NCT04933695CompletedPhase 2
Sotorasib (AMG 510) in Subjects with NSCLC with KRASG12C Mutation in Need of First-Line Treatment
A Phase 2, Multicenter, Open-label Study of Sotorasib (AMG 510) in Subjects with Stage IV NSCLC whose Tumors Harbor a KRASG12C Mutation in Need of First-Line Treatment (CodeBreak 201)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 21 Jul 2025
Brief summary (registry, in English)
To evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria in subjects who receive sotorasib at either 960mg daily (QD) or 240 mg QD 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 subjects with PD-L1 <1% and in a sub-group of subjects with STK11 co-mutation
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 23 (actual)
- First submitted
- 19 Apr 2024
- Start date
- 23 Dec 2021
- Lead sponsor
- Amgen Inc.
- Diseases
- Lung cancer
- NCT number
- NCT04933695
- EU CT number
- 2024-511189-36-00
- EudraCT number
- 2021-002638-18
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 23
- 7 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of proton-pump inhibitors (PPIs), histamine (H2) receptor antagonistes (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
Other illness
- Mixed small-cell lung cancer and NSCLC histology.
- Myocardial infarction within 6 months of study day 1
Other
- Active brain metastases from non-brain tumors
- Unable to receive both iodinated contrast for computed tomorgraphy (CT) scans and gadolinium contrast for magnetic resonance imagine (MRI) scans
Who the study is looking for
- Adult 18 years or older with NSCLC
- Untreated Stage IV metastatic disease. Participants who received adjubant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed greter than 12 months prior to the deveolpment of metastatic disease
- Pathologically documented metastatic NSCLC with KRAS G12C mutation (local confirmation)
- Programmed death-ligand 1 (PD0L1) TPS Score less than 1 percent and or serine threonine kinase 11 (STK11) co-mutation (local confirmation)
- Eastern Cooperatiove 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
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Completed |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Completed |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Completed |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Region Gaevleborg Coordinator of this site? Confirm its status | Gavle | Sweden | Completed |
| Sahlgrenska University Hospital-Vaestra Goetalandsregionen Coordinator of this site? Confirm its status | Goteborg | Sweden | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.