Sotorasib for Advanced Non-Small Cell Lung Cancer
(CodeBreaK201 Trial)

Recruiting in Palo Alto (17 mi)

+72 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Amgen

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?The main objective of this study is to evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in participants who receive sotorasib at either 960 mg daily or 240 mg daily whose tumors are programmed death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) \< 1% and/or harbor a serine/threonine kinase 11 (STK11) co-mutation, in a subgroup of participants with PD-L1 \< 1% and in a subgroup of participants with STK11 co-mutation.

Eligibility Criteria

This trial is for adults with Stage IV NSCLC who have not been treated before, have a specific KRAS mutation (G12C), and either low PD-L1 levels or an STK11 co-mutation. They should be in good physical condition (ECOG score of 0 or 1) and cannot have had certain treatments within specified time frames.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

My cancer is at stage IV and I haven't received treatment for this stage yet.

My cancer has a PD-L1 score under 1% or an STK11 mutation.

+4 more

Exclusion Criteria

I have not had radiation therapy in the last 2 weeks.

I am not taking strong medications that affect liver enzymes or certain stomach acid drugs.

I have not had a heart attack in the last 6 months.

+3 more

Participant Groups

The study tests two doses of Sotorasib (960 mg daily or 240 mg daily) to see how well it works on tumors with low PD-L1 levels (<1%) and/or STK11 co-mutations. The effectiveness will be measured by the change in tumor size according to RECIST criteria.

2Treatment groups

Experimental Treatment

Group I: Sotorasib: 960 mg DailyExperimental Treatment1 Intervention

Participants with metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma (KRAS) p.G12C mutation whose tumors express \< 1% programmed death-ligand 1 (PD-L1) and/or serine/threonine kinase 11 (STK11) mutation in need of first line treatment will be administered sotorasib 960 mg daily. Participants will be stratified by known presence of STK11 mutation.

Group II: Sotorasib: 240 mg DailyExperimental Treatment1 Intervention

Participants with metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma (KRAS) p.G12C mutation whose tumors express \< 1% programmed death-ligand 1 (PD-L1) and/or serine/threonine kinase 11 (STK11) mutation in need of first line treatment will be administered sotorasib 240 mg daily. Participants will be stratified by known presence of STK11 mutation.

Sotorasib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Lumakras for: