NCT05853575RecruitingPhase 2
Trial of Two Adagrasib Dosing Regimens in NSCLC with KRAS G12C Mutation
A Randomized Study of Two Dosing Regimens of Adagrasib in Patients with Previously Treated Non-Small Cell Lung Cancer with KRAS G12C Mutation
Source: EU CTIS (euclinicaltrials.eu) · Last updated 25 Sept 2026
Brief summary (registry, in English)
To evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID without regard to food versus 400 mg BID with food) in patients with NSCLC with KRAS G12C mutation and who have received prior treatment with a platinum-based regimen and immune checkpoint inhibitor therapy.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 267 (estimated)
- First submitted
- 25 May 2023
- Start date
- 29 Feb 2024
- Lead sponsor
- Mirati Therapeutics Inc.
- Diseases
- Lung cancer
- NCT number
- NCT05853575
- EU CT number
- 2023-503523-25-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 267
- 51 sites in 9 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
- Have had previous treatment with a drug that targets KRAS G12C.
Other illness
- Have cancer that can potentially be removed with surgery.
- Have certain medical conditions or need to take certain medications that, in the opinion of a trial doctor, could make it unsafe for them to participate or difficult to complete the trial assessments, or are pregnant.
Who the study is looking for
- Are at least 18 years old (or old enough to legally make their own treatment decisions, according to local laws).
- Have advanced NSCLC or metastatic NSCLC (NSCLC that started in the lungs and then spread to other parts of the body) with the KRAS G12C mutation.
- Have had previous treatment with 1) chemotherapy that included a drug called cisplatin or a drug called carboplatin and 2) a type of drug called an immune checkpoint inhibitor.
- Have recovered from their prior treatment and blood tests are within a safe range.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (51)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitari Dexeus Grupo Quironsalud Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| University Hospital Son Espases Coordinator of this site? Confirm its status | Palma | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Active, not recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Centre Hospitalier Universitaire D'Angers Coordinator of this site? Confirm its status | Angers | France | Active, not recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Active, not recruiting |
| Groupe Hospitalier Bretagne Sud Coordinator of this site? Confirm its status | Lorient | France | Active, not recruiting |
| Assistance Publique Hôpitaux de Marseille Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Active, not recruiting |
| GIE Groupe hospitalier Paris Saint-Joseph/Vinci Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Active, not recruiting |
| Centre Hospitalier Intercommunal De Cornouaille Coordinator of this site? Confirm its status | Quimper Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Active, not recruiting |
| Direction Centrale Du Service De Sante Des Armees Coordinator of this site? Confirm its status | Saint-Mande | France | Active, not recruiting |
| Institut De Cancerologie De L Ouest Coordinator of this site? Confirm its status | St Herblain | France | Active, not recruiting |
| Les Hopitaux Nord-Ouest Coordinator of this site? Confirm its status | Villefranche Sur Saone Cedex | France | Active, not recruiting |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| Alexandra Hospital Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| General Hospital Of Thessaloniki Papageorgiou Coordinator of this site? Confirm its status | Efkarpia | Greece | Active, not recruiting |
| General University Hospital Of Patras Coordinator of this site? Confirm its status | Patras | Greece | Active, not recruiting |
| Theageneio Cancer Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Active, not recruiting |
| St. Luke's Hospital S.A. Coordinator of this site? Confirm its status | Thessaloniki | Greece | Active, not recruiting |
| Klinicki bolnicki centar Sestre milosrdnice Coordinator of this site? Confirm its status | Grad Zagreb | Croatia | Completed |
| Specijalna Bolnica Medico Coordinator of this site? Confirm its status | Rijeka | Croatia | Completed |
| University Hospital Center Zagreb Coordinator of this site? Confirm its status | Zagreb | Croatia | Completed |
| Koranyi National Institute For Pulmonology Coordinator of this site? Confirm its status | Budapest XII | Hungary | Completed |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Completed |
| Istituto Europeo di Oncologia s.r.l Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Maggiore della Carità Coordinator of this site? Confirm its status | Novara | Italy | Active, not recruiting |
| University Hospital Of Perugia Coordinator of this site? Confirm its status | Perugia | Italy | Active, not recruiting |
| Azienda Sanitaria Territoriale Pesaro Urbino (AST PU) Coordinator of this site? Confirm its status | Pesaro | Italy | Active, not recruiting |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Netherlands Cancer Institute Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Active, not recruiting |
| St. Antonius Ziekenhuis Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Active, not recruiting |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Szpitale Pomorskie Sp z o o Coordinator of this site? Confirm its status | Gdynia | Poland | Completed |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| MS Pneumed - Janusz Milanowski, Katarzyna Szmygin-Milanowska Spolka Jawna Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Medisprof S.R.L. Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Completed |
| Oncolab S.R.L. Coordinator of this site? Confirm its status | Craiova | Romania | Completed |
| Centrul De Oncologie SF Nectarie S.R.L. Coordinator of this site? Confirm its status | Craiova | Romania | Completed |
| Ovidius Clinical Hospital S.R.L Coordinator of this site? Confirm its status | Ovidiu | Romania | Completed |
| Spitalul Clinic Judetean de Urgenta Sibiu Coordinator of this site? Confirm its status | Sibiu | Romania | Completed |
| Sigmedical Services S.R.L. Coordinator of this site? Confirm its status | Suceava | Romania | Completed |
| Oncocenter Oncologie Clinica S.R.L Coordinator of this site? Confirm its status | Timișoara | Romania | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.