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

NCT06624059

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Non-Small Cell Lung Cancer

Interventions: Alectinib, Cisplatin, Carboplatin, Pemetrexed

Countries: Australia, Brazil, Chile, China, Italy, South Korea

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (11)

St Leonards, New South Wales, Australia
Nedlands, Western Australia, Australia
São Paulo, São Paulo, Brazil
Santiago, Chile
Beijing, China
Chengdu, China
Guangzhou, China
Jinhua, China
Kunming, China
Perugia, Umbria, Italy
Seoul, South Korea