Expanded Access of Sotorasib

Amgen

Status

Conditions: Non Small-cell Lung Cancer; Locally Advanced Metastatic NSCLC; Locally Advanced Unresectable NSCLC

Treatments: Drug: AMG 510

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT04667234

20190436

Details and patient eligibility

About

The primary objective of this study is to provide expanded access to and characterize the safety profile of Sotorasib in participants with previously treated locally advanced/unresectable/metastatic non small-cell lung cancer (NSCLC) with KRAS p.G12C mutation in a real-world setting.

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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