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: January 19, 2026
Sponsor: Hoffmann-La Roche
Overall Status: Active - Not Recruiting

Phase

3

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 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: 11
Treatment Group(s): 4
Primary Treatment: Cisplatin
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

    Site Not Available

  • Calvary Mater Newcastle

    Waratah, New South Wales 2298
    Australia

    Site Not Available

  • Royal North Shore Hospital

    St Leonards 8029783, New South Wales 2155400 2065
    Australia

    Site Not Available

  • Calvary Mater Newcastle

    Waratah 10103871, New South Wales 2155400 2298
    Australia

    Site Not Available

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • Peter Maccallum Cancer Centre

    Melbourne 2158177, Victoria 2145234 3000
    Australia

    Site Not Available

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Sir Charles Gairdner Hospital

    Nedlands 2064874, Western Australia 2058645 6009
    Australia

    Site Not Available

  • Universidade de Caxias do Sul - Rio Grande do Sul

    Caxias do Sul, Rio Grande Do Sul 95070-560
    Brazil

    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
    Brazil

    Site Not Available

  • Universidade de Caxias do Sul - Rio Grande do Sul

    Caxias do Sul 3466537, Rio Grande do Sul 3451133 95070-560
    Brazil

    Site Not Available

  • 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 90035-903
    Brazil

    Site Not Available

  • Hospital de Cancer de Barretos

    Barretos, São Paulo 14784-400
    Brazil

    Site Not Available

  • Hospital de Base de Sao Jose do Rio Preto

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

    Site Not Available

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    Sao Paulo, São Paulo 01246-000
    Brazil

    Site Not Available

  • Hospital de Cancer de Barretos

    Barretos 3470451, São Paulo 3448433 14784-400
    Brazil

    Site Not Available

  • Hospital de Base de Sao Jose do Rio Preto

    São José do Rio Preto 3448639, São Paulo 3448433 15090-000
    Brazil

    Site Not Available

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo 3448439, São Paulo 3448433 01246-000
    Brazil

    Site Not Available

  • K2 Oncology

    Providencia, 7500000
    Chile

    Site Not Available

  • K2 Oncology

    Providencia 3875139, 7500000
    Chile

    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

  • OrlandiOncología

    Santiago, 7500713
    Chile

    Site Not Available

  • RedSalud Vitacura

    Santiago,
    Chile

    Site Not Available

  • RedSalud Vitacura

    Santiago 3871336,
    Chile

    Site Not Available

  • James Lind Centro de Investigación Del Cáncer

    Temuco, 4800827
    Chile

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, 100142
    China

    Site Not Available

  • Beijing Cancer Hospital

    Beijing 1816670, 100142
    China

    Site Not Available

  • Xiangya Hospital of Centre-South University

    Changsha, 410008
    China

    Site Not Available

  • Xiangya Hospital of Centre-South University

    Changsha 1815577, 410008
    China

    Site Not Available

  • The third people's hospital of Chengdu

    Chengdu,
    China

    Site Not Available

  • The third people's hospital of Chengdu

    Chengdu 1815286,
    China

    Site Not Available

  • Guangdong General Hospital

    Guangzhou, 510000
    China

    Site Not Available

  • Guangdong General Hospital

    Guangzhou 1809858, 510000
    China

    Site Not Available

  • Jinhua municipal central hospital

    Jinhua,
    China

    Site Not Available

  • Jinhua municipal central hospital

    Jinhua 1805528,
    China

    Site Not Available

  • Yunnan Cancer Hospital

    Kunming, 650118
    China

    Site Not Available

  • Yunnan Cancer Hospital

    Kunming 1804651, 650118
    China

    Site Not Available

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

    Wuhan 1791247, 430030
    China

    Site Not Available

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

    Wuhan City, 430030
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Zhejiang, 310022
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Zhejiang 9898779, 310022
    China

    Site Not Available

  • Centre Leon Berard

    Lyon 2996944, 69008
    France

    Site Not Available

  • CHU Timone

    Marseille 2995469, 13005
    France

    Site Not Available

  • CHU de Bordeaux

    Pessac 2987805, 33600
    France

    Site Not Available

  • CHU Strasbourg - Nouvel Hopital Civil

    Strasbourg, 67091
    France

    Site Not Available

  • CHU Strasbourg - Nouvel Hopital Civil

    Strasbourg 2973783, 67091
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif 2968705, 94805
    France

