nantong Tumor Hospital
Nantong, Jiangsu, 226006, China
Wuxi People's Hospital
Wuxi, Jiangsu, 214023, China
Jiangyin People's Hospital
Wuxi, Jiangsu, 214400, China
The Affiliated Hospital Of XuZhou Medical University
Xuzhou, Jiangsu, 221004, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, 330006, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
Jilin Cancer Hospital
Changchun, Jilin, 130000, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110002, China
Shengjing hospital of China medical university
Shenyang, Liaoning, 110022, China
Shandong Cancer Hospitai
Jinan, Shandong, 250117, China
Jining First People's Hospital
Jining, Shandong, 272011, China
Qingdao Municipal Hospital
Qingdao, Shandong, 266011, China
The Second Affiliated Hospital of Shandong First Medical University
Tai’an, Shandong, 271000, China
Weifang people's Hospital
Weifang, Shandong, 261000, China
Weihai Municipal Hospital
Weihai, Shandong, 264299, China
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
Shanghai, Shanghai Municipality, 200025, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
Changzhi People's Hospital
Changzhi, Shanxi, 046000, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013, China
The Second Affiliated Hospital of Air Force Medical University
Xian, Shanxi, 710032, China
The First Affiliated Hospital of Xi'An JiaoTong University
Xi’an, Shanxi, 710061, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
The Affiliated Hospital Of Southwest Medical Unerversity
Luzhou, Sichuan, 646000, China
Mianyang Central Hospital
Mianyang, Sichuan, 621099, China
The second people's hospital of neijiang
Neijiang, Sichuan, 641000, China
Tianjin medical University cancer
Tianjin, Tianjin Municipality, 300181, China
The Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650118, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, 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
March 3, 2024
First Posted
March 8, 2024
Study Start
March 28, 2024
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
April 26, 2024
Record last verified: 2024-03