Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation
Advanced NSCLC, Metastatic Lung Cancer
About this trial
This is an interventional treatment trial for Advanced NSCLC focused on measuring KRAS G12C, NSCLC, Non Small Cell Lung Cancer
Eligibility Criteria
Cohort A* (closed): Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (squamous or nonsquamous) KRASG12C mutation and histologically confirmed PD-L1 TPS ≥1%. Cohort C: Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1 TPS < 50% AND previously completed 4 cycles of standard-of-care platinum based induction chemotherapy with pembrolizumab AND experienced stable disease, partial response, or complete response per investigator's assessment after 4 cycles OR if patients received <4 cycles of a platinum-based induction, was stopped early due to intolerable toxicity Cohort E: Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1 TPS < 50% Presence of measurable disease per RECIST v1.1 Exclusion Criteria: All Cohorts: Any prior therapy targeting KRASG12C mutation in any setting Cohorts A & E: Prior systemic therapy for locally advanced or metastatic NSCLC, including chemotherapy, immune checkpoint inhibitor therapy or chemoimmunotherapy (note: prior systemic therapy or chemoradiation given in the adjuvant or neoadjuvant setting are allowed if last dose of prior systemic treatment was >1 year prior to first dose of study treatment) Cohort C: received maintenance therapy (e.g, pembrolizumab and/or pemetrexed following completion of 4-6 cycles of a platinum-based regimen administered in the first-line setting Radiation to the lung > 30 Gy within 6 months prior to first dose of study treatment Active brain metastases
Sites / Locations
- MemorialCare - Orange Coast Medical CenterRecruiting
- MemorialCare - OC Blood and Cancer CenterRecruiting
- USOR - Rocky Mountain Cancer Centers - Denver - Rose Medical Center CampusRecruiting
- The Oncology Institute of Hope and InnovationRecruiting
- UKCC - Westwood/Richard and Annette Bloch Cancer Care PavilionRecruiting
- Henry Ford Cancer InstituteRecruiting
- Mayo ClinicRecruiting
- Hematology Oncology Associates of CNY, PCRecruiting
- New York Cancer & Blood SpecialistsRecruiting
- Cleveland ClinicRecruiting
- Texas Oncology NortheastRecruiting
- Texas Oncology - Baylor Charles A. Sammons Cancer CenterRecruiting
- NEXT VirginiaRecruiting
- PeaceHealth St. Joseph Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Cohort A: PD-L1 TPS≥ 1% (Closed)
Cohort C
Cohort E
Adagrasib 400 mg BID for 2 cycles followed by adagrasib 400 mg BID + pembrolizumab 200 mg every 3 weeks (Q3W) up to 35 cycles
Adagrasib 400 mg BID + pemetrexed 500 mg/m2 Q3W + pembrolizumab 200 mg Q3W up to 31 cycles
Adagrasib 400 mg BID + pembrolizumab 200 mg Q3W + pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 Q3W OR carboplatin AUC 5 Q3W for 4 cycles, followed by adagrasib 400 mg BID + pemetrexed 500 mg/m2 Q3W + pembrolizumab 200 mg Q3W (up to 31 cycles)