Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer
NCT ID: NCT05132075
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
95 participants
INTERVENTIONAL
2022-06-15
2026-03-30
Brief Summary
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Detailed Description
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* Randomized part will evaluate the efficacy and safety of JDQ443 as monotherapy in comparison with docetaxel. Participants randomized to docetaxel arm will have the opportunity to cross-over to JDQ443 at disease progression per RECIST 1.1 confirmed by BIRC.
* Extension part will be open after final progression-free survival (PFS) analysis (if the primary endpoint has met statistical significance) to allow participants randomized to docetaxel treatment to crossover to receive JDQ443 treatment regardless of progression on docetaxel.
The study population will include adult participants with locally advanced or metastatic (stage IIIB/IIIC or IV) KRAS G12C mutant non-small cell lung cancer (by tissue or plasma as determined by a Novartis-designated central laboratory or accepted local tests) who have received prior platinum-based chemotherapy and prior immune checkpoint inhibitor therapy administered either in sequence or as combination therapy.
Approximately 360 participants will be randomized to JDQ443 or docetaxel in a 1:1 ratio stratified by prior line of therapy and ECOG performance status.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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JDQ443
Participants will be treated with JDQ443
JDQ443
JDQ443 tablets, orally administered
Docetaxel
Participant will be treated with docetaxel following local guidelines as per standard of care and product labels
docetaxel
docetaxel concentrated solution for infusion, intravenously administered
Interventions
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JDQ443
JDQ443 tablets, orally administered
docetaxel
docetaxel concentrated solution for infusion, intravenously administered
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Valley Medical Center Research
Renton, Washington, United States
Novartis Investigative Site
CABA, Buenos Aires, Argentina
Novartis Investigative Site
Pilar, Buenos Aires, Argentina
Novartis Investigative Site
Auchenflower, Queensland, Australia
Novartis Investigative Site
South Brisbane, Queensland, Australia
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Sherbrooke, Quebec, Canada
Novartis Investigative Site
Beijing, Beijing Municipality, China
Novartis Investigative Site
Fuzhou, Fujian, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Harbin, Heilongjiang, China
Novartis Investigative Site
Changsha, Hunan, China
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Shengyang, Liaoning, China
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Jinan, Shandong, China
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Hangzhou, Zhejiang, China
Novartis Investigative Site
Chongqing, , China
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Turku, , Finland
Novartis Investigative Site
Athens, GR, Greece
Novartis Investigative Site
Athens, , Greece
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Heraklion Crete., , Greece
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Hong Kong, , Hong Kong
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Kowloon, , Hong Kong
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Budapest, , Hungary
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Reykjavik, , Iceland
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Jaipur, Rajasthan, India
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Delhi, , India
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Lucca, LU, Italy
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Aviano, PN, Italy
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Roma, RM, Italy
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Amman, , Jordan
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Ed Daoura, , Lebanon
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Kuching, Sarawak, Malaysia
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Kuala Lumpur, , Malaysia
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Mexico City, , Mexico
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Matosinhos Municipality, , Portugal
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Porto, , Portugal
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Cluj-Napoca, Cluj, Romania
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Ljubljana, , Slovenia
Novartis Investigative Site
Seongnam-si, Gyeonggi-do, South Korea
Novartis Investigative Site
Pamplona, Navarre, Spain
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Oviedo, Principality of Asturias, Spain
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Córdoba, , Spain
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Madrid, , Spain
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Tainan, , Taiwan
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Bangkok, , Thailand
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Adana, Adana, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Bilkent-Cankaya, Turkey (Türkiye)
Novartis Investigative Site
Istanbul, Fatih, Turkey (Türkiye)
Novartis Investigative Site
Istanbul, Pendik, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Yenimahalle, Turkey (Türkiye)
Novartis Investigative Site
Ankara, , Turkey (Türkiye)
Novartis Investigative Site
Hanoi, , Vietnam
Countries
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Other Identifiers
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2023-510082-10-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CJDQ443B12301
Identifier Type: -
Identifier Source: org_study_id