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Two dosing approaches of subcutaneous nivolumab with ipilimumab and chemotherapy for untreated metastatic or recurrent 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

PHASE2 · Bristol-Myers Squibb · NCT06946797

This study tests two ways of giving subcutaneous nivolumab together with IV ipilimumab and chemotherapy to see if the combination is safe and active for people with untreated metastatic or recurrent NSCLC.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment76 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb (industry)
Drugs / interventionschemotherapy, prednisone, Nivolumab, Ipilimumab
Locations48 sites (Anchorage, Alaska and 47 other locations)
Trial IDNCT06946797 on ClinicalTrials.gov

What this trial studies

This phase 2 trial compares two dosing regimens of subcutaneous nivolumab given alongside intravenous ipilimumab and standard platinum-based chemotherapy in participants with previously untreated stage IV or recurrent non-small cell lung cancer. Treatment includes subcutaneous nivolumab, IV ipilimumab, and chemotherapy agents such as carboplatin with paclitaxel or pemetrexed depending on tumor histology. Eligible participants must have no prior systemic therapy for advanced disease, with some allowances for prior adjuvant/neoadjuvant therapy or chemoradiation completed at least six months earlier. The study focuses on safety, tolerability, and early signals of anti-tumor activity to guide dosing choices for future development.

Who should consider this trial

Good fit: Adults with histologically confirmed stage IV or recurrent NSCLC (squamous or non-squamous) who have not received prior systemic therapy for advanced disease and who meet the timing rules for any prior adjuvant or definitive chemoradiation are ideal candidates.

Not a fit: Patients who have already received systemic therapy for metastatic NSCLC or who have contraindications to immunotherapy or platinum-based chemotherapy are unlikely to benefit from this first-line combination in the trial.

Why it matters

Potential benefit: If successful, a subcutaneous nivolumab option could make immunotherapy easier to receive with fewer clinic resources while maintaining clinical benefit.

How similar studies have performed: Nivolumab plus ipilimumab combinations have shown activity in NSCLC in previous studies, but using a subcutaneous formulation of nivolumab is a newer approach with more limited clinical data.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Anchorage, Alaska and 47 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Non-Small Cell Lung Cancer, Nivolumab, Ipilimumab, Checkmