Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18+
Clinical summary
Summary
Eligible participants will be allocated to one of two cohorts based on their diagnosis and treatment history.
Cohort B1 will enrol people with primary non-small cell lung cancer that has been completely resected (removed with surgery). This cohort is a phase II cohort that will evaluate the safety and efficacy of alectinib in combination with up to four cycles of platinum-based chemotherapy in the adjuvant setting post complete surgical resection.
Cohort B2 will enrol people with non-small cell lung cancer that is able to be removed with surgery. It is a phase II cohort that will evaluate the efficacy and safety of perioperative alectinib in combination with chemotherapy in the neoadjuvant setting.
Conditions
This trial is treating people with early stage (stage II to select stage IIIB) non-squamous non-small cell lung cancer with ALK fusion
Eligibility
Inclusion
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:
Exclusion
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
Inclusion
- Your cancer has not spread to other parts of the body (localised).
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Hoffmann-La Roche
Scientific Title
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
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