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
Key facts
- Where
- Bron, Caen Cedex 5, Lyon, Marseille, Pessac, Quimper Cedex, Strasbourg Cedex és Villejuif, FranciaországSee the 8 sites
- Phase
- 2. fázis
Where in Franciaország
- Hospices Civils de LyonBron, FranciaországNo longer taking part
- Centre Francois BaclesseCaen Cedex 5, FranciaországNo longer taking part
- Centre Leon BerardLyon, FranciaországNo longer taking part
- Centre Hospitalier Regional De MarseilleMarseille, FranciaországNo longer taking part
- Centre Hospitalier Universitaire de BordeauxPessac, FranciaországNo longer taking part
- Centre Hospitalier Intercommunal De CornouailleQuimper Cedex, FranciaországNo longer taking part
- Les Hopitaux Universitaires De StrasbourgStrasbourg Cedex, FranciaországNo longer taking part
- Institut Gustave RoussyVillejuif, FranciaországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- F. Hoffmann-La Roche AG
- Trial code
- EU 2024-511239-91-00
- Record updated
- 2026. április 30.
- Original description
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 NSCLCRead full original descriptionShow less
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
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
Inclusion: 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.
Exclusion: Cohort B1: Prior exposure to any systemic anti-cancer therapy; Cohort B1:Prior exposure to any systemic anti-cancer therapy; Cohort B2: Any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post-major bowel resection; 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.