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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)

NCT ID: NCT06946797

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-19

Study Completion Date

2028-10-25

Brief Summary

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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)

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Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Ipilimumab

Intervention Type DRUG

Specified dose on specified days

Carboplatin

Intervention Type DRUG

Specified dose on specified days

Paclitaxel

Intervention Type DRUG

Specified dose on specified days

Pemetrexed

Intervention Type DRUG

Specified dose on specified days

Cisplatin

Intervention Type DRUG

Specified dose on specified days

Arm B

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Ipilimumab

Intervention Type DRUG

Specified dose on specified days

Carboplatin

Intervention Type DRUG

Specified dose on specified days

Paclitaxel

Intervention Type DRUG

Specified dose on specified days

Pemetrexed

Intervention Type DRUG

Specified dose on specified days

Cisplatin

Intervention Type DRUG

Specified dose on specified days

Interventions

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Nivolumab

Specified dose on specified days

Intervention Type DRUG

Ipilimumab

Specified dose on specified days

Intervention Type DRUG

Carboplatin

Specified dose on specified days

Intervention Type DRUG

Paclitaxel

Specified dose on specified days

Intervention Type DRUG

Pemetrexed

Specified dose on specified days

Intervention Type DRUG

Cisplatin

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-986298 Yervoy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Alaska Oncology and Hematology

Anchorage, Alaska, United States

Site Status RECRUITING

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

Local Institution - 0088

Newport Beach, California, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0063

Boise, Idaho, United States

Site Status NOT_YET_RECRUITING

Saint Alphonsus Regional Medical Center

Boise, Idaho, United States

Site Status RECRUITING

Local Institution - 0064

Post Falls, Idaho, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0047

Cleveland, Ohio, United States

Site Status NOT_YET_RECRUITING

MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status RECRUITING

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

Site Status RECRUITING

Local Institution - 0041

Brasília, Federal District, Brazil

Site Status NOT_YET_RECRUITING

Local Institution - 0043

Belo Horizonte, Minas Gerais, Brazil

Site Status NOT_YET_RECRUITING

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo, Brazil

Site Status RECRUITING

Icesp - Instituto Do Câncer Do Estado de São Paulo

São Paulo, , Brazil

Site Status RECRUITING

Local Institution - 0068

Antofagasta, AN, Chile

Site Status NOT_YET_RECRUITING

Local Institution - 0069

Viña del Mar, Región de Valparaíso, Chile

Site Status NOT_YET_RECRUITING

Local Institution - 0067

Santiago, Santiago Metropolitan, Chile

Site Status NOT_YET_RECRUITING

Centre Georges François Leclerc

Dijon, Côte-d'Or, France

Site Status RECRUITING

Hôpital Foch

Suresnes, Hauts-de-Seine, France

Site Status RECRUITING

Groupe hospitalier Paris saint Joseph

Paris, Île-de-France Region, France

Site Status RECRUITING

Thoracic General Hospital of Athens "I Sotiria"

Athens, Attikí, Greece

Site Status RECRUITING

Local Institution - 0013

Chaïdári, Attikí, Greece

Site Status NOT_YET_RECRUITING

Local Institution - 0011

Thessaloniki, Kentrikí Makedonía, Greece

Site Status NOT_YET_RECRUITING

University General Hospital of Larissa

Larissa, Thessalía, Greece

Site Status RECRUITING

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

Meldola, Emilia-Romagna, Italy

Site Status RECRUITING

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

Udine, Friuli Venezia Giulia, Italy

Site Status RECRUITING

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Bergamo, Lombardy, Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, , Italy

Site Status RECRUITING

Local Institution - 0025

Guadalajara, Jalisco, Mexico

Site Status NOT_YET_RECRUITING

Local Institution - 0058

Monterrey, Nuevo León, Mexico

Site Status NOT_YET_RECRUITING

Local Institution - 0027

Mérida, Yucatán, Mexico

Site Status NOT_YET_RECRUITING

Local Institution - 0024

México, , Mexico

Site Status NOT_YET_RECRUITING

Local Institution - 0022

Puebla City, , Mexico

Site Status NOT_YET_RECRUITING

Local Institution - 0081

Warsaw, Masovian Voivodeship, Poland

Site Status NOT_YET_RECRUITING

Szpital Specjalistyczny w Prabutach Spolka z o.o.