    Site Not Available

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

    Meldola, Emilia-Romagna 47014
    Italy

    Site Not Available

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

    Meldola 3173635, Emilia-Romagna 3177401 47014
    Italy

    Site Not Available

  • Policlinico Universitario "Agostino Gemelli"

    Roma, Lazio 00168
    Italy

    Site Not Available

  • Policlinico Universitario "Agostino Gemelli"

    Rome 3169070, Lazio 3174976 00168
    Italy

    Site Not Available

  • Humanitas Gavazzeni

    Bergamo, Lombardia 24121
    Italy

    Site Not Available

  • Asst Grande Ospedale Metropolitano Niguarda

    Milano, Lombardia 20162
    Italy

    Site Not Available

  • Irccs Istituto Europeo di Oncologia (IEO)

    Milano, Lombardia 20141
    Italy

    Active - Recruiting

  • Humanitas Gavazzeni

    Bergamo 3182164, Lombardy 3174618 24121
    Italy

    Site Not Available

  • Asst Grande Ospedale Metropolitano Niguarda

    Milan 3173435, Lombardy 3174618 20162
    Italy

    Site Not Available

  • 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

  • Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia

    Perugia 3171180, Umbria 3165048 06156
    Italy

    Site Not Available

  • IRCCS Istituto Oncologico Veneto (IOV)

    Padova, Veneto 35128
    Italy

    Site Not Available

  • IRCCS Istituto Oncologico Veneto (IOV)

    Padua 3171728, Veneto 3164604 35128
    Italy

    Site Not Available

  • St. Vincent's Hospital

    Gyeonggi-do, 16247
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Centro Oncologico Internacional

    Mexico City 3530597, Mexico CITY (federal District) 04700
    Mexico

    Site Not Available

  • Centro Oncologico Internacional

    Mexico D.F., Mexico CITY (federal District) 04700
    Mexico

    Site Not Available

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

    Ciudad de México, 06700
    Mexico

    Site Not Available

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

    Mexico City 3530597, 06700
    Mexico

    Site Not Available

  • Auckland City Hospital, Cancer and Blood Research

    Auckland 2193733, 1023
    New Zealand

    Site Not Available

  • Centrum Pulmonologii i Torakochirurgii

    Bystra 3101987, 43-360
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-214
    Poland

    Site Not Available

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

    Poznan, 60-569
    Poland

    Site Not Available

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

    Poznan 3088171, 60-569
    Poland

    Site Not Available

  • Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad

    Warsaw 756135, 02-781
    Poland

    Site Not Available

  • Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad

    Warszawa, 02-781
    Poland

    Site Not Available

  • St. Vincent's Hospital

    Gyeonggi-do 6363696, 16247
    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

  • Severance Hospital, Yonsei University Health System

    Seoul 1835848, 03722
    South Korea

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid 3117735, 28041
    Spain

    Site Not Available

  • Hospital Regional Universitario Carlos Haya

    Malaga, 29010
    Spain

    Site Not Available

  • Hospital Regional Universitario Carlos Haya

    Málaga 2514256, 29010
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valencia

    Valencia 2509954, 46010
    Spain

    Site Not Available

  • Faculty of Med. Siriraj Hosp.

    Bangkok, 10700
    Thailand

    Site Not Available

  • Faculty of Med. Siriraj Hosp.

    Bangkok 1609350, 10700
    Thailand

    Site Not Available

  • Maharaj Nakorn Chiang Mai Hosp

    Chang Mai, 50200
    Thailand

    Site Not Available

  • Oncology Unit, Faculty of Medicine, Vajira Hospital

    Dusit, 10300
    Thailand

    Site Not Available

  • Oncology Unit, Faculty of Medicine, Vajira Hospital

    Dusit 1610858, 10300
    Thailand

    Site Not Available

  • Srinagarind Hospital

    Khon Kaen, 40002
    Thailand

    Site Not Available

  • Srinagarind Hospital

    Khon Kaen 1609776, 40002
    Thailand

    Site Not Available

  • University of Colorado Anschutz Medical Campus

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Clinical Research Alliance

    Westbury, New York 11590
    United States

    Site Not Available

  • Clinical Research Alliance

    Westbury 5144040, New York 5128638 11590
    United States

    Site Not Available

  • Baptist Cancer Center

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Baptist Cancer Center

    Memphis 4641239, Tennessee 4662168 38120
    United States

    Site Not Available

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