Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT04667234
Eligibility Criteria:
Inclusion Criteria
* Age ≥ 18 years
* Ineligibility for participation in any Amgen-sponsored ongoing clinical study of the investigational product
* Pathologically documented, locally-advanced and unresectable or metastatic Non Small-Cell Lung Cancer (NSCLC) with KRAS p.G12C mutation confirmed through molecular testing
* Exhausted other standard of care options for locally advanced and unresectable or metastatic NSCLC disease including platinum-based combination chemotherapy and programmed cell death protein 1/programmed death-ligand 1 (PD 1/PD-L1) immunotherapy (unless medically contraindicated)
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
Exclusion Criteria
* Mixed small-cell lung cancer or mixed NSCLC histology
* Active brain metastases
* Active hepatitis B or hepatitis C virus
* Current active malignancy other than NSCLC
* Currently or previously enrolled in a prior sotorasib study unless radiographic disease progression confirmed, able to remain on long term follow up of their original protocol and receives medical monitor approval
* Female participants planning to become pregnant while on study through 7 days after the last dose of sotorasib
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT04667234
Study Brief:
Protocol Section:
NCT04667234