NCT05132075phase 3active not recruiting

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

Novartis Pharmaceuticals

ClinicalTrials.gov

Enrollment · actual

Countries · 51 sites

2026-08

Primary completion

13 days ago

Record updated

Commercial relevance

Trial record references molecular eligibility required, central lab testing referenced.

Molecular eligibility requiredCentral lab testing

Biomarker requirement language

Participant has histologically confirmed locally advanced/metastatic (stage IIIB/IIIC or IV)
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.

Change timeline

No changes detected yet. The first refresh records a baseline snapshot; subsequent refreshes generate field-level changes.

Signals from this trial

New trial
56/100
Opportunity
New phase 3 trial NCT05132075 posted by Novartis Pharmaceuticals: "Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer".
ClinicalTrials.gov record updated 12 days ago.

Eligibility — raw, for validation

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