Previously Treated Locally Advanced and Unresectable or Metastatic Non-small Cell Lung Cancer with KRAS p.G12C Mutation MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: AMG 510
Product Code: [AMG 510]
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Sotorasib
Current Sponsor code: AMG 510
Concentration unit: mg milligram(s)
Concentration typ
Sponsors
AMGEN INC.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject has provided informed consent prior to initiation of any study specific activities/procedures. - Age >= 18 years. - Pathologically documented, locally-advanced, and unresectable or metastatic non-small cell lung cancer. - Have documentation of KRAS p.G12C mutation per local testing guidelines or a screening for another Amgen sotorasib study. - Subject has exhausted other standard of care options for locally advanced and unresectable or metastatic disease including platinum-based combination chemotherapy, PD-1/PD-L1 immunotherapy, and docetaxel (unless contraindicated). - Eastern Cooperative Oncology Group (ECOG) performance status =65 years) yes F.1.3.1 Number of subjects for this age range 263
Exclusion criteria
Exclusion criteria: - Mixed small-cell lung cancer and NSCLC histology - Subjects with symptomatic CNS metastases who are neurologically unstable or have required increasing doses of steroids to manage CNS symptoms within the 2 weeks prior to study day 1 Other Medical Conditions - Subjects with active hepatitis B (positive hepatitis B surface antigen [HBsAg]) or hepatitis C virus (HCV) (positive HCV RNA) - Subjects with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HBsAg) are eligible - HBV carriers or those subjects receiving antiviral therapy for HBV or HCV are not eligible to participate - Subjects positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA - Current active malignancy other than NSCLC with the exception of those with a negligible risk of metastases or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal cell carcinoma, cutaneous squamous cell carcinoma, localized prostate cancer treated with curative intent, or ductal carcinoma in situ treated surgically with curative intent). - Leptomeningeal disease *Please refer to the protocol for the full list
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To provide expanded access and to characterize the safety profile of sotorasib in subjects with previously treated locally advanced unresectable/metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C mutation;Secondary Objective: - To describe and collect testing modalities in KRAS p.G12C-positive NSCLC subjects - To evaluate the duration of treatment with sotorasib;Primary end point(s): Incidence of treatment-emergent adverse events (TEAE), adverse event of interest, treatment-related adverse events, serious TEAE, TEAE leading to discontinuation of sotorasib;Timepoint(s) of evaluation of this end point: The exact timing of the primary analysis will be based on subject enrollment and will occur after sotorasib receives marketing authorization approval for the treatment of NSCLC for all participating countries in which subjects were enrolled. A final analysis will occur when all enrolled subjects have completed the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - KRAS p.G12C testing modalities - Treatment duration;Timepoint(s) of evaluation of this end point: The exact timing of the primary analysis will be based on subject enrollment and will occur after sotorasib receives marketing authorization approval for the treatment of NSCLC for all participating countries in which subjects were enrolled. A final analysis will occur when all enrolled subjects have completed the study. | — |
Countries
Italy, Spain, Switzerland
Contacts
Public ContactMedical Information
Amgen S.r.l.
Outcome results
None listed