A Study to Evaluate Two Dosing Regimens of Subcutaneous Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Previously Untreated Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Last updated: May 13, 2026
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Not Recruiting

Phase

2

Condition

Non-small Cell Lung Cancer

Treatment

Pemetrexed

Paclitaxel

Ipilimumab

Clinical Study ID

NCT06946797
CA209-1533
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate two dosing regimens of subcutaneous Nivolumab in combination with intravenous Ipilimumab and chemotherapy in participants with previously untreated metastatic or recurrent Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Participants must have histologically confirmed stage IV or recurrent non-small cell lung cancer (NSCLC) (as defined by the 9th edition of the IASLC Lung Cancer Staging Guidelines) of squamous or non-squamous histology.

  • Participants must have no prior systemic anti-cancer treatment (including EGFR, ALK, ROS-1, BRAF, RET, and NTRK inhibitors) given as primary therapy for advanced or metastatic disease.

  • Participants with prior definitive chemoradiation for locally advanced disease is permitted as long as the last administration of chemotherapy or radiotherapy (whichever was given last) occurred at least 6 months prior to randomization. Participants with locally advanced disease with recurrence after chemoradiation therapy (stage III disease, specifically refers to patients with no curative options) are eligible to enroll.

  • Participants with prior adjuvant or neoadjuvant chemotherapy for early-stage lung cancer are permitted if completed at least 6 months prior to randomization.

  • Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 at screening and confirmed prior to randomization.

  • Participants must have measurable disease by CT or MRI per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria with radiographic tumor assessment performed within 28 days of randomization.

Exclusion Criteria

  • Participants must not have any prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.

  • Participants must not have any known driver mutations with available targeted therapy (including but not limited to EGFR mutations, ALK translocations, ROS-1 translocations and known BRAFV600E, that are sensitive to available targeted inhibitor therapy; participants with a known activating RET mutations and NTRK fusion gene alterations).

  • Participants must not have any untreated central nervous system (CNS) metastases

  • Participants must not have leptomeningeal metastases (carcinomatous meningitis).

  • Participants must not have any active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.

  • Participants with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to randomization and no additional therapy is required or anticipated to be required during the study period.

  • Participants must not have a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.

  • Participants must not have any history of interstitial lung disease or pneumonitis that required oral or IV glucocorticoids to assist with management.

  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Total Participants: 76
Treatment Group(s): 6
Primary Treatment: Pemetrexed
Phase: 2
Study Start date:
September 19, 2025
Estimated Completion Date:
October 25, 2028

Connect with a study center

  • Local Institution - 0041

    Brasilia, Distrito Federal 70200-730
    Brazil

    Site Not Available

  • Hospital Sirio Libanes

    Brasília, Federal District 70200-730
    Brazil

    Active - Recruiting

  • Local Institution - 0041

    Brasília, Federal District 70200-730
    Brazil

    Site Not Available

  • Local Institution - 0041

    Brasília 3469058, Federal District 3463504 70200-730
    Brazil

    Site Not Available

  • Hospital Luxemburgo

    Belo Horizonte, Minas Gerais 30380-490
    Brazil

    Active - Recruiting

  • Local Institution - 0043

    Belo Horizonte, Minas Gerais 30380-490
    Brazil

    Site Not Available

  • Local Institution - 0043

    Belo Horizonte 3470127, Minas Gerais 3457153 30380-490
    Brazil

    Site Not Available

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul 90035-903
    Brazil

    Active - Recruiting

  • Local Institution - 0038

    Porto Alegre, Rio Grande do Sul 90035-903
    Brazil

    Site Not Available

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre 3452925, Rio Grande do Sul 3451133 90035-903
    Brazil

