A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment (CodeBreaK201)

  • STATUS
    Recruiting
  • End date
    Feb 21, 2028
  • participants needed
    170
  • sponsor
    Amgen
Updated on 30 June 2022
measurable disease
KRAS
brain metastases
STK11
LKB1

Summary

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.

Details
Condition Non-small Cell Lung Cancer
Treatment Sotorasib
Clinical Study IdentifierNCT04933695
SponsorAmgen
Last Modified on30 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult (= or > 18 years old) with NSCLC
Untreated Stage IV metastatic disease. Participants who received adjuvant or neoadjuvant anti-tumor therapy are eligible if the adjuvant/neoadjuvant therapy was completed greater than 12 months prior to the development of metastatic stage IV disease
Pathologically documented metastatic NSCLC with KRAS G12C mutation (local confirmation)
Programmed death-ligand 1 (PD-L1) TPS Score < 1% and/or serine/threonine kinase 11 (STK11) co-mutation (local confirmation)
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
No active brain metastases
Measurable disease per investigator interpretation using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

Exclusion Criteria

Mixed small-cell lung cancer and NSCLC histology
Myocardial Infarction within 6 months of study Day 1
Use of proton-pump inhibitors (PPIs), histamine (H2) receptor antagonists (H2RA), strong inducers of cytochrome P450 (CYP) 3A4 (CYP3A4) or known CYP3A4 sensitive substrates or P-gp substrates
Therapeutic or palliative radiation therapy within 2 weeks of study day 1
Unable to take oral medication
Unable to receive both iodinated contrast for computed tomography (CT) scans and gadolinium contrast for magnetic resonance imagine (MRI) scans
Clear my responses

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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