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

April 25, 2024 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

522

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230002
        • Not yet recruiting
        • Anhui Province Hospital
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100021
        • Not yet recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
      • Beijing, Beijing, China, 100142
        • Not yet recruiting
        • Beijing Cancer Hospital
        • Contact:
      • Beijing, Beijing, China, 100191
        • Not yet recruiting
        • Peking University Third Hospital
        • Contact:
      • Beijing, Beijing, China, 100053
        • Not yet recruiting
        • Xuanwu Hospital Capital Medical University
        • Contact:
      • Beijing, Beijing, China, 101149
        • Not yet recruiting
        • Beijing Chest Hospital,Capital Medical University
        • Contact:
      • Beijing, Beijing, China, 222002
        • Not yet recruiting
        • The Fifth Medical Center of Chinese PLA General Hospital
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 404100
        • Not yet recruiting
        • Chongqing University Three Gorges Hospital
        • Contact:
      • Chongqing, Chongqing, China, 400010
        • Not yet recruiting
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contact:
      • Chongqing, Chongqing, China, 400032
        • Not yet recruiting
        • Chongqing Cancer Hospital
        • Contact:
      • Chongqing, Chongqing, China, 400038
        • Not yet recruiting
        • The Southwest Hospital of Amu
        • Contact:
      • Chongqing, Chongqing, China, 400042
        • Not yet recruiting
        • Army Medical Center
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Not yet recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
      • Fuzhou, Fujian, China, 350001
        • Not yet recruiting
        • Fujian Medical University Union Hospital
        • Contact:
      • Fuzhou, Fujian, China, 350500
        • Not yet recruiting
        • Fujian Cancer Hospital
        • Contact:
      • Xiamen, Fujian, China, 361003
        • Not yet recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Not yet recruiting
        • Lanzhou University Second Hospital
        • Contact:
      • Lanzhou, Gansu, China, 730050
        • Not yet recruiting
        • Gansu Provincial Cancer Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510399
        • Not yet recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:
      • Guangzhou, Guangdong, China, 528405
        • Not yet recruiting
        • The First Affiliated Hospital of Guangdong Pharmaceutical University
        • Contact:
      • Zhanjiang, Guangdong, China, 524001
        • Not yet recruiting
        • The Affiliated Hospital of Guangdong Medical University
        • Contact:
    • Guangxi
      • Guilin, Guangxi, China, 541199
        • Not yet recruiting
        • The Second Affiliated Hospital of Guilin Medical College
        • Contact:
      • Nanning, Guangxi, China, 530020
        • Not yet recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
      • Yulin, Guangxi, China, 537000
        • Not yet recruiting
        • Yulin First People's Hospital
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China, 550002
        • Not yet recruiting
        • Guizhou Provincial People's Hospital
        • Contact:
      • Zunyi, Guizhou, China, 563000
        • Not yet recruiting
        • The Second Affiliated Hospital of Zunyi Medical University
        • Contact:
    • Hainan
      • Haikou, Hainan, China, 570311
        • Not yet recruiting
        • Hainan Provincial People's Hospital
        • Contact:
    • Hebei
      • Baoding, Hebei, China, 050031
        • Not yet recruiting
        • Affiliated Hospital of Hebei University
        • Contact:
      • Chengde, Hebei, China, 067028
        • Not yet recruiting
        • The Affiliated Hospital of Chengde Medical College
        • Contact:
      • Shijiazhuang, Hebei, China, 050011
        • Not yet recruiting
        • The Fourth Hospital of Hebei Medical University
        • Contact:
      • Tangshan, Hebei, China, 063001
        • Not yet recruiting
        • Tangshan People's Hospital
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Not yet recruiting
        • The Second Affiliated Hospital of Harbin Medical University
        • Contact:
      • Harbin, Heilongjiang, China, 150000
        • Not yet recruiting
        • Affiliated Cancer Hospital of Harbin Medical University
        • Contact:
      • Jiamusi, Heilongjiang, China, 154000
        • Not yet recruiting
        • Jiamusi Tuberculosis Hospital(Jiamusi Cancer Hospital)
        • Contact:
    • Henan
      • Anyang, Henan, China, 455001
        • Not yet recruiting
        • Anyang Tumor Hospital
        • Contact:
      • Luoyang, Henan, China, 471003
        • Not yet recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
      • Nanyang, Henan, China, 473000
        • Not yet recruiting
        • Nanyang Second General Hospital
        • Contact:
      • Nanyang, Henan, China, 473007
        • Not yet recruiting
        • The First Affiliated Hospital of Nanyang Medical College
        • Contact:
      • Xinxiang, Henan, China, 453100
        • Not yet recruiting
        • The First Affiliated Hospital Of Xinxiang Medical Unerversity
        • Contact:
      • Xuchang, Henan, China, 461000
        • Not yet recruiting
        • Xuchang Central Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450008
        • Not yet recruiting
        • Henan Cancer Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450052