    Site Not Available

  • Local Institution - 0038

    Porto Alegre 3452925, Rio Grande do Sul 3451133 90035-903
    Brazil

    Site Not Available

  • Fundação Pio XII - Hospital de Câncer de Barretos

    Barretos, São Paulo 14784400
    Brazil

    Active - Recruiting

  • Local Institution - 0037

    Barretos, São Paulo 14784400
    Brazil

    Site Not Available

  • Fundação Pio XII - Hospital de Câncer de Barretos

    Barretos 3470451, São Paulo 3448433 14784400
    Brazil

    Site Not Available

  • Local Institution - 0037

    Barretos 3470451, São Paulo 3448433 14784400
    Brazil

    Site Not Available

  • Icesp - Instituto Do Câncer Do Estado de São Paulo

    São Paulo, 01246-000
    Brazil

    Active - Recruiting

  • Local Institution - 0034

    São Paulo, 01246-000
    Brazil

    Site Not Available

  • Icesp - Instituto Do Câncer Do Estado de São Paulo

    São Paulo 3448439, 01246-000
    Brazil

    Site Not Available

  • Local Institution - 0034

    São Paulo 3448439, 01246-000
    Brazil

    Site Not Available

  • Local Institution - 0068

    Antofagasta, AN 1240000
    Chile

    Site Not Available

  • Local Institution - 0068

    Antofagasta 3899539, AN 1240000
    Chile

    Site Not Available

  • Local Institution - 0069

    Viña del Mar, Región de Valparaíso 2520598
    Chile

    Site Not Available

  • Local Institution - 0069

    Viña del Mar 3868121, Región de Valparaíso 3868621 2520598
    Chile

    Site Not Available

  • Bradfordhill

    Santiago, Santiago Metropolitan 8420383
    Chile

    Active - Recruiting

  • Local Institution - 0067

    Santiago, Santiago Metropolitan 8420383
    Chile

    Site Not Available

  • Local Institution - 0067

    Santiago 3871336, Santiago Metropolitan 3873544 8420383
    Chile

    Site Not Available

  • Centre Georges François Leclerc

    Dijon, Côte-d'Or 21079
    France

    Active - Recruiting

  • Local Institution - 0065

    Dijon, Côte-d'Or 21079
    France

    Site Not Available

  • Centre Georges François Leclerc

    Dijon 3021372, Côte-d'Or 21079
    France

    Site Not Available

  • Local Institution - 0065

    Dijon 3021372, Côte-d'Or 21079
    France

    Site Not Available

  • Hôpital Foch

    Suresnes, Hauts-de-Seine 92151
    France

    Active - Recruiting

  • Local Institution - 0003

    Suresnes, Hauts-de-Seine 92151
    France

    Site Not Available

  • Hôpital Foch

    Suresnes 2973675, Hauts-de-Seine 92151
    France

    Site Not Available

  • Local Institution - 0003

    Suresnes 2973675, Hauts-de-Seine 92151
    France

    Site Not Available

  • Groupe hospitalier Paris saint Joseph

    Paris, Île-de-France Region 75014
    France

    Active - Recruiting

  • Local Institution - 0010

    Paris, Île-de-France Region 75014
    France

    Site Not Available

  • Groupe hospitalier Paris saint Joseph

    Paris 2988507, Île-de-France Region 3012874 75014
    France

    Site Not Available

  • Local Institution - 0010

    Paris 2988507, Île-de-France Region 3012874 75014
    France

    Site Not Available

  • Local Institution - 0012

    Athens, Attikí 115 27
    Greece

    Site Not Available

  • Thoracic General Hospital of Athens "I Sotiria"

    Athens, Attikí 115 27
    Greece

    Active - Recruiting

  • Local Institution - 0012

    Athens 264371, Attikí 115 27
    Greece

    Site Not Available

  • Thoracic General Hospital of Athens "I Sotiria"

    Athens 264371, Attikí 115 27
    Greece

    Site Not Available

  • Local Institution - 0013

    Chaidari, Attikí 12462
    Greece

    Site Not Available

  • Local Institution - 0013

    Chaïdári, Attikí 12462
    Greece

    Site Not Available

  • University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"

    Chaïdári, Attikí 12462
    Greece

    Active - Recruiting

  • Local Institution - 0013

    Chaïdári 260183, Attikí 12462
    Greece

    Site Not Available

  • University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"

