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: May 23, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

3

Condition

Non-small Cell Lung Cancer

Treatment

Alectinib

Carboplatin

Cisplatin

Clinical Study ID

NCT06624059
BO43249
  • Ages > 18
  • All Genders

Study Summary

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

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

Study Design

Total Participants: 150
Treatment Group(s): 4
Primary Treatment: Alectinib
Phase: 3
Study Start date:
November 18, 2024
Estimated Completion Date:
March 31, 2033

Connect with a study center

  • Royal North Shore Hospital

    Saint Leornards, New South Wales 2065
    Australia

    Site Not Available

  • Royal North Shore Hospital

    St. Leonards, New South Wales 2065
    Australia

    Active - Recruiting

  • Calvary Mater Newcastle

    Waratah, New South Wales 2298
    Australia

    Active - Recruiting

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande Do Sul 90610-000
    Brazil

    Active - Recruiting

  • Hospital de Cancer de Barretos

    Barretos, São Paulo 14784-400
    Brazil

    Active - Recruiting

  • Hospital de Base de Sao Jose do Rio Preto

    Sao Jose do Rio Preto, São Paulo 15090-000
    Brazil

    Active - Recruiting

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    Sao Paulo, São Paulo 01246-000
    Brazil

    Active - Recruiting

  • K2 Oncology

    Providencia, 7500000
    Chile

    Active - Recruiting

  • Centro de Estudios Clínicos SAGA

    Santiago, 7500653
    Chile

    Site Not Available

  • Inst. Nacional Del Cancer; Servicio de Oncologia Medica

    Santiago,
    Chile

    Site Not Available

  • OrlandiOncología

    Santiago, 7500713
    Chile

    Site Not Available

  • RedSalud Vitacura

    Santiago,
    Chile

    Active - Recruiting

  • James Lind Centro de Investigación Del Cáncer

    Temuco, 4800827
    Chile

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, 100142
    China

    Active - Recruiting

  • Xiangya Hospital of Centre-South University

    Changsha, 410008
    China

    Active - Recruiting

  • The third people's hospital of Chengdu

    Chengdu,
    China

    Active - Recruiting

  • Guangdong General Hospital

    Guangzhou, 510080
    China

    Active - Recruiting

  • Jinhua municipal central hospital

    Jinhua,
    China

    Active - Recruiting

  • Yunnan Cancer Hospital

    Kunming, 650118
    China

    Active - Recruiting

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan City, 430030
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Zhejiang, 310022
    China

    Active - Recruiting

  • Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia

    Perugia, Umbria 06156
    Italy

    Active - Recruiting

  • St. Vincent's Hospital

    Gyeonggi-do, 16247
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Hospital Regional Universitario Carlos Haya

    Malaga, 29010
    Spain

    Active - Recruiting

  • Oncology Unit, Faculty of Medicine, Vajira Hospital

    Dusit, 10300
    Thailand

    Active - Recruiting

  • Srinagarind Hospital

    Khon Kaen, 40002
    Thailand

    Active - Recruiting

  • Clinical Research Alliance

    Westbury, New York 11590
    United States

    Active - Recruiting

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