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NCT06946797Active, not recruitingPhase 2

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)

A Phase 2, Open-label, Randomized Trial to Evaluate Two Dosing Regimens of Subcutaneous Formulation of Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Previously Untreated Metastatic or Recurrent NSCLC

Source: ClinicalTrials.gov · Last updated 14 May 2026

Brief summary (registry, in English)

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)

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
76 (estimated)
First submitted
25 Apr 2025
Start date
19 Sept 2025
Primary completion date
5 Feb 2027
Lead sponsor
Bristol-Myers Squibb
Diseases
Lung cancer
NCT number
NCT06946797

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 76
  • From 19 Sept 2025 to the primary completion date, 5 Feb 2027
  • 38 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 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.

Other illness

  • 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 any history of interstitial lung disease or pneumonitis that required oral or IV glucocorticoids to assist with management.

Lab values

  • 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).

Other

  • Participants must not have any untreated central nervous system (CNS) metastases
  • Participants must not have leptomeningeal metastases (carcinomatous meningitis).
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (38)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
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BarretosBrazilUnknown status
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Belo HorizonteBrazilUnknown status
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BrasíliaBrazilUnknown status
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Porto AlegreBrazilUnknown status
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São PauloBrazilUnknown status
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SantiagoChileUnknown status
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DijonFranceUnknown status
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ParisFranceUnknown status
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SuresnesFranceUnknown status
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AthensGreeceUnknown status
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ChaïdáriGreeceUnknown status
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LarissaGreeceUnknown status
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ThessalonikiGreeceUnknown status
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BergamoItalyUnknown status
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FlorenceItalyUnknown status
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MeldolaItalyUnknown status
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NovaraItalyUnknown status
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UdineItalyUnknown status
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LodzPolandUnknown status
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PrabutyPolandUnknown status
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WarsawPolandUnknown status
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BucharestRomaniaUnknown status
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BucharestRomaniaUnknown status
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Cluj-NapocaRomaniaUnknown status
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CraiovaRomaniaUnknown status
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FloreștiRomaniaUnknown status
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IașiRomaniaUnknown status
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AllentownUnited StatesUnknown status
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AnchorageUnited StatesUnknown status
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BoiseUnited StatesUnknown status
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BoiseUnited StatesUnknown status
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ClevelandUnited StatesUnknown status
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ClevelandUnited StatesUnknown status
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Los AngelesUnited StatesUnknown status
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Post FallsUnited StatesUnknown status
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RondeboschSouth AfricaUnknown status
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SandtonSouth AfricaUnknown status
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SowetoSouth AfricaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.