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Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer
Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer

NCT05132075

Active Not RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Non-Small Cell Lung Cancer

Interventions: JDQ443, docetaxel

Countries: United States, Argentina, Australia, Canada, China, Finland, Greece, Hong Kong

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Other inclusion/exclusion criteria may apply
Locations (51)
  • Renton, Washington, United States
  • CABA, Buenos Aires, Argentina
  • Pilar, Buenos Aires, Argentina
  • Auchenflower, Queensland, Australia
  • South Brisbane, Queensland, Australia
  • Montreal, Quebec, Canada
  • Sherbrooke, Quebec, Canada
  • Fuzhou, Fujian, China
  • Guangzhou, Guangdong, China
  • Harbin, Heilongjiang, China
  • Changsha, Hunan, China
  • Shengyang, Liaoning, China
  • Jinan, Shandong, China
  • Hangzhou, Zhejiang, China
  • Beijing, China
  • Turku, Finland
  • Athens, GR, Greece
  • Athens, Greece
  • Heraklion Crete., Greece
  • Hong Kong, Hong Kong
  • Kowloon, Hong Kong
  • Budapest, Hungary
  • Reykjavik, Iceland
  • Jaipur, Rajasthan, India
  • Delhi, India
  • Lucca, LU, Italy
  • Aviano, PN, Italy
  • Roma, RM, Italy
  • Amman, Jordan
  • Ed Daoura, Lebanon
  • + 21 more on CT.gov