    Chaïdári 260183, Attikí 12462
    Greece

    Site Not Available

  • "Theagenio" Cancer Hospital of Thessaloniki

    Thessaloniki, Kentrikí Makedonía 540 07
    Greece

    Active - Recruiting

  • Local Institution - 0011

    Thessaloniki, Kentrikí Makedonía 540 07
    Greece

    Site Not Available

  • "Theagenio" Cancer Hospital of Thessaloniki

    Thessaloniki 734077, Kentrikí Makedonía 540 07
    Greece

    Site Not Available

  • Local Institution - 0011

    Thessaloniki 734077, Kentrikí Makedonía 540 07
    Greece

    Site Not Available

  • Local Institution - 0014

    Larissa, Thessalía 41110
    Greece

    Site Not Available

  • University General Hospital of Larissa

    Larissa, Thessalía 41110
    Greece

    Active - Recruiting

  • Local Institution - 0014

    Larissa 258576, Thessalía 41110
    Greece

    Site Not Available

  • University General Hospital of Larissa

    Larissa 258576, Thessalía 41110
    Greece

    Site Not Available

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

    Meldola, Emilia-Romagna 47014
    Italy

    Active - Recruiting

  • Local Institution - 0015

    Meldola, Emilia-Romagna 47014
    Italy

    Site Not Available

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

    Meldola 3173635, Emilia-Romagna 3177401 47014
    Italy

    Site Not Available

  • Local Institution - 0015

    Meldola 3173635, Emilia-Romagna 3177401 47014
    Italy

    Site Not Available

  • Local Institution - 0057

    Udine, Friuli Venezia Giulia 33100
    Italy

    Site Not Available

  • P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale

    Udine, Friuli Venezia Giulia 33100
    Italy

    Active - Recruiting

  • Local Institution - 0057

    Udine 3165072, Friuli Venezia Giulia 3176525 33100
    Italy

    Site Not Available

  • P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale

    Udine 3165072, Friuli Venezia Giulia 3176525 33100
    Italy

    Site Not Available

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    Bergamo, Lombardy 24127
    Italy

    Active - Recruiting

  • Local Institution - 0020

    Bergamo, Lombardy 24127
    Italy

    Site Not Available

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    Bergamo 3182164, Lombardy 3174618 24127
    Italy

    Site Not Available

  • Local Institution - 0020

    Bergamo 3182164, Lombardy 3174618 24127
    Italy

    Site Not Available

  • Local Institution - 0019

    Firenze, Toscana 50134
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Tuscany 50134
    Italy

    Active - Recruiting

  • Local Institution - 0019

    Florence, Tuscany 50134
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi

    Florence 3176959, Tuscany 3165361 50134
    Italy

    Site Not Available

  • Local Institution - 0019

    Florence 3176959, Tuscany 3165361 50134
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Maggiore della Carità

    Novara, 28100
    Italy

    Active - Recruiting

  • Local Institution - 0017

    Novara, 28100
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Maggiore della Carità

    Novara 3172189, 28100
    Italy

    Site Not Available

  • Local Institution - 0017

    Novara 3172189, 28100
    Italy

    Site Not Available

  • Local Institution - 0025

    Guadalajara, Jalisco 44630
    Mexico

    Site Not Available

  • Local Institution - 0025

    Guadalajara 4005539, Jalisco 4004156 44630
    Mexico

    Site Not Available

  • Local Institution - 0058

    Monterrey, Nuevo León 64460
    Mexico

    Site Not Available

  • Local Institution - 0058

    Monterrey 3995465, Nuevo León 3522542 64460
    Mexico

    Site Not Available

  • Local Institution - 0027

    Merida, Yucatán 97070
    Mexico

    Site Not Available

  • Local Institution - 0027

    Mérida, Yucatán 97070
    Mexico

    Site Not Available

  • Local Institution - 0027

    Mérida 3523349, Yucatán 3514211 97070
    Mexico

    Site Not Available

  • Local Institution - 0024

    Mexico, 06700
    Mexico

    Site Not Available

  • Local Institution - 0024

    México, 06700
    Mexico

    Site Not Available

  • Local Institution - 0024

    México 10248874, 06700
    Mexico

    Site Not Available

  • Local Institution - 0022

    Puebla, 72424
    Mexico

    Site Not Available

  • Local Institution - 0022

    Puebla City, 72424
    Mexico

    Site Not Available

  • Local Institution - 0022

    Puebla City 3521081, 72424
    Mexico

    Site Not Available

  • Local Institution - 0081

    Warsaw, Masovian Voivodeship 03-411
    Poland

    Site Not Available

  • Mazowiecki Szpital Onkologiczny

    Warsaw, Masovian Voivodeship 03-411
    Poland

    Active - Recruiting

  • Local Institution - 0081

    Warsaw 756135, Masovian Voivodeship 858787 03-411
    Poland

    Site Not Available

  • Mazowiecki Szpital Onkologiczny

    Warsaw 756135, Masovian Voivodeship 858787 03-411
    Poland

    Site Not Available

  • Local Institution - 0081

    Warszawa, Mazowieckie 03-411
    Poland

    Site Not Available

  • Local Institution - 0080

    Prabuty, Pomeranian Voivodeship 82-550
    Poland

    Site Not Available

  • Szpital Specjalistyczny w Prabutach Spolka z o.o.

