Non Small Cell Lung CancerPhase 3NCT06300177

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 Phase 3 study testing D-1553 Tablet and Docetaxel injection in people with Non Small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 86 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non Small Cell Lung Cancer
What is being tested?: D-1553 Tablet and Docetaxel injection
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 522 participants
Where: 86 sitesChina
Study dates: 28 Mar 2024to Dec 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 33Show fewer

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;
Active or uncontrolled serious infection (≥grade 2 infection of common toxicity criteria for adverse events (CTC AE)) or fever of unknown origin > 38.5°C;
The third space effusion (including pleural effusion, abdominal effusion or pericardial effusion), poor clinical control or the need for local symptomatic treatment such as puncture and drainage;
Known impaired gastrointestinal (GI) function or known GI diseases that may significantly affect the absorption or metabolism of oral drugs.
Previous history of major surgery in the digestive tract (esophagus, gastrointestinal tract) that may alter the absorption or inability to swallow drugs in the study treatment;
Toxicity of previous antitumor therapy, except alopecia, pigmentation, clinically insignificant laboratory abnormalities) has not recovered to grade 1, and peripheral nerve toxicity has not recovered to grade 2 ( CTCAE v5.0);
Human immunodeficiency virus (HIV) antibody positive, liver cirrhosis or active viral hepatitis;
Active syphilis;
Patients with renal failure requiring hemodialysis or peritoneal dialysis;
Poor diabetes control [fasting blood glucose (FBG)> 10 mmol/L];
Previous history of organ transplantation or readiness to undergo organ transplantation;
Weight of <40 kg and BMI of <18.5 kg/m2, or weight loss of> 5% within 3 months before enrollment;
Major surgical treatment or significant traumatic injury within 4 weeks prior to the first dose of this study;
Receiving palliative radiotherapy with local lesions within 2 weeks before the first dose of this study;
Pregnant or lactating subjects;
With the combination of other primary malignancies
Serious mental or mental illness or history of substance abuse or serious alcohol abuse;
Known allergy to the investigational medicinal product or any ingredient in the formulation;
Any other significant clinical abnormality or disease that the investigator considers poses a risk to subject safety or interferes with the medication and evaluation of the clinical study.

