Locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer with a PD-L1 expression < 1% or a PD-L1 expression ≥ 1% and an STK11 co-mutation.
Conditions
Brief summary
Overall response rate (ORR), defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) as best overall response (BOR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by the investigator.
Detailed description
ORR per RECIST 1.1 as determined by the investigator, Type, frequency and severity of adverse events, changes in laboratory values, vital signs, electrocardiograms (ECGs)., Concentration of JDQ443 in plasma and derived PK parameters, as appropriate
Interventions
DRUGJDQ443
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR), defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) as best overall response (BOR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by the investigator. | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR per RECIST 1.1 as determined by the investigator, Type, frequency and severity of adverse events, changes in laboratory values, vital signs, electrocardiograms (ECGs)., Concentration of JDQ443 in plasma and derived PK parameters, as appropriate | — |
Countries
Austria, Belgium, France, Germany, Greece, Hungary, Italy, Netherlands, Portugal, Spain
Outcome results
None listed