    Prabuty, Pomeranian Voivodeship 82-550
    Poland

    Active - Recruiting

  • Local Institution - 0080

    Prabuty 3088161, Pomeranian Voivodeship 3337496 82-550
    Poland

    Site Not Available

  • Szpital Specjalistyczny w Prabutach Spolka z o.o.

    Prabuty 3088161, Pomeranian Voivodeship 3337496 82-550
    Poland

    Site Not Available

  • Local Institution - 0079

    Łódź, Łódzkie 93-338
    Poland

    Site Not Available

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, Łódź Voivodeship 93-338
    Poland

    Active - Recruiting

  • Local Institution - 0079

    Lodz, Łódź Voivodeship 93-338
    Poland

    Site Not Available

  • Instytut Centrum Zdrowia Matki Polki

    Lodz 3093133, Łódź Voivodeship 3337493 93-338
    Poland

    Site Not Available

  • Local Institution - 0079

    Lodz 3093133, Łódź Voivodeship 3337493 93-338
    Poland

    Site Not Available

  • Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu"

    Bucharest, Bucharest 022328
    Romania

    Active - Recruiting

  • Local Institution - 0073

    Bucharest, Bucharest 022328
    Romania

    Site Not Available

  • Institutul Oncologic Bucuresti

    Bucharest 683506, București 683504 022328
    Romania

    Site Not Available

  • Local Institution - 0073

    Bucharest 683506, București 683504 022328
    Romania

    Site Not Available

  • Local Institution - 0076

    Florești, Cluj 407280
    Romania

    Site Not Available

  • SC Radiotherapy Center Cluj SRL

    Florești, Cluj 407280
    Romania

    Active - Recruiting

  • Centrul de Oncologie "Sfântul Nectarie"

    Craiova, Dolj 200542
    Romania

    Active - Recruiting

  • Local Institution - 0077

    Craiova, Dolj 200542
    Romania

    Site Not Available

  • Centrul de Oncologie "Sfântul Nectarie"

