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: July 25, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - 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:
August 02, 2025
Estimated Completion Date:
October 25, 2028

Connect with a study center

  • Local Institution - 0041

    Brasilia, Distrito Federal 70200-730
    Brazil

    Site Not Available

  • Local Institution - 0043

    Belo Horizonte, Minas Gerais 30380-490
    Brazil

    Site Not Available

  • Local Institution - 0038

    Porto Alegre, Rio Grande Do Sul 90035-903
    Brazil

    Site Not Available

  • Local Institution - 0037

    Barretos, São Paulo 14784400
    Brazil

    Site Not Available

  • Local Institution - 0034

    São Paulo, 01246-000
    Brazil

    Site Not Available

  • Local Institution - 0068

    Antofagasta, AN 1240000
    Chile

    Site Not Available

  • Local Institution - 0067

    Santiago, Región Metropolitana De Santiago 8420383
    Chile

    Site Not Available

  • Local Institution - 0069

    Viña del Mar, Valparaíso 2520598
    Chile

    Site Not Available

  • Local Institution - 0065

    Dijon, Côte-d'Or 21079
    France

    Site Not Available

  • Local Institution - 0003

    Suresnes, Hauts-de-Seine 92151
    France

    Site Not Available

  • Local Institution - 0010

    Paris, Île-de-France 75014
    France

    Site Not Available

  • Local Institution - 0012

    Athens, Attikí 115 27
    Greece

    Site Not Available

  • Local Institution - 0013

    Chaidari, Attikí 12462
    Greece

    Site Not Available

  • Local Institution - 0011

    Thessaloniki, Kentrikí Makedonía 540 07
    Greece

    Site Not Available

  • Local Institution - 0014

    Larissa, Thessalía 41110
    Greece

    Site Not Available

  • Local Institution - 0015

    Meldola, Emilia-Romagna 47014
    Italy

    Site Not Available

  • Local Institution - 0057

    Udine, Friuli-Venezia Giulia 33100
    Italy

    Site Not Available

  • Local Institution - 0020

    Bergamo, Lombardia 24127
    Italy

    Site Not Available

  • Local Institution - 0019

    Firenze, Toscana 50134
    Italy

    Site Not Available

  • Local Institution - 0017

    Novara, 28100
    Italy

    Site Not Available

  • Local Institution - 0025

    Guadalajara, Jalisco 44630
    Mexico

    Site Not Available

  • Local Institution - 0058

    Monterrey, Nuevo León 64460
    Mexico

    Site Not Available

  • Local Institution - 0027

    Merida, Yucatán 97070
    Mexico

    Site Not Available

  • Local Institution - 0024

    Mexico, 06700
    Mexico

    Site Not Available

  • Local Institution - 0022

    Puebla, 72424
    Mexico

    Site Not Available

  • Local Institution - 0081

    Warszawa, Mazowieckie 03-411
    Poland

    Site Not Available

  • Local Institution - 0080

    Prabuty, Pomorskie 82-550
    Poland

    Site Not Available

  • Local Institution - 0079

    Łódź, Łódzkie 93-338
    Poland

    Site Not Available

  • Local Institution - 0073

    Bucharest, București 022328
    Romania

    Site Not Available

  • Local Institution - 0076

    Florești, Cluj 407280
    Romania

    Site Not Available

  • Local Institution - 0077

    Craiova, Dolj 200542
    Romania

    Site Not Available

  • Local Institution - 0075

    Bucharest, 020335
    Romania

    Site Not Available

  • Local Institution - 0074

    Cluj, 400015
    Romania

    Site Not Available

  • Local Institution - 0078

    Iași, 700483
    Romania

    Site Not Available

  • Local Institution - 0009

    Sandton, 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

  • Local Institution - 0084

    Rondebosch, Western Cape 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

  • Alaska Oncology and Hematology

    Anchorage, Alaska 99508
    United States

    Active - Recruiting

  • Local Institution - 0032

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Local Institution - 0062

    Los Angeles, California 90033
    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

  • Local Institution - 0064

    Post Falls, Idaho 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

  • Local Institution - 0051

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

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