NCT05132075Active, not recruitingPhase 3
Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer
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
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 95 (actual)
- First submitted
- 11 Nov 2021
- Start date
- 15 Jun 2022
- Primary completion date
- 3 Sept 2026
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Lung cancer
- NCT number
- NCT05132075
- EU CT number
- 2023-510082-10-00
- EudraCT number
- 2021-002605-10
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 95
- From 15 Jun 2022 to the primary completion date, 3 Sept 2026
- 47 sites in 25 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Participant has an history of interstitial lung disease or pneumonitis grade \> 1.
- Other inclusion/exclusion criteria may apply
Lab values
- 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.
Other
- Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (47)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.