Prabuty, Pomeranian Voivodeship, Poland

Site Status RECRUITING

Instytut Centrum Zdrowia Matki Polki

Lodz, Łódź Voivodeship, Poland

Site Status RECRUITING

Institutul Oncologic Bucuresti

Bucharest, București, Romania

Site Status RECRUITING

SC Radiotherapy Center Cluj SRL

Florești, Cluj, Romania

Site Status RECRUITING

Centrul de Oncologie "Sfântul Nectarie"

Craiova, Dolj, Romania

Site Status RECRUITING

Centrul de Diagnostic si Tratament Provita

Bucharest, , Romania

Site Status RECRUITING

Institutul Oncologic Cluj

Cluj-Napoca, , Romania

Site Status RECRUITING

Institutul Regional de Oncologie

Iași, , Romania

Site Status RECRUITING

Local Institution - 0066

Pretoria, Gauteng, South Africa

Site Status WITHDRAWN

Local Institution - 0031

Soweto, Gauteng, South Africa

Site Status NOT_YET_RECRUITING

Local Institution - 0009

Sandton, GP, South Africa

Site Status NOT_YET_RECRUITING

Cancercare Rondebosch Oncology

Rondebosch, Western Cape, South Africa

Site Status RECRUITING

Local Institution - 0070

Adana, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Local Institution - 0072

Ankara, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Local Institution - 0071

Istanbul, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Countries

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United States Brazil Chile France Greece Italy Mexico Poland Romania South Africa Turkey (Türkiye)

Central Contacts

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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Role: CONTACT

[email protected]
8559073286

First line of the email MUST contain the NCT# and Site#

Role: CONTACT

Facility Contacts

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Steven Liu, Site 0032

Role: primary

907-257-9851

Jorge Nieva, Site 0062

Role: primary

323-865-0421

Site 0088

Role: primary

Site 0063

Role: primary

Leila Khaddour, Site 0052

Role: primary

208-367-3131

Site 0064

Role: primary

Site 0047

Role: primary

Peter Xie, Site 0033

Role: primary

216-778-7328

Muhammad Rizvi, Site 0051

Role: primary

610-402-7880

Site 0041

Role: primary

Site 0043

Role: primary

Sergio De Azevedo, Site 0038

Role: primary

0000000000

Flavio Augusto Ferreria Da Silva, Site 0037

Role: primary

551733216637

Milena Perez Mak, Site 0034

Role: primary

551138932632

Site 0068

Role: primary

Site 0069

Role: primary

Site 0067

Role: primary

Coureche Kaderbhai, Site 0065

Role: primary

33380737504

Jaafar Bennouma, Site 0003

Role: primary

+33240679949

Charles Naltet, Site 0010

Role: primary

33144123752

Konstantinos Syrigos, Site 0012

Role: primary

+302107700220

Site 0013

Role: primary

Site 0011

Role: primary

Athanasios Kotsakis, Site 0014

Role: primary

302413502124

Angelo Delmonte, Site 0015

Role: primary

+393487469100

Marianna Macerelli, Site 0057

Role: primary

+390432554550

Anna Bettini, Site 0020

Role: primary

+390352673694

Lorenzo Antonuzzo, Site 0019

Role: primary

00390557947298

Gloria Borra, Site 0017

Role: primary

393213733989

Site 0025

Role: primary

Site 0058

Role: primary

Site 0027

Role: primary

Site 0024

Role: primary

Site 0022

Role: primary

Site 0081

Role: primary

Anna Lowczak, Site 0080

Role: primary

+48503022396

Ewa Kalinka, Site 0079

Role: primary

+48530770073

Aurelia Alexandru, Site 0073

Role: primary

40723289606

Andrei Ungureanu, Site 0076

Role: primary

40742206212

Michael Schenker, Site 0077

Role: primary

40727774974

Mircea Dediu, Site 0075

Role: primary

0040744432443

Tudor Ciuleanu, Site 0074

Role: primary

40745646368

Dana Clement, Site 0078

Role: primary

40744692062

Site 0031

Role: primary

Site 0009

Role: primary

Jean-Marc Maurel, Site 0084

Role: primary

27219443700

Site 0070

Role: primary

Site 0072

Role: primary

Site 0071

Role: primary

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06946797.html

BMS Clinical Trial Patient Recruiting

Other Identifiers

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CA209-1533

Identifier Type: -

Identifier Source: org_study_id

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