A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Hoffmann-La Roche

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06624059

Patient View

This study evaluates the safety and efficacy of alectinib with chemotherapy in early-stage resectable NSCLC. Cohort B1 involves adjuvant alectinib with up to four cycles of platinum-based chemotherapy post-surgery. Cohort B2 assesses perioperative alectinib with chemotherapy pre-surgery. Participants receive alectinib orally and cisplatin, carboplatin, and pemetrexed intravenously.

Patient Parameters

Program 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 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

Get This Program In Your Inbox

You can sign up and apply your patients for this program.