Trial locations and contacts

86 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Shun Lu, Doctor contact

13601813062

shun_lu@hotmail.com

City, postcode or hospital

Sites recruiting now only

86 sites in 1 country

China86 sites, 86 recruiting

Anyang Tumor Hospital
Anyang, Henan, 455001
Yuanyuan Ji, Master, 13460856657, jiyuanyuan666@126.com
Not yet recruiting
Affiliated Hospital of Hebei University
Baoding, Hebei, 050031
Zizheng Song, Master, 13932268911, 13932268911@163.com
Not yet recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Yan Wang, Doctor, 13911793771, wangyanyifu@163.com
Not yet recruiting
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
Yi Zhang, Doctor, 13141370703, steven9130@sina.com
Not yet recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jian Fang, Bachelor, 13701224460, fangjian5555@yeah.net
Not yet recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Baoshan Cao, Doctor, 13641093518, caobaoshan0711@aliyun.com
Not yet recruiting
Beijing Chest Hospital,Capital Medical University
Beijing, Beijing Municipality, 101149
Tongmei Zhang, Doctor, 13683016715, tongmeibj@163.com
Not yet recruiting
The Fifth medical center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 222002
Junxun Ma, Doctor, 13699262799, majunxun74@126.com
Not yet recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130000
Ying Cheng, Doctor, 0431-80596003, jl.cheng@163.com
Not yet recruiting
The Second Xiangya Hospital Of Central South University
Changsha, Hunan, 410011
Fang Ma, Doctor, 13975806788, dr_fma@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
Bolin Chen, Doctor, 13787101898, chenbolin@hnca.org.cn
Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410031
Yongzhong Luo, Bachelor, 13607443876, luoyongzhong@hnca.org.cn
Not yet recruiting
Xiangya Hospital Central South University
Changsha, Hunan, 410119
Rongrong Zhou, Doctor, 13875898127, 664990095@qq.com
Not yet recruiting
Changzhi People's Hospital
Changzhi, Shanxi, 046000
Jun Zhao, Doctor, 13835578500, zhaojun380@163.com
Xianping Zhao, Bachelor, 13453503966, ZXP13453503966@126.com
Not yet recruiting
The first people's hospital of Changzhou
Changzhou, Jiangsu, 213004
Mei Ji, Doctor, 0519-68871123, jimei@163.com
Not yet recruiting
The Affiliated Hospital of Chengde Medical College
Chengde, Hebei, 067028
Qingshan Li, Bachelor, 15633142750, libing200865@126.com
Not yet recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Haitao Lan, Doctor, 18981838376, lanht@sina.com
Not yet recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Zhenzhou Yang, Doctor, 13883270881, yangzz1970@163.com
Not yet recruiting
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400032
Jianlin Long, Doctor, 17830326836, ga.longjianlin@163.com
Not yet recruiting
The Southwest hospital of AMU
Chongqing, Chongqing Municipality, 400038
Jianjun Li, Doctor, 13608319428, leejjun2007@163.com
Not yet recruiting
Army Medical Center
Chongqing, Chongqing Municipality, 400042
Mengxia Li, Doctor, 18580408265, 707849603@qq.com
Not yet recruiting
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 404100
Wei Wang, Master, 13635324483, 19574605@qq.com
Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Peifeng Hou, Doctor, 13799987620, 717217167@qq.com
Not yet recruiting
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, Fujian, 350005
Rixiong Wang, Doctor, 13960758357, 13960758357@163.com
Not yet recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350500
Jing Zhang, Master, 13809557405, cfcy813@sina.com
Not yet recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510399
Minghui Wang, Doctor, 13826276828, wmingh@mail.sysu.edu.cn
Not yet recruiting
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, 528405
Xintian Qin, Master, 13660558820, xintianqin@126.com
Not yet recruiting
The Second Affiliated Hospital of Guilin Medical College
Guilin, Guangxi, 541199
Bihui Li, Master, 18378316283, lbihui0202@163.com
Not yet recruiting
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002
Yu Zhang, Doctor, 18885146684, 248634489@qq.com
Not yet recruiting
Hainan Provincial People's Hospital
Haikou, Hainan, 570311
Yongxing Chen, Master, 13876825536, chen13876825536@163.com
Not yet recruiting
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Yina Wang, Doctor, 15957109041, sinead555@163.com
Not yet recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Pingli Wang, Doctor, 13516808409, W_pl77@163.com
Not yet recruiting
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
Baogang Liu, Doctor, 13804552752, liubaogang1962@sina.com
Not yet recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
Tao Xin, Doctor, 13633655999, xintao1234@263.net
Not yet recruiting
Anhui Province Hospital
Hefei, Anhui, 230002
Minghong Bao, Master, 15255187155, baomh2015@163.com
Not yet recruiting
Jiamusi Tuberculosis Hospital(Jiamusi Cancer Hospital)
Jiamusi, Heilongjiang, 154000
Hongmei Sun, Bachelor, 15344540000, SHM1357@163.com
Not yet recruiting
Shandong Cancer Hospitai
Jinan, Shandong, 250117
Hui Zhu, Doctor, 15805310022, drzhuhui@163.com
Not yet recruiting
Jining First People's Hospital
Jining, Shandong, 272011
Jie Li, Doctor, 13964921790, 13964921790@139.com
Not yet recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
Runxiang Yang, Master, 13888876721, 13888876721@163.com
Not yet recruiting
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030
Junnian Shi, Master, 13919778675, ldeyyzbgs@lzu.edu.cn
Not yet recruiting
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050
Xiting Liu, Bachelor, 13893296929, LXT-0421@163.com
Not yet recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003
