Active Not RecruitingPhase 3NCT05132075

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

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.

Checked against the public recordLast updated Aug 27, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 3
U.S. locations51
SponsorNovartis Pharmaceuticals
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Novartis Pharmaceuticals
Interventions being studied
Drug: JDQ443; Drug: docetaxel
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Valley Medical Center ResearchRenton, Washington
  • Novartis Investigative SiteCABA, Buenos Aires
  • Novartis Investigative SitePilar, Buenos Aires
  • Novartis Investigative SiteAuchenflower, Queensland
  • Novartis Investigative SiteSouth Brisbane, Queensland
  • Novartis Investigative SiteMontreal, Quebec
  • Novartis Investigative SiteSherbrooke, Quebec
  • Novartis Investigative SiteFuzhou, Fujian
  • Novartis Investigative SiteGuangzhou, Guangdong
  • Novartis Investigative SiteHarbin, Heilongjiang
  • Novartis Investigative SiteChangsha, Hunan
  • Novartis Investigative SiteShengyang, Liaoning

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 27, 2026. Always confirm current availability with the study team.

View original record ↗