A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC). The objective of this study is to evaluate the efficacy and/or safety of multiple therapies in patients with early-stage resectable NSCLC.
Cohort B1 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 is a phase II cohort that will evaluate the efficacy and safety of perioperative alectinib in combination with chemotherapy in the neoadjuvant setting.
Detailed eligibility criteria is available on ClinicalTrials.gov. These requirements will be discussed with your doctor and/or study representative. ClinicalTrials.gov to learn more about this study. 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
Protocol Number: 25-0825
More information available at ClinicalTrials.gov: NCT06624059
Principal Investigator