Zhiye Zhang, Master, 13783100985, 13783100985@163.com
Not yet recruiting
The Affiliated Hospital Of Southwest Medical Unerversity
Luzhou, Sichuan, 646000
Peirong Ren, Master, 15883037066, 1097802221@qq.com
Not yet recruiting
Mianyang Central Hospital
Mianyang, Sichuan, 621099
Gang Feng, Doctor, 18141380968, 15520828768@163.com
Not yet recruiting
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006
Weirong Yao, Doctor, 13907002901, 13907002901@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
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Zhenntian Liu, Master, 15070083853, 345588506@qq.com
Not yet recruiting
General Hospital of eastern theater command
Nanjing, Jiangsu, 210007
Yong Song, Doctor, 13851761392, song_yong6310@126.com
Not yet recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Guohao Xia, Doctor, 13913976000, 13913976000@163.com
Not yet recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530020
Qing Bu, Doctor, 18277133566, 1332271797@qq.com
Not yet recruiting
Nantong Tumor Hospital
Nantong, Jiangsu, 226006
Junguo Liu, Bachelor, 13814603295, jsntzlyy@126.com
Not yet recruiting
Nanyang second general hospital
Nanyang, Henan, 473000
Qichuan Wang, Master, 13838709208, chuan12616@126.com
Not yet recruiting
The First affiliated Hospital of Nanyang Medical College
Nanyang, Henan, 473007
Peng Cheng, Master, 13782042723, oncologist@163.com
Not yet recruiting
The second people's hospital of neijiang
Neijiang, Sichuan, 641000
Yu Liu, Master, 13698308655, 13278258@qq.com
Not yet recruiting
Qingdao Municipal Hospital
Qingdao, Shandong, 266011
Mi Zhou, Master, 18561858073, mi_zhou1978@163.com
Not yet recruiting
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
Shanghai, Shanghai Municipality, 200025
Min Zhou, Doctor, 13681779624, doctor_zhou_99@163.com
Not yet recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Shun Lu, Doctor, 13601813062, shun_lu@hotmail.com
Recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110002
Yunpeng Liu, Doctor, 13898865122, cmu_trial@163.com
Not yet recruiting
Shengjing hospital of China medical university
Shenyang, Liaoning, 110022
Caigang Liu, Doctor, 18940254967, liucg@sj-hospital.org
Not yet recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Yudong Wang, Doctor, 15931166600, wyd_999@hebmu.edu.cn
Not yet recruiting
The Second Affiliated Hospital of Shandong First Medical University
Tai’an, Shandong, 271000
Haiyan Liu, Master, 18505387037, fylhy1998@163.com
Not yet recruiting
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013
Wei Guo, Master, 13834563396, guowei812@126.com
Not yet recruiting
Tangshan People's Hospital
Tangshan, Hebei, 063001
Junquan Yang, Doctor, 19131829092, 13313059092@163.com
Not yet recruiting
Tianjin medical University cancer
Tianjin, Tianjin Municipality, 300181
Xiubao Ren, Doctor, 18622221235, rwziyi@163.com
Not yet recruiting
The Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
Chunling Liu, Master, 13899931987, liudeyouxiang66@163.com
Not yet recruiting
Weifang people's Hospital
Weifang, Shandong, 261000
Wei Tan, Master, 13863659099, 13863659099@126.com
Not yet recruiting
Weihai Municipal Hospital
Weihai, Shandong, 264299
Fujun Yang, Doctor, 18660377195, 58500775@qq.com
Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Yanfan Chen, Doctor, 13600666600, chenyf2605@163.com
Not yet recruiting
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430030
Qian Chu, Doctor, 13212760751, qianchu@tjh.tjmu.edu.cn
Not yet recruiting
Zhongnan hospital of Wuhan University
Wuhan, Hubei, 430071
Junhong Zhang, Bachelor, 13638679004, Zjhzhongnan@163.com
Not yet recruiting
Wuxi People's Hospital
Wuxi, Jiangsu, 214023
Tao Bian, Doctor, 13358119859, biantaophd@126.com
Not yet recruiting
Jiangyin People's Hospital
Wuxi, Jiangsu, 214400
Dong Shen, Doctor, 15961663515, shendong@ntu.edu.cn
Not yet recruiting
The First Affiliated Hospital of Xi'An JiaoTong University
Xi’an, Shanxi, 710061
Xiaomin Dang, Doctor, 18991232795, dxming112@163.com
Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Feng Ye, Doctor, 13860458889, yefengdoctor@sina.com
Not yet recruiting
The Second Affiliated Hospital of Air Force Medical University
Xian, Shanxi, 710032
Haichuan Su, Doctor, 18629190366, cntdgcp@163.com
Not yet recruiting
The First Affiliated Hospital Of Xinxiang Medical Unerversity
Xinxiang, Henan, 453100
Weiwei Li, Master, 13837384916, 13837384916@163.com
Not yet recruiting
Xuchang Central Hospital
Xuchang, Henan, 461000
Pengyuan Wang, Master, 13837440693, wangpengyuan@126.com
Not yet recruiting
The Affiliated Hospital Of XuZhou Medical University
Xuzhou, Jiangsu, 221004
Zhengxiang Han, Doctor, 18052268612, cnhzxyq@163.com
Not yet recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009
Xiang Wang, Master, 18912007930, wangxiang7726@163.com
Not yet recruiting
Yulin First People's Hospital
Yulin, Guangxi, 537000
Haizhen Yi, Master, 15807851995, yhz228815@168.com
Not yet recruiting
The Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524001
Shujun Li, Master, 13726913133, lishujun072@163.com
Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Yanqiu Zhao, Master, 13938252350, 13938252350@163.com
Not yet recruiting
The First Affiliated Hospital Zhejiang University School of Medicine
Zhengzhou, Henan, 450052
Xingya Li, Doctor, 13838253946, lixingyavip@163.com
Not yet recruiting
Henan Provincial People's Hospita
Zhengzhou, Henan, 463599
Shundong Cang, Doctor, 13592675836, cangshundong@163.com
Not yet recruiting
The Second Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000
Yuju Bai, Master, 13984535566, byj6618@163.com
Not yet recruiting