    Craiova 680332, Dolj 679134 200542
    Romania

    Site Not Available

  • Local Institution - 0077

    Craiova 680332, Dolj 679134 200542
    Romania

    Site Not Available

  • Centrul de Diagnostic si Tratament Provita

    Bucharest, 020335
    Romania

    Active - Recruiting

  • Local Institution - 0075

    Bucharest, 020335
    Romania

    Site Not Available

  • Centrul de Diagnostic si Tratament Provita

    Bucharest 683506, 020335
    Romania

    Active - Recruiting

  • Local Institution - 0075

    Bucharest 683506, 020335
    Romania

    Site Not Available

  • Local Institution - 0074

    Cluj, 400015
    Romania

    Site Not Available

  • Institutul Oncologic Cluj

    Cluj-Napoca, 400015
    Romania

    Active - Recruiting

  • Local Institution - 0074

    Cluj-Napoca, 400015
    Romania

    Site Not Available

  • Institutul Oncologic Cluj

    Cluj-Napoca 681290, 400015
    Romania

    Site Not Available

  • Local Institution - 0074

    Cluj-Napoca 681290, 400015
    Romania

    Site Not Available

  • Institutul Regional de Oncologie

    Iași, 700483
    Romania

    Active - Recruiting

  • Local Institution - 0078

    Iași, 700483
    Romania

    Site Not Available

  • Institutul Regional de Oncologie

    Iași 675810, 700483
    Romania

    Site Not Available

  • Local Institution - 0078

    Iași 675810, 700483
    Romania

    Site Not Available

  • Local Institution - 0009

    Sandton, GP 2196
    South Africa

    Site Not Available

  • Local Institution - 0009

    Sandton 957654, GP 2196
    South Africa

    Site Not Available

  • Local Institution - 0066

    Pretoria, Gauteng 0181
    South Africa

    Site Not Available

  • Local Institution - 0031

    Soweto, Gauteng 2013
    South Africa

    Site Not Available

  • Wits Clinical Research

    Soweto, Gauteng 2013
    South Africa

    Active - Recruiting

  • Local Institution - 0066

    Pretoria 964137, Gauteng 1085594 0181
    South Africa

    Site Not Available

  • Local Institution - 0031

    Soweto 953781, Gauteng 1085594 2013
    South Africa

    Site Not Available

  • Wits Clinical Research

    Soweto 953781, Gauteng 1085594 2013
    South Africa

    Site Not Available

  • Cancercare Rondebosch Oncology

    Rondebosch, Western Cape 7700
    South Africa

    Active - Recruiting

  • Local Institution - 0084

    Rondebosch, Western Cape 7700
    South Africa

    Site Not Available

  • Cancercare Rondebosch Oncology

    Rondebosch 7302802, Western Cape 1085599 7700
    South Africa

    Site Not Available

  • Local Institution - 0084

    Rondebosch 7302802, Western Cape 1085599 7700
    South Africa

    Site Not Available

  • Local Institution - 0070

    Adana, 01140
    Turkey

    Site Not Available

  • Local Institution - 0072

    Ankara, 06010
    Turkey

    Site Not Available

  • Local Institution - 0071

    Istanbul, 34214
    Turkey

    Site Not Available

  • Local Institution - 0070

    Adana, 01140
    Turkey (Türkiye)

    Site Not Available

  • Local Institution - 0070

    Adana 325363, 01140
    Turkey (Türkiye)

    Site Not Available

  • Local Institution - 0072

    Ankara, 06010
    Turkey (Türkiye)

    Site Not Available

  • Local Institution - 0072

    Ankara 323786, 06010
    Turkey (Türkiye)

    Site Not Available

  • Local Institution - 0071

    Istanbul, 34214
    Turkey (Türkiye)

    Site Not Available

  • Local Institution - 0071

    Istanbul 745044, 34214
    Turkey (Türkiye)

    Site Not Available

  • Alaska Oncology and Hematology

    Anchorage, Alaska 99508
    United States

    Active - Recruiting

  • Local Institution - 0032

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Alaska Oncology and Hematology

    Anchorage 5879400, Alaska 5879092 99508
    United States

    Site Not Available

  • Local Institution - 0062

    Los Angeles, California 90033
    United States

    Site Not Available

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Local Institution - 0088

    Newport Beach, California 92663
    United States

    Site Not Available

  • Local Institution - 0062

    Los Angeles 5368361, California 5332921 90033
    United States

    Site Not Available

  • USC/Norris Comprehensive Cancer Center

    Los Angeles 5368361, California 5332921 90033
    United States

    Site Not Available

  • Local Institution - 0088

    Newport Beach 5376890, California 5332921 92663
    United States

    Site Not Available

  • Local Institution - 0052

    Boise, Idaho 83706
    United States

    Site Not Available

  • Local Institution - 0063

    Boise, Idaho 83702
    United States

    Site Not Available

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho 83706
    United States

    Active - Recruiting

  • Beacon Cancer Care

    Post Falls, Idaho 83854
    United States

    Active - Recruiting

  • Local Institution - 0064

    Post Falls, Idaho 83854
    United States

    Site Not Available

  • Local Institution - 0052

    Boise 5586437, Idaho 5596512 83706
    United States

    Site Not Available

  • Local Institution - 0063

    Boise 5586437, Idaho 5596512 83702
    United States

    Site Not Available

  • Saint Alphonsus Regional Medical Center

    Boise 5586437, Idaho 5596512 83706
    United States

    Site Not Available

  • Beacon Cancer Care

    Post Falls 5604353, Idaho 5596512 83854
    United States

    Site Not Available

  • Local Institution - 0064

    Post Falls 5604353, Idaho 5596512 83854
    United States

    Site Not Available

  • Local Institution - 0033

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • Local Institution - 0047

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • MetroHealth Medical Center

    Cleveland, Ohio 44109
    United States

    Active - Recruiting

  • Local Institution - 0033

    Cleveland 5150529, Ohio 5165418 44109
    United States

    Site Not Available

  • Local Institution - 0047

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Site Not Available

  • MetroHealth Medical Center

    Cleveland 5150529, Ohio 5165418 44109
    United States

    Site Not Available

  • Lehigh Valley Health Network

    Allentown, Pennsylvania 18103
    United States

    Active - Recruiting

  • Local Institution - 0051

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

  • Lehigh Valley Health Network

    Allentown 5178127, Pennsylvania 6254927 18103
    United States

    Site Not Available

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