Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer
KontRASt-02
A Randomized, Controlled, Open Label, Phase III Study Evaluating the Efficacy and Safety of JDQ443 Versus Docetaxel in Previously Treated Subjects With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer
2 other identifiers
interventional
95
25 countries
53
Brief Summary
This is a phase III randomized open label study designed to compare JDQ443 as monotherapy to docetaxel in participants with advanced non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation who have been previously treated with a platinum-based chemotherapy and immune checkpoint inhibitor therapy either in sequence or in combination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 nonsmall-cell-lung-cancer
Started Jun 2022
53 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
November 11, 2021
CompletedFirst Posted
Study publicly available on registry
November 24, 2021
CompletedStudy Start
First participant enrolled
June 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 23, 2026
April 21, 2026
April 1, 2026
4.2 years
November 11, 2021
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival (PFS)
PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. PFS is based on central assessment and using RECIST 1.1 criteria.
Approximately up to 24 months
Secondary Outcomes (14)
Overall Survival (OS)
Approximately up to 33 months
Overall Response Rate (ORR)
Approximately up to 33 months
Disease Control Rate (DCR)
Approximately up to 33 months
Time To Response (TTR)
Approximately up to 33 months
Duration of Response (DOR)
Approximately up to 33 months
- +9 more secondary outcomes
Study Arms (2)
JDQ443
EXPERIMENTALParticipants will be treated with JDQ443
Docetaxel
ACTIVE COMPARATORParticipant will be treated with docetaxel following local guidelines as per standard of care and product labels
Interventions
Eligibility Criteria
You may qualify if:
- Participant has histologically confirmed locally advanced/metastatic (stage IIIB/IIIC or IV)
- Participant has a KRAS G12C mutation present in tumor tissue or plasma prior to enrollment, as determined by a Novartis designated central laboratory or by accepted local tests.
- Participants has received one prior platinum-based chemotherapy regimen and one prior immune checkpoint inhibitor therapy for locally advanced or metastatic disease
- Participant has at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1 at the screening visit.
You may not qualify if:
- Participants who have previously received docetaxel (except if received in neoadjuvant or adjuvant setting with no progression within 12 months after the of end of treatment), or any other KRAS G12C inhibitor.
- Participant has EGFR-sensitizing mutation and/or ALK rearrangement by local laboratory testing. Participants with other druggable alterations will be excluded if required by local guidelines.
- Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Participant has an history of interstitial lung disease or pneumonitis grade \> 1.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
Valley Medical Center Research
Renton, Washington, 98055, United States
Novartis Investigative Site
CABA, Buenos Aires, C1414DRK, Argentina
Novartis Investigative Site
Pilar, Buenos Aires, B1629AHJ, Argentina
Novartis Investigative Site
Auchenflower, Queensland, 4066, Australia
Novartis Investigative Site
South Brisbane, Queensland, 4101, Australia
Novartis Investigative Site
Montreal, Quebec, H4A 3J1, Canada
Novartis Investigative Site
Sherbrooke, Quebec, J1H 5N4, Canada
Novartis Investigative Site
Fuzhou, Fujian, 350014, China
Novartis Investigative Site
Guangzhou, Guangdong, 510030, China
Novartis Investigative Site
Guangzhou, Guangdong, 510080, China
Novartis Investigative Site
Harbin, Heilongjiang, 150081, China
Novartis Investigative Site
Changsha, Hunan, 410013, China
Novartis Investigative Site
Shengyang, Liaoning, 110042, China
Novartis Investigative Site
Jinan, Shandong, 250117, China
Novartis Investigative Site
Hangzhou, Zhejiang, 310003, China
Novartis Investigative Site
Beijing, 100730, China
Novartis Investigative Site
Chongqing, 400042, China
Novartis Investigative Site
Turku, FI-20521, Finland
Novartis Investigative Site
Athens, GR, 115 27, Greece
Novartis Investigative Site
Athens, 11526, Greece
Novartis Investigative Site
Heraklion Crete., 715 00, Greece
Novartis Investigative Site
Hong Kong, 999077, Hong Kong
Novartis Investigative Site
Kowloon, 999077, Hong Kong
Novartis Investigative Site
Budapest, 1121, Hungary
Novartis Investigative Site
Reykjavik, 101, Iceland
Novartis Investigative Site
Jaipur, Rajasthan, 302019, India
Novartis Investigative Site
Delhi, 110085, India
Novartis Investigative Site
Lucca, LU, 55100, Italy
Novartis Investigative Site
Aviano, PN, 33081, Italy
Novartis Investigative Site
Roma, RM, 00128, Italy
Novartis Investigative Site
Amman, 11941, Jordan
Novartis Investigative Site
Ed Daoura, 90375, Lebanon
Novartis Investigative Site
Kuching, Sarawak, 93586, Malaysia
Novartis Investigative Site
Kuala Lumpur, 59100, Malaysia
Novartis Investigative Site
Mexico City, 06760, Mexico
Novartis Investigative Site
Matosinhos Municipality, 4454-513, Portugal
Novartis Investigative Site
Porto, 4100-180, Portugal
Novartis Investigative Site
Cluj-Napoca, Cluj, 400015, Romania
Novartis Investigative Site
Ljubljana, 1000, Slovenia
Novartis Investigative Site
Seongnam-si, Gyeonggi-do, 13620, South Korea
Novartis Investigative Site
Pamplona, Navarre, 31008, Spain
Novartis Investigative Site
Oviedo, Principality of Asturias, 33011, Spain
Novartis Investigative Site
Córdoba, 14004, Spain
Novartis Investigative Site
Madrid, 28009, Spain
Novartis Investigative Site
Tainan, 704302, Taiwan
Novartis Investigative Site
Bangkok, 10330, Thailand
Novartis Investigative Site
Adana, Adana, 01140, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Bilkent-Cankaya, 06800, Turkey (Türkiye)
Novartis Investigative Site
Istanbul, Fatih, 34093, Turkey (Türkiye)
Novartis Investigative Site
Istanbul, Pendik, 34899, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Yenimahalle, 06500, Turkey (Türkiye)
Novartis Investigative Site
Ankara, 06680, Turkey (Türkiye)
Novartis Investigative Site
Hanoi, 300000, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2021
First Posted
November 24, 2021
Study Start
June 15, 2022
Primary Completion (Estimated)
August 25, 2026
Study Completion (Estimated)
September 23, 2026
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.