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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 25, 2026 · Source: ClinicalTrials.gov
The study is underway but is not accepting new participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Novartis Pharmaceuticals
- Interventions being studied
- Drug: JDQ443; Drug: docetaxel
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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/
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
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: Sep 25, 2026. Always confirm current availability with the study team.