A Phase II Study of Sotorasib in Participants with Previously Treated Stage IV or Recurrent KRAS G12C Mutated Non-Squamous Non-Small Cell Lung Cancer

Protocol: SWOG – S1900E

SCHEMA S1900E

Please Note:  Below is partial eligibility, for full eligibility requirement’s, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or   (810) 762-8038. Thank you!

Eligibility:  Sub-Study of Lung Map

1. Participants must have confirmed Stage IV or recurrent non-squamous non-small cell lung cancer (NSCLC). Mixed histology NSCLC with less than 50% squamous component is allowed.
2. Participants must have measurable disease. Measurable disease must be assessed within 28 days prior to sub-study registration.
3. Participants must have a CT or MRI scan of the brain to evaluate for CNS disease within 42 days prior to sub-study registration.
4. Participants with EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS1 gene rearrangement, or BRAF V600E mutation must have progressed following all standard of care targeted therapy.
5. Participants must have received at least one line of systemic treatment for Stage IV or recurrent NSCLC.
6. Participants must have progressed (in the opinion of the treating physician) following the most recent line of systemic therapy for NSCLC.
7. Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub study registration.
8. Participants must not have received any radiation therapy within 14 days prior to sub-study registration, with the exception of stereotactic radiation to CNS metastases which must have been completed at least 7 days prior to sub-study
   registration.
9. Participants must not have received prior sotorasib (AMG 510) or other KRASG12C specific inhibitor.
10. Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study.
11. Participants must not have had a major surgery within 14 days prior to sub-study registration.
12. Participants must be able to swallow tablets whole.
13.  Zubrod performance status must be 0-1.
14. Participants must not have a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.