Clinical Trial: NCT05132075
Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Novartis Pharmaceuticals |
| Information Provided By: | Novartis |
| Last Update Posted: | 2026-09-25 |
Study Overview
Brief Summary
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.
Official Title
A Randomized, Controlled, Open Label, Phase III Study Evaluating the Efficacy and Safety of JDQ443 Versus Docetaxel in Previously Treated Subjects With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer
Conditions
Non-Small Cell Lung Cancer
Intervention / Treatment
- Drug: JDQ443
- Drug: docetaxel
Other Study ID Numbers
- CJDQ443B12301
- 2023-510082-10-00
- 2023
Start Date (Actual)
2022-06-15
Primary Completion Date (Actual)
2026-09-03
Study Completion Date (Estimated)
2026-10-03
Enrollment (Actual)
95
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Novartis Pharmaceuticals |
| Information Provided By: | Novartis |
| Last Update Posted: | 2026-09-25 |
Study Overview
Brief Summary
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.
Official Title
A Randomized, Controlled, Open Label, Phase III Study Evaluating the Efficacy and Safety of JDQ443 Versus Docetaxel in Previously Treated Subjects With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer
Conditions
Non-Small Cell Lung Cancer
Intervention / Treatment
- Drug: JDQ443
- Drug: docetaxel
Other Study ID Numbers
- CJDQ443B12301
- 2023-510082-10-00
- 2023
Start Date (Actual)
2022-06-15
Primary Completion Date (Actual)
2026-09-03
Study Completion Date (Estimated)
2026-10-03
Enrollment (Actual)
95
Study Type
Interventional
Phase
Phase 3