Study on the Safety and Effectiveness of Different Treatments for Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Hoffmann-La Roche

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06624059

Provider View

This clinical trial is exploring how well and how safely different treatment combinations work for patients with early-stage Non-Small Cell Lung Cancer (NSCLC) that can be surgically removed. The study includes two groups: one receiving alectinib with chemotherapy after surgery, and another receiving the combination before surgery.

Patient Parameters

Program Overview

The purpose of this study is to find out how effective and safe different treatments are for patients with early-stage Non-Small Cell Lung Cancer (NSCLC) that can be surgically removed. The study has two parts: one part will test the safety and effectiveness of alectinib combined with chemotherapy after surgery, and the other part will test the combination before surgery. This will help determine the best approach to treating NSCLC in these patients.

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

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