        • Not yet recruiting
        • The First Affiliated Hospital Zhejiang University School Of Medicine
        • Contact:
      • Zhengzhou, Henan, China, 463599
        • Not yet recruiting
        • Henan Provincial People's Hospita
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Not yet recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
      • Wuhan, Hubei, China, 430030
        • Not yet recruiting
        • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410011
        • Not yet recruiting
        • The Second Xiangya Hospital Of Central South University
        • Contact:
      • Changsha, Hunan, China, 410031
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
      • Changsha, Hunan, China, 410013
        • Not yet recruiting
        • The third xiangya hospital of Central South University
        • Contact:
      • Changsha, Hunan, China, 410119
        • Not yet recruiting
        • Xiangya Hospital Central South University
        • Contact:
    • Jiangsu
      • Changzhou, Jiangsu, China, 213004
        • Not yet recruiting
        • The First People's Hospital of Changzhou
        • Contact:
          • Mei Ji, Doctor
          • Phone Number: 0519-68871123
          • Email: jimei@163.com
      • Nanjing, Jiangsu, China, 210009
        • Not yet recruiting
        • Jiangsu Cancer Hospital
        • Contact:
      • Nanjing, Jiangsu, China, 210007
        • Not yet recruiting
        • General Hospital of Eastern Theater Command
        • Contact:
      • Nantong, Jiangsu, China, 226006
        • Not yet recruiting
        • Nantong Tumor Hospital
        • Contact:
      • Wuxi, Jiangsu, China, 214023
        • Not yet recruiting
        • Wuxi People's Hospital
        • Contact:
      • Wuxi, Jiangsu, China, 214400
        • Not yet recruiting
        • Jiangyin People'S Hospital
        • Contact:
      • Xuzhou, Jiangsu, China, 221009
        • Not yet recruiting
        • Xuzhou Central Hospital
        • Contact:
      • Xuzhou, Jiangsu, China, 221004
        • Not yet recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Not yet recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
      • Nanchang, Jiangxi, China, 330006
        • Not yet recruiting
        • Jiangxi Provincial People's Hospital
        • Contact:
      • Nanchang, Jiangxi, China, 330029
        • Not yet recruiting
        • Jiangxi Cancer Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130000
        • Not yet recruiting
        • Jilin Cancer Hospital
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110002
        • Not yet recruiting
        • The First Affiliated Hospital of China Medical University
        • Contact:
      • Shenyang, Liaoning, China, 110022
        • Not yet recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250117
        • Not yet recruiting
        • Shandong Cancer Hospitai
        • Contact:
      • Jining, Shandong, China, 272011
        • Not yet recruiting
        • Jining First People's Hospital
        • Contact:
      • Qingdao, Shandong, China, 266011
        • Not yet recruiting
        • Qingdao Municipal Hospital
        • Contact:
      • Tai'an, Shandong, China, 271000
        • Not yet recruiting
        • The Second Affiliated Hospital of Shandong First Medical University
        • Contact:
      • Weifang, Shandong, China, 261000
        • Not yet recruiting
        • Weifang People's Hospital
        • Contact:
      • Weihai, Shandong, China, 264299
        • Not yet recruiting
        • Weihai Municipal Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:
      • Shanghai, Shanghai, China, 200025
        • Not yet recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
    • Shanxi
      • Changzhi, Shanxi, China, 046000
        • Not yet recruiting
        • Changzhi People's Hospital
        • Contact:
        • Contact:
      • Taiyuan, Shanxi, China, 030013
        • Not yet recruiting
        • Shanxi Provincial Cancer Hospital
        • Contact:
      • Xi'an, Shanxi, China, 710061
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
      • Xian, Shanxi, China, 710032
        • Not yet recruiting
        • The Second Affiliated Hospital of Air Force Medical University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Not yet recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
      • Luzhou, Sichuan, China, 646000
        • Not yet recruiting
        • The Affiliated Hospital Of Southwest Medical Unerversity
        • Contact:
      • Mianyang, Sichuan, China, 621099
        • Not yet recruiting
        • Mianyang Central Hospital
        • Contact:
      • Neijiang, Sichuan, China, 641000
        • Not yet recruiting
        • The Second People's Hospital of Neijiang
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300181
        • Not yet recruiting
        • Tianjin medical University cancer
        • Contact:
    • Xinjiang
      • Urumqi, Xinjiang, China, 830054
        • Not yet recruiting
        • The Affiliated Tumor Hospital of Xinjiang Medical University
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650118
        • Not yet recruiting
        • Yunnan Cancer Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Not yet recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
      • Hangzhou, Zhejiang, China, 310009
        • Not yet recruiting
        • The First Affiliated Hospital Zhejiang University School Of Medicine
        • Contact:
      • Wenzhou, Zhejiang, China, 325000
        • Not yet recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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:

