Active — Not RecruitingPhase 1/2

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

Australia, Brazil, Chile11 participantsStarted 2024-11-18

Plain-language summary

The objective of this study is to explore the safety of alectinib in combination with chemotherapy in participants with resectable NSCLC. Cohort B1 is a phase II cohort that will assess the safety of alectinib in combination with up to four cycles of platinum-based chemotherapy in the adjuvant setting post complete surgical resection.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * Documented ALK fusion Exclusion Criteria: * NSCLC of squamous or mixed histology regardless of the presence of an ALK mutation * Prior exposure to any systemic anti-cancer therapy * Pregnancy or breastfeeding, or intention of becoming pregnant during the study

What they're measuring

Incidence, Type, and Severity of Adverse Events (AEs) With Onset up to 28 Days After the Last Dose of Chemotherapy

Timeframe: Up to 28 days after the last dose of chemotherapy treatment (up to 4 cycles, cycle length = 3 weeks)

Trial details

NCT IDNCT06624059

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-28

View on ClinicalTrials.gov More Non-Small Cell Lung Cancer trials