Actively Recruiting
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
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2024-04-26
522
Participants Needed
86
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent and ability to follow study procedures
- Age 18 years or older, male or female, with ECOG performance status 0-1 and expected survival of at least 3 months
- Pathologically confirmed locally advanced, unresectable or metastatic non-small cell lung cancer (stage IIIb/IIIc/IV)
- Provide sufficient tumor tissue sample within 2 years prior to screening for KRAS G12C mutation confirmation
- Disease progression or intolerance after prior first-line anti-PD-1/PD-L1 and platinum-containing chemotherapy
- At least one measurable target lesion per RECIST 1.1
- Adequate major organ function
- Female participants of childbearing potential must use contraception during and for 6 months after the study, with a negative pregnancy test within 7 days before enrollment; males must agree to use contraception during and for 6 months after the study
You will not qualify if you...
- Prior treatment with KRAS G12C inhibitors or docetaxel
- NSCLC with other driver gene mutations
- Symptomatic or worsening brain metastases or carcinomatous meningitis; clinically stable brain metastases allowed
- History of epilepsy or presence of superior vena cava syndrome
- Significant cardiovascular conditions including NYHA class II or higher heart failure, severe arrhythmias requiring treatment, recent myocardial infarction or unstable angina within 6 months, LVEF below 50%, prolonged QT interval, or uncontrolled hypertension
- Stroke or severe cerebrovascular disease within 6 months
- Recent history (within 3 months) of deep vein thrombosis or serious thromboembolism
- History or active interstitial lung disease, radiation pneumonitis, immune-related pneumonia, active tuberculosis, pneumoconiosis, or severe impaired lung function
- Severe bone damage from tumor metastasis currently or post-randomization
- Active or uncontrolled serious infection or fever above 38.5C
- Uncontrolled third space effusions requiring treatment
- Known impaired gastrointestinal function affecting drug absorption or metabolism
- History of major digestive tract surgery impacting drug absorption or inability to swallow study drugs
- Unresolved toxicities from prior cancer therapy above grade 1 (except alopecia, pigmentation, minor labs) or peripheral nerve toxicity above grade 2
- HIV positive, liver cirrhosis, or active viral hepatitis
- Active syphilis
- Renal failure requiring dialysis
- Poorly controlled diabetes (fasting blood glucose >10 mmol/L)
- Previous organ transplantation or planned transplantation
- Weight under 40 kg or BMI under 18.5 kg/m2, or more than 5% weight loss in last 3 months
- Major surgery or significant trauma within 4 weeks prior to first dose
- Palliative radiotherapy within 2 weeks prior to first dose
- Pregnant or breastfeeding
- Other primary malignancies
- Serious mental illness, substance abuse, or serious alcohol abuse
- Known allergy to investigational drugs or any ingredient
- Any other significant condition posing risk or interfering with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 86 locations
1
Anhui Province Hospital
Hefei, Anhui, China, 230002
Not Yet Recruiting
2
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Not Yet Recruiting
3
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100053
Not Yet Recruiting
4
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Not Yet Recruiting
5
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Not Yet Recruiting
6
Beijing Chest Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 101149
Not Yet Recruiting
7
The Fifth medical center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 222002
Not Yet Recruiting
8
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010
Not Yet Recruiting
9
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China, 400032
Not Yet Recruiting
10
The Southwest hospital of AMU
Chongqing, Chongqing Municipality, China, 400038
Not Yet Recruiting
11
Army Medical Center
Chongqing, Chongqing Municipality, China, 400042
Not Yet Recruiting
12
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China, 404100
Not Yet Recruiting
13
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Not Yet Recruiting
14
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, Fujian, China, 350005
Not Yet Recruiting
15
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350500
Not Yet Recruiting
16
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Not Yet Recruiting
17
Lanzhou University Second Hospital
Lanzhou, Gansu, China, 730030
Not Yet Recruiting
18
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China, 730050
Not Yet Recruiting
19
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510399
Not Yet Recruiting
20
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China, 528405
Not Yet Recruiting
21
The Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China, 524001
Not Yet Recruiting
22
The Second Affiliated Hospital of Guilin Medical College
Guilin, Guangxi, China, 541199
Not Yet Recruiting
23
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530020
Not Yet Recruiting
24
Yulin First People's Hospital
Yulin, Guangxi, China, 537000
Not Yet Recruiting
25
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China, 550002
Not Yet Recruiting
26
The Second Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China, 563000