Other trials in China

About this study

Official title: 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.

Conditions: Non Small Cell Lung Cancer
Being tested: D-1553 Tablet, Docetaxel injection
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.

D-1553 TabletDrug
D-1553 is a KRAS inhibitor.
Docetaxel injectionDrug
Docetaxel, is an anti-tumor drug, significantly reduces the number of free tubules by promoting tubule polymerization into stable microtubules and inhibiting their depolymerization.

Study groups in NCT06300177
Study group	Role	What they receive
D-1553 Tablet	Experimental	D-1553 Tablet，21 days as a treatment cycle. Receives: Drug: D-1553 Tablet
Docetaxel Injection	Active comparator	Docetaxel Injection，21 days as a treatment cycle. Receives: Drug: Docetaxel injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline up to 3 years

Secondary outcomes (10)

Overall survival (OS)
From randomization to the time of death from any cause.
Measured: Baseline up to 3 years
Objective mitigation rate (ORR)
According to RECIST 1.1 criteria, proportion of patients with confirmed tumor volume reduction to pre-specified values and maintained minimum requirements
, namely the proportion of patients with complete response (CR) and partial response (PR).
Measured: Baseline up to 3 years
Duration of Response (DOR)
From the time of tumor first evaluated as complete or partial response to the time of first disease progression or death from various causes.
Measured: Baseline up to 3 years
Disease control rate (DCR)
According to RECIST 1.1 criteria, proportion of patients with confirmed tumor volume reduction to pre-specified values and maintained minimum requirements
, namely the proportion of patients with CR, PR and stable disease (SD).
Measured: Baseline up to 3 years
Time to response (TTR)
Time from patient randomization (first treatment) to first response per RECIST 1.1 criteria
Measured: Baseline up to 3 years
Patient-reported outcome (PRO)
Reports of their health status directly from patients
Measured: Baseline up to 3 years
Abnormal laboratory test indicators
The occurrence of laboratory test indicators exceed the normal range
Measured: From the subject signed the informed consent form to 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 the subject signed the informed consent form to 30 days after the last dose
Time to Maximum Plasma Concentration (Tmax)
Time to maximum plasma concentration after dosing
Measured: Pre-dose and 2 hours after D1553 administration on Day 1 of cycle 1 and cycle 3. Each cycle is 21 days.
Half life (t1/2)
Time required for plasma concentrations to drop by half
Measured: Pre-dose and 2 hours after D1553 administration on Day 1 of cycle 1 and cycle 3. 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.

