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New Shot-Based immunotherapy combo tested for lung cancer

NCT ID NCT06946797

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests two different schedules of a subcutaneous (under-the-skin) form of the immunotherapy drug nivolumab, given together with intravenous ipilimumab and chemotherapy. It includes 76 adults with advanced or recurrent non-small cell lung cancer who have not had prior treatment for their advanced disease. The main goal is to measure drug levels in the blood and check safety.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 76 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

Contacts and locations

Locations

  • Local Institution - 0003

    Suresnes, Hauts-de-Seine, 92151, France

  • Local Institution - 0009

    Sandton, GP, 2196, South Africa

  • Local Institution - 0010

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

  • Local Institution - 0011

    Thessaloniki, Kentrikí Makedonía, 540 07, Greece

  • Local Institution - 0012

    Athens, Attikí, 115 27, Greece

  • Local Institution - 0013

    Chaïdári, Attikí, 12462, Greece

  • Local Institution - 0014

    Larissa, Thessalía, 41110, Greece

  • Local Institution - 0015

    Meldola, Emilia-Romagna, 47014, Italy

  • Local Institution - 0017

    Novara, 28100, Italy

  • Local Institution - 0019

    Florence, Tuscany, 50134, Italy

  • Local Institution - 0020

    Bergamo, Lombardy, 24127, Italy

  • Local Institution - 0031

    Soweto, Gauteng, 2013, South Africa

  • Local Institution - 0032

    Anchorage, Alaska, 99508, United States

  • Local Institution - 0033

    Cleveland, Ohio, 44109, United States

  • Local Institution - 0034

    São Paulo, 01246-000, Brazil

  • Local Institution - 0037

    Barretos, São Paulo, 14784400, Brazil

  • Local Institution - 0038

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

  • Local Institution - 0041

    Brasília, Federal District, 70200-730, Brazil

  • Local Institution - 0043

    Belo Horizonte, Minas Gerais, 30380-490, Brazil

  • Local Institution - 0047

    Cleveland, Ohio, 44106, United States

  • Local Institution - 0051

    Allentown, Pennsylvania, 18103, United States

  • Local Institution - 0052

    Boise, Idaho, 83706, United States

  • Local Institution - 0057

    Udine, Friuli Venezia Giulia, 33100, Italy

  • Local Institution - 0062

    Los Angeles, California, 90033, United States

  • Local Institution - 0063

    Boise, Idaho, 83702, United States

  • Local Institution - 0064

    Post Falls, Idaho, 83854, United States

  • Local Institution - 0065

    Dijon, Côte-d'Or, 21079, France

  • Local Institution - 0067

    Santiago, Santiago Metropolitan, 8420383, Chile

  • Local Institution - 0073

    Bucharest, Bucharest, 022328, Romania

  • Local Institution - 0074

    Cluj-Napoca, 400015, Romania

  • Local Institution - 0075

    Bucharest, 020335, Romania

  • Local Institution - 0076

    Florești, Cluj, 407280, Romania

  • Local Institution - 0077

    Craiova, Dolj, 200542, Romania

  • Local Institution - 0078

    Iași, 700483, Romania

  • Local Institution - 0079

    Lodz, Łódź Voivodeship, 93-338, Poland

  • Local Institution - 0080

    Prabuty, Pomeranian Voivodeship, 82-550, Poland

  • Local Institution - 0081

    Warsaw, Masovian Voivodeship, 03-411, Poland

  • Local Institution - 0084

    Rondebosch, Western Cape, 7700, South Africa

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