Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer
- Conditions
- on-Small Cell Lung Cancernon-small cell lung cancer
- Registration Number
- LBCTR2022055019
- Lead Sponsor
- ovartis Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 8
Participant has histologically confirmed locally advanced/metastatic (stage IIIB/IIIC or IV)
- Participant has a KRAS G12C mutation present in tumor tissue prior to enrollment, as determined by a Novartis designated central laboratory.
- 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.
- Participant has previously received docetaxel, KRAS G12C inhibitor or any other systemic therapy for their locally advanced or metastatic NSCLC other than one platinum-based chemotherapy and one prior immune check point inhibitor
- Participant has EGFR-sensitizing mutation and/or ALK rearrangement by local laboratory testing
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ame: Progression free survival (PFS);Timepoints: Approximately up to 24 months;Measure: PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. PFS is based on central assessment and using RECIST 1.1 criteria
- Secondary Outcome Measures
Name Time Method