28 Mar 2024Dec 2027

First posted8 Mar 2024
Study start28 Mar 2024
Primary completionOct 2026 (estimated)
Study completionDec 2027 (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: 522 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06300177
Sponsor's protocol ID: D1553-III-01
Status last verified: Mar 2024
First submitted: 3 Mar 2024
Last updated: 26 Apr 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Shun Lu, Doctor

13601813062

shun_lu@hotmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 3
A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer
IO Resistant Squamous and Nonsquamous NSCLC
RecruitingPhase 3
MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)
Non-small Cell Lung Cancer
Not yet recruitingPhase 1
A Phase 1 Trial of KAN-001 With Pembrolizumab, With or Without Chemotherapy, in Participants With PD-L1-Positive Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
RecruitingObservational study
Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
Breast Carcinoma, Colorectal Carcinoma
RecruitingPhase 2
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
Advanced Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma

All Non Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT06300177
Acronym / sponsor ID: D1553-III-01
Conditions: Non Small Cell Lung Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 522 participants (estimated)
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
Study start: 28 Mar 2024 (actual)
Primary completion: Oct 2026 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 8 Mar 2024 (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.

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
D-1553 Tablet	Experimental	Drug: D-1553 TabletD-1553 Tablet，21 days as a treatment cycle.
Docetaxel Injection	Active comparator	Drug: Docetaxel injectionDocetaxel Injection，21 days as a treatment cycle.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (33 listed)

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:

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
D-1553 TabletD-1553 is a KRAS inhibitor.	Drug	D-1553 Tablet
Docetaxel injectionDocetaxel, is an anti-tumor drug, significantly reduces the number of free tubules by promoting tubule polymerization into stable microtubules and inhibiting their depolymerization.	Drug	Docetaxel Injection

Primary outcome

Progression-free survival (PFS)
Time frame: Baseline up to 3 years
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.

10 secondary outcomes

Overall survival (OS)
Time frame: Baseline up to 3 years
Objective mitigation rate (ORR)
Time frame: Baseline up to 3 years
Duration of Response (DOR)
Time frame: Baseline up to 3 years
Disease control rate (DCR)
Time frame: Baseline up to 3 years
Time to response (TTR)
Time frame: Baseline up to 3 years
Patient-reported outcome (PRO)
Time frame: Baseline up to 3 years
Abnormal laboratory test indicators
Time frame: From the subject signed the informed consent form to 30 days after the last dose
Adverse event rate
Time frame: From the subject signed the informed consent form to 30 days after the last dose
Time to Maximum Plasma Concentration (Tmax)
Time frame: Pre-dose and 2 hours after D1553 administration on Day 1 of cycle 1 and cycle 3. Each cycle is 21 days.
Half life (t1/2)
Time frame: Pre-dose and 2 hours after D1553 administration on Day 1 of cycle 1 and cycle 3. Each cycle is 21 days.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.

Related trials for Non Small Cell Lung Cancer

RecruitingPhase 3
A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer
IO Resistant Squamous and Nonsquamous NSCLC
RecruitingPhase 3
MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)
Non-small Cell Lung Cancer
Not yet recruitingPhase 1
A Phase 1 Trial of KAN-001 With Pembrolizumab, With or Without Chemotherapy, in Participants With PD-L1-Positive Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
RecruitingObservational study
Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
Breast Carcinoma, Colorectal Carcinoma
RecruitingPhase 2
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
Advanced Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma

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.

Shun Lu, Doctor contact

13601813062

shun_lu@hotmail.com

86 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing D-1553 Tablet and Docetaxel injection in people with Non Small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 86 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 8 inclusion and 33 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: looking for participants now, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shun Lu, Doctor (13601813062, shun_lu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: Baseline up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06300177.

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 26 Apr 2024.