Evaluating treatments for early-stage non-small cell lung cancer
A Phase I-III, 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
This study is testing different treatment options for people with early-stage non-small cell lung cancer to see which ones work best and are safe after or before surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Drugs / interventions | alectinib, chemotherapy |
| Locations | 27 sites (Westbury, New York and 26 other locations) |
| Trial ID | NCT06624059 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy and safety of various therapies in patients with early-stage resectable non-small cell lung cancer (NSCLC). It includes two cohorts: one evaluating alectinib combined with platinum-based chemotherapy after surgical resection, and another assessing the same combination in the neoadjuvant setting before surgery. Participants will be closely monitored for treatment outcomes and safety profiles. The study focuses on patients with specific histological types of NSCLC and documented ALK fusion.
Who should consider this trial
Good fit: Ideal candidates are patients with stage II to select stage IIIB non-squamous NSCLC who have undergone complete surgical resection.
Not a fit: Patients with squamous or mixed histology NSCLC or those who have previously received systemic anti-cancer therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new effective treatment options for patients with early-stage non-small cell lung cancer.
How similar studies have performed: Other studies have shown promise in using targeted therapies like alectinib for NSCLC, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria Cohort B1: * Complete resection of the primary NSCLC with negative margins * Confirmed stage II to select stage IIIB (T3N2) NSCLC of non-squamous (adenocarcinoma) histology * Eastern cooperative oncology group (ECOG) performance status of 0 or 1 Inclusion Criteria 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 * Pathologically and/or histologically confirmed Stage II-IIIA and IIIB (T3N2 only) NSCLC of non-squamous (adenocarcinoma) histology Inclusion Criteria Cohorts B1 and B2: * Documented ALK fusion Exclusion Criteria Cohort B1: * NSCLC of squamous or mixed histology regardless of the presence of an ALK mutation * Prior exposure to any systemic anti-cancer therapy Exclusion Criteria Cohort B2: * NSCLC of squamous or mixed histology regardless of the presence of an ALK mutation * Known sensitivity to any component of alectinib, pemetrexed, cisplatin, or carboplatin * Prior exposure to any systemic anti-cancer therapy Exclusion Criteria Cohorts B1 and B2: * Pregnancy or breastfeeding, or intention of becoming pregnant during the study
Where this trial is running
Westbury, New York and 26 other locations
- Clinical Research Alliance — Westbury, New York, United States (Recruiting)
- Royal North Shore Hospital — St. Leonards, New South Wales, Australia (Recruiting)
- Calvary Mater Newcastle — Waratah, New South Wales, Australia (Recruiting)
- Peter Maccallum Cancer Centre — Melbourne, Victoria, Australia (Recruiting)
- Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia (Recruiting)
- Hospital Sao Lucas - PUCRS — Porto Alegre, Rio Grande Do Sul, Brazil (Recruiting)
- Hospital de Cancer de Barretos — Barretos, São Paulo, Brazil (Recruiting)
- Hospital de Base de Sao Jose do Rio Preto — Sao Jose do Rio Preto, São Paulo, Brazil (Recruiting)
- Instituto do Cancer do Estado de Sao Paulo - ICESP — Sao Paulo, São Paulo, Brazil (Recruiting)
- K2 Oncology — Providencia, Chile (Recruiting)
- RedSalud Vitacura — Santiago, Chile (Recruiting)
- Beijing Cancer Hospital — Beijing, China (Recruiting)
- Xiangya Hospital of Centre-South University — Changsha, China (Recruiting)
- The third people's hospital of Chengdu — Chengdu, China (Recruiting)
- Guangdong General Hospital — Guangzhou, China (Recruiting)
- Jinhua municipal central hospital — Jinhua, China (Recruiting)
- Yunnan Cancer Hospital — Kunming, China (Recruiting)
- Tongji Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan City, China (Recruiting)
- Zhejiang Cancer Hospital — Zhejiang, China (Recruiting)
- Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia — Perugia, Umbria, Italy (Recruiting)
- St. Vincent's Hospital — Gyeonggi-do, Korea, Republic of (Recruiting)
- Severance Hospital, Yonsei University Health System — Seoul, Korea, Republic of (Recruiting)
- Asan Medical Center — Seoul, Korea, Republic of (Recruiting)
- Samsung Medical Center — Seoul, Korea, Republic of (Recruiting)
- Hospital Regional Universitario Carlos Haya — Malaga, Spain (Recruiting)
- Oncology Unit, Faculty of Medicine, Vajira Hospital — Dusit, Thailand (Recruiting)
- Srinagarind Hospital — Khon Kaen, Thailand (Recruiting)
Study contacts
- Study coordinator: Reference Study ID Number: BO43249 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.