2024-511239-91-00CompletedPhase 2
A Study to see How Well and How Safely Different Treatments Work in a Group of Patients with Non-Small Cell Lung Cancer, Chosen Based on their Biomarker Status
A Phase I-II, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients with Resectable Stage I-III Non-Small Cell Lung Cancer, selected according to Biomarker Status
Source: EU CTIS (euclinicaltrials.eu) · Last updated 30 Apr 2026
Brief summary (registry, in English)
The objective of this study was to evaluate the efficacy and/or safety of multiple therapies in patients with early-stage resectable NSCLC. Following the study’s early closure, the objectives for cohort B1 have changed. The objectives for cohort B2 remain unchanged as no participants were enrolled in that cohort or are planned to be enrolled in that cohort. Cohort B1: To explore the safety of alectinib in combination with chemotherapy in patients with completely resected Stage II, IIIA, and selected IIIB (T3N2 only; as per AJCC eighth edition), anaplastic lymphoma kinase (ALK)-positive NSCLC Cohort B2:To evaluate the efficacy of neoadjuvant treatment with alectinib in combination with chemotherapy in patients with resectable Stage II, IIIA, and selected IIIB (T3N2 only; as per AJCC, Eighth Edition), ALK-positive NSCLC
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 54 (actual)
- First submitted
- 25 Oct 2024
- Start date
- 5 May 2025
- Lead sponsor
- F. Hoffmann-La Roche AG
- Diseases
- Lung cancer
- EU CT number
- 2024-511239-91-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 54
- 31 sites in 8 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 design.
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
- Cohort B1: Prior exposure to any systemic anti-cancer therapy
- Cohort B1:Prior exposure to any systemic anti-cancer therapy
Other illness
- Cohort B2: Any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post-major bowel resection
Other
- Cohort B1: NSCLC of squamous or mixed histology regardless of the presence of an ALK mutation
- Cohort B1 and B2: Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- Cohort B2: Known sensitivity to any component of alectinib, pemetrexed, cisplatin, or carboplatin
Who the study is looking for
- Cohort B1: Complete resection of the primary NSCLC with negative margins
- Cohort B1: Confirmed stage II-select IIIB (T3N2) NSCLC of non-squamous (adenocarcinoma) histology
- Cohort B1: ECOG performance status of 0 or 1
- Cohort B2: Evaluation by the operating attending surgeon and involved medical oncologist prior to study enrollment to verify study eligibility for complete surgical resection with curative intent
- Cohort B2: Pathologically and/or histologically confirmed Stage II-IIIA and IIIB (T3N2 only) NSCLC of non-squamous (adenocarcinoma) histology
- Cohort B1 and B2: Documented ALK fusion
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (31)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stadt Wien Wiener Gesundheitsverbund | Vienna | Austria | Completed |
| UZ Leuven | Leuven | Belgium | Completed |
| Cliniques Universitaires Saint-Luc | Sint-Lambrechts-Woluwe | Belgium | Completed |
| Rigshospitalet | Copenhagen Oe | Denmark | Completed |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Completed |
| Institut Catala D'oncologia | L'Hospitalet de Llobregat | Spain | Completed |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Completed |
| Hospital Universitario Regional de Málaga | Málaga | Spain | Completed |
| Hospital Clinico Universitario de Valencia | Valencia | Spain | Completed |
| Hospices Civils de Lyon | Bron | France | Completed |
| Centre Francois Baclesse | Caen Cedex 5 | France | Completed |
| Centre Leon Berard | Lyon | France | Completed |
| Centre Hospitalier Regional De Marseille | Marseille | France | Completed |
| Centre Hospitalier Universitaire de Bordeaux | Pessac | France | Completed |
| Centre Hospitalier Intercommunal De Cornouaille | Quimper Cedex | France | Completed |
| Les Hopitaux Universitaires De Strasbourg | Strasbourg Cedex | France | Completed |
| Institut Gustave Roussy | Villejuif | France | Completed |
| Istituto Tumori Bari Giovanni Paolo II | Bari | Italy | Completed |
| Cliniche Gavazzeni S.p.A. | Bergamo | Italy | Completed |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l | Meldola | Italy | Completed |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | Italy | Completed |
| Istituto Europeo di Oncologia s.r.l | Milan | Italy | Completed |
| Istituto Oncologico Veneto | Padova | Italy | Completed |
| Hospital Santa Maria Della Misericordia | Perugia | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Italy | Completed |
| Amsterdam UMC Stichting | Amsterdam | Netherlands | Completed |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | Completed |
| Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow | Poznan | Poland | Completed |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy | Warsaw | Poland | Completed |
| Centrum Pulmonologii I Torakochirurgii W Bystrej | Wilkowice | Poland | Completed |
| Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii | Wroclaw | Poland | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.