Clinical trial · Expanded Access
Expanded Access of Sotorasib
A Multicenter, Open-label, Single-arm, Expanded Access Protocol of Sotorasib for the Treatment of Subjects With Previously Treated Locally Advanced Unresectable/Metastatic NSCLC With KRAS p.G12C Mutation
NCT04667234CI-TRIAL-00122944no longer availableClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Metastatic NSCLC | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Locally Advanced Unresectable NSCLC | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Non Small-cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 510 | Drug | Sotorasib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDNovello S, Rabinovich NM, Shih JY, Pelizzari G, Stevenson J, Majem M, Ferreira CG, Petty WJ, Arriola E, Castagneris N, De Castro J, Morbeck I, Bauman J, Toschi L, Zer A, Metro G, Kalmadi S, Martinez AA, Al Husaini H, Meloni AR, Nduka C, Ardito-Abraham C, Xia C, Awad MM. Sotorasib in Advanced KRAS G12C-Mutated NSCLC: Results From the Global Expanded Access Program, Including Patients With Poor Performance Status and a History of CNS Metastases. JTO Clin Res Rep. 2026 Feb 13;7(5):100974. doi: 10.1016/j.jtocrr.2026.100974. eCollection 2026 May. PMID 42006282