Overview
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.
Eligibility
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