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

Last updated: July 1, 2026
Sponsor: Hoffmann-La Roche
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Non-small Cell Lung Cancer

Treatment

Cisplatin

Alectinib

Pemetrexed

Clinical Study ID

NCT06624059
BO43249
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 11
Treatment Group(s): 4
Primary Treatment: Cisplatin
Phase: 1/2
Study Start date:
November 18, 2024
Estimated Completion Date:
August 28, 2026

Connect with a study center

  • Royal North Shore Hospital

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande Do Sul 90610-000
    Brazil

    Active - Recruiting

  • Hospital de Clínicas de Porto Alegre X

    Porto Alegre, Rio Grande Do Sul DUMMY_VALUE
    Brazil

    Active - Recruiting

  • Hospital Sao Lucas - PUCRS

    Porto Alegre 3452925, Rio Grande do Sul 3451133 90610-000
    Brazil

    Site Not Available

  • Hospital de Clínicas de Porto Alegre X

    Porto Alegre 3452925, Rio Grande do Sul 3451133
    Brazil

    Active - Recruiting

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo 01246-000
    Brazil

    Site Not Available

  • Centro de Estudios Clínicos SAGA

    Santiago, 7500653
    Chile

    Site Not Available

  • Inst. Nacional Del Cancer; Servicio de Oncologia Medica

    Santiago,
    Chile

    Site Not Available

  • RedSalud Vitacura

    Santiago,
    Chile

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, 100142
    China

    Site Not Available

  • The third people's hospital of Chengdu

    Chengdu,
    China

    Site Not Available

  • Guangdong General Hospital

    Guangzhou, 510000
    China

    Site Not Available

  • Jinhua municipal central hospital

    Jinhua,
    China

    Site Not Available

  • Yunnan Cancer Hospital

    Kunming, 650118
    China

    Site Not Available

  • Irccs Istituto Europeo di Oncologia (IEO)

    Milano, Lombardia 20141
    Italy

    Active - Recruiting

  • Irccs Istituto Europeo di Oncologia (IEO)

    Milan 3173435, Lombardy 3174618 20141
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia

    Perugia, Umbria 06156
    Italy

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • ARKE Estudios Clínicos S.A. de C.V.

    Mexico City 3530597, 06700
    Mexico

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    South Korea

    Site Not Available

  • Asan Medical Center

    Seoul 1835848, 05505
    South Korea

    Site Not Available

  • Samsung Medical Center

    Seoul 1835848, 06351
    South Korea

    Site Not Available

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