Not Yet Recruiting
27
Hainan Provincial People's Hospital
Haikou, Hainan, China, 570311
Not Yet Recruiting
28
Affiliated Hospital of Hebei University
Baoding, Hebei, China, 050031
Not Yet Recruiting
29
The Affiliated Hospital of Chengde Medical College
Chengde, Hebei, China, 067028
Not Yet Recruiting
30
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050011
Not Yet Recruiting
31
Tangshan People's Hospital
Tangshan, Hebei, China, 063001
Not Yet Recruiting
32
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150000
Not Yet Recruiting
33
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150000
Not Yet Recruiting
34
Jiamusi Tuberculosis Hospital(Jiamusi Cancer Hospital)
Jiamusi, Heilongjiang, China, 154000
Not Yet Recruiting
35
Anyang Tumor Hospital
Anyang, Henan, China, 455001
Not Yet Recruiting
36
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China, 471003
Not Yet Recruiting
37
Nanyang second general hospital
Nanyang, Henan, China, 473000
Not Yet Recruiting
38
The First affiliated Hospital of Nanyang Medical College
Nanyang, Henan, China, 473007
Not Yet Recruiting
39
The First Affiliated Hospital Of Xinxiang Medical Unerversity
Xinxiang, Henan, China, 453100
Not Yet Recruiting
40
Xuchang Central Hospital
Xuchang, Henan, China, 461000
Not Yet Recruiting
41
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Not Yet Recruiting
42
The First Affiliated Hospital Zhejiang University School of Medicine
Zhengzhou, Henan, China, 450052
Not Yet Recruiting
43
Henan Provincial People's Hospita
Zhengzhou, Henan, China, 463599
Not Yet Recruiting
44
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China, 430030
Not Yet Recruiting
45
Zhongnan hospital of Wuhan University
Wuhan, Hubei, China, 430071
Not Yet Recruiting
46
The Second Xiangya Hospital Of Central South University
Changsha, Hunan, China, 410011
Not Yet Recruiting
47
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
Not Yet Recruiting
48
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Not Yet Recruiting
49
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Not Yet Recruiting
50
Xiangya Hospital Central South University
Changsha, Hunan, China, 410119
Not Yet Recruiting
51
The first people's hospital of Changzhou
Changzhou, Jiangsu, China, 213004
Not Yet Recruiting
52
General Hospital of eastern theater command
Nanjing, Jiangsu, China, 210007
Not Yet Recruiting
53
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China, 210009
Not Yet Recruiting
54
Nantong Tumor Hospital
Nantong, Jiangsu, China, 226006
Not Yet Recruiting
55
Wuxi People's Hospital
Wuxi, Jiangsu, China, 214023
Not Yet Recruiting
56
Jiangyin People's Hospital
Wuxi, Jiangsu, China, 214400
Not Yet Recruiting
57
The Affiliated Hospital Of XuZhou Medical University
Xuzhou, Jiangsu, China, 221004
Not Yet Recruiting
58
Xuzhou Central Hospital
Xuzhou, Jiangsu, China, 221009
Not Yet Recruiting
59
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
60
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
61
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China, 330029
Not Yet Recruiting
62
Jilin Cancer Hospital
Changchun, Jilin, China, 130000
Not Yet Recruiting
63
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 110002
Not Yet Recruiting
64
Shengjing hospital of China medical university
Shenyang, Liaoning, China, 110022
Not Yet Recruiting
65
Shandong Cancer Hospitai
Jinan, Shandong, China, 250117
Not Yet Recruiting
66
Jining First People's Hospital
Jining, Shandong, China, 272011
Not Yet Recruiting
67
Qingdao Municipal Hospital
Qingdao, Shandong, China, 266011
Not Yet Recruiting
68
The Second Affiliated Hospital of Shandong First Medical University
Tai’an, Shandong, China, 271000
Not Yet Recruiting
69
Weifang people's Hospital
Weifang, Shandong, China, 261000
Not Yet Recruiting
70
Weihai Municipal Hospital
Weihai, Shandong, China, 264299
Not Yet Recruiting
71
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
Shanghai, Shanghai Municipality, China, 200025
Not Yet Recruiting
72
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
73
Changzhi People's Hospital
Changzhi, Shanxi, China, 046000
Not Yet Recruiting
74
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China, 030013
Not Yet Recruiting
75
The Second Affiliated Hospital of Air Force Medical University
Xian, Shanxi, China, 710032
Not Yet Recruiting
76
The First Affiliated Hospital of Xi'An JiaoTong University
Xi’an, Shanxi, China, 710061
Not Yet Recruiting
77
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Not Yet Recruiting
78
The Affiliated Hospital Of Southwest Medical Unerversity
Luzhou, Sichuan, China, 646000
Not Yet Recruiting
79
Mianyang Central Hospital
Mianyang, Sichuan, China, 621099
Not Yet Recruiting
80
The second people's hospital of neijiang
Neijiang, Sichuan, China, 641000
Not Yet Recruiting
81
Tianjin medical University cancer
Tianjin, Tianjin Municipality, China, 300181
Not Yet Recruiting
82
The Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China, 830054
Not Yet Recruiting
83
Yunnan Cancer Hospital
Kunming, Yunnan, China, 650118
Not Yet Recruiting
84
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Not Yet Recruiting
85
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Not Yet Recruiting
86
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Not Yet Recruiting
Research Team
S
Shun Lu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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