Unresectable stage III (IIIA-N2, IIIB, IIIC) KRAS p.G12C non-small cell lung cancer
Conditions
Brief summary
"Primary-PFS will be defined as the time from the date of first dose of induction treatment until the date of first objective disease progression or death. The PFS6 will be defined as the Kaplan-Meier estimate of PFS at 6 months. Progression will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1"
Detailed description
1. Overall response rate (ORR) is defined as the proportion of patients who have a partial or complete response to therapy; it does not include stable disease and is a direct measure of drug tumoricidal activity., 2. Overall Survival (OS) rate of live patients from enrollment until 6 months, 1 year and 2 years of treatment., 3. Sites of first failure, 4. To evaluate the safety and tolerability of AMG510 (Sotorasib), 5. To evaluate number of patients that become resectable after induction treatment
Interventions
Sponsors
Fundacion GECP
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| "Primary-PFS will be defined as the time from the date of first dose of induction treatment until the date of first objective disease progression or death. The PFS6 will be defined as the Kaplan-Meier estimate of PFS at 6 months. Progression will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1" | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall response rate (ORR) is defined as the proportion of patients who have a partial or complete response to therapy; it does not include stable disease and is a direct measure of drug tumoricidal activity., 2. Overall Survival (OS) rate of live patients from enrollment until 6 months, 1 year and 2 years of treatment., 3. Sites of first failure, 4. To evaluate the safety and tolerability of AMG510 (Sotorasib), 5. To evaluate number of patients that become resectable after induction treatment | — |
Countries
Spain
Outcome results
None listed