Clinical Trials List
2025-01-15 - 2032-12-01
Phase III
Recruiting5
ICD-10C34.90
Malignant neoplasm of unspecified part of unspecified bronchus or lung
ICD-10C34.91
Malignant neoplasm of unspecified part of right bronchus or lung
ICD-10C34.92
Malignant neoplasm of unspecified part of left bronchus or lung
ICD-10C7A.090
Malignant carcinoid tumor of the bronchus and lung
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9162.9
Malignant neoplasm of bronchus and lung, unspecified
A Randomized, Double-Blind, Phase 3 Trial of Adagrasib plus Pembrolizumab plus Chemotherapy vs. Placebo plus Pembrolizumab plus Chemotherapy in Participants with Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer with KRAS G12C Mutation (KRYSTAL-4)
-
Trial Applicant
BRISTOL-MYERS SQUIBB (TAIWAN) LTD.
-
Sponsor
Mirati Therapeutics Inc, a Bristol Myers Squibb Company
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Chin-Wei Kuo 無
- 蔡政軒 無
- Chien-Chung Lin 無
- Yu-Min Yeh 無
- Seu-Chun Yang 無
- 黃怡璇 無
- Shang-Yin Wu 無
- 黃怡菁 無
- Wu-Chou Su 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jih-Hsiang Lee 無
- 徐偉勛 無
- James Chih-Hsin Yang 無
- 蔡子修 無
- 吳尚俊 無
- 黃俊凱 無
- 廖斌志 無
- Chong-Jen Yu 無
- Chia-Chi Lin 無
- 陳冠宇 無
- 廖唯昱 無
- CHAO-CHI HO CHAO-CHI HO 無
- YEN-TING LIN 無
- 許嘉林 無
- 楊景堯 無
- 錢穎群 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
OS
Inclution Criteria
a) Participants must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF) in accordance with regulatory, local, and institutional guidelines. This ICF must be obtained before performing any protocol-related procedures that are not part of normal patient care.
b) Participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study requirements.
2) Type of Participant and Target Disease Characteristics
a) Histologically or cytologically confirmed diagnosis of non-squamous NSCLC.
b) Locally advanced or metastatic disease.
c) Measurable disease via computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria of at least 1 lesion.
d) Not a candidate for definitive therapy (eg, chemoradiation or complete surgical resection).
e) Evidence of KRAS G12C mutation via tumor tissuesample and/or ctDNA documented by Sponsor-approved laboratory testing (see Section 9.7.2).
f) Any PD-L1 expression (0 to 100%) as determined by VENTANA PD-L1 (SP263) assay, Agilent PD-L1 IHC 22C3 pharmDx, or Agilent PD-L1 IHC 28-8 pharmDx. If, despite best efforts, a quantifiable result is not possible, non-evaluable or non-quantifiable results may be acceptable upon Medical Monitor (or designee) approval for a maximum of 10% of total participants.
g) A representative tumor specimen (primary or metastatic and newly obtained or archival if < 6 months old) should be available to be submitted to the Sponsor during screening or within 15 business days post randomization as described in Section 9.7.3.
h) No prior systemic anti-cancer therapy given for advanced or metastatic disease, including chemotherapy, immunotherapy, targeted therapy (EGFR, ALK inhibitors, etc.), biologic therapy, or chemoradiation.
Note: Prior systemic neoadjuvant, adjuvant, or peri-operative systemic therapy is allowed if completed at least 6 months prior to the first dose. Prior definitive chemoradiation with or without maintenance anti-PD(L)-1 for locally advanced disease is permitted if the last administration of systemic therapy occurred at least 6 months prior to enrollment.
i) Participants with brain metastases are eligible for enrollment, including those with untreated brain metastases. Brain metastases must be asymptomatic and not in need of immediate local therapy. Any untreated brain metastases must be ≤ 20 mm in diameter.
Note: Participants treated with CNS local therapy for newly identified lesions found on brain imaging performed during screening for this study may be eligible to enroll if other sites of disease assessable by RECIST v1.1 are present and the following criteria are met: time since whole brain radiation therapy is ≥ 2114 days prior to randomization, time since stereotactic radiosurgery is ≥ 7 days prior to randomization, or time sincethe participant has healed following surgical resection, and there is ≥ 28 dayscomplete resolution of any acute RT- or surgical-related toxicities.
j) No evidence of leptomeningeal metastases (carcinomatous meningitis) or brainstem lesions.
k) ECOG PS of 0 or 1.
Exclusion Criteria
a) Have a documented additional targetable oncogenic driver mutation or alteration in genes such as EGFR, ALK, BRAF V600E, HER2, MET exon 14, ROS1, RET, or NTRK1/2/3 for which there is a standard of care treatment available (when. Note: testing is only required if results are available).mandated by local regulations.
b) History of previous cancer requiring therapy within the previous 2 years, except for squamous cell or basal-cell carcinoma of the skin or any in situ carcinoma that has been completely resected.
c) Major surgery within 4 weeks of randomization. Radiation therapy (except palliative to relieve bone pain or stereotactic radiosurgery as specified above) within 2 weeks of randomization. Palliative radiation (≤ 10 fractions) must have been completed at least 48 hours prior to randomization.
d) Uncontrolled or significant cardiovascular conditions within 6 months prior to enrollment, including, but not limited to, any of the following:
i) Myocardial infarction, unstable angina, coronary/peripheral artery bypass graft surgery, symptomatic peripheral vascular disease (ie, CTCAE v5.0 peripheral ischemia of any grade), class III or IV congestive heart failure (as defined by the New York Heart Association; refer to Appendix 8), cerebrovascular accident or transient ischemic attack, symptomatic bradycardia, pericarditis, or myocarditis;
ii) Ongoing clinically significant symptomatic cardiac dysrhythmias, history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes), prolonged QTc interval (> 480 milliseconds) or family or medical history of congenital long QT syndrome.
The Estimated Number of Participants
-
Taiwan
12 participants
-
Global
630 participants