    1. New York Heart Association (NYHA) Heart Function Grade II and above congestive heart failure;
    2. Severe cardiac arrhythmias requiring medical treatment;
    3. Acute myocardial infarction, severe or unstable angina pectoris, coronary or peripheral artery bypass surgery within 6 months prior to enrollment;
    4. Left ventricular ejection fraction (LVEF) <50%;
    5. QT interval (QTcF) at prolonged;
    6. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: D-1553 Tablet
D-1553 Tablet，21 days as a treatment cycle.
Drug: D-1553 Tablet
D-1553 is a KRAS inhibitor.
Active Comparator: Docetaxel Injection
Docetaxel Injection，21 days as a treatment cycle.
Drug: Docetaxel injection
Docetaxel, is an anti-tumor drug, significantly reduces the number of free tubules by promoting tubule polymerization into stable microtubules and inhibiting their depolymerization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Baseline up to 3 years
From randomization to the time of death from any cause.
Baseline up to 3 years
Objective mitigation rate (ORR)
Time Frame: Baseline up to 3 years

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).
Baseline up to 3 years
Duration of Response (DOR)
Time Frame: Baseline up to 3 years
From the time of tumor first evaluated as complete or partial response to the time of first disease progression or death from various causes.
Baseline up to 3 years
Disease control rate (DCR)
Time Frame: Baseline up to 3 years

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).
Baseline up to 3 years
Time to response (TTR)
Time Frame: Baseline up to 3 years
Time from patient randomization (first treatment) to first response per RECIST 1.1 criteria
Baseline up to 3 years
Patient-reported outcome (PRO)
Time Frame: Baseline up to 3 years
Reports of their health status directly from patients
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
The occurrence of laboratory test indicators exceed the normal range
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
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs)
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.
Time to maximum plasma concentration after dosing
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.
Time required for plasma concentrations to drop by half
Pre-dose and 2 hours after D1553 administration on Day 1 of cycle 1 and cycle 3. Each cycle is 21 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 3, 2024

First Submitted That Met QC Criteria

March 3, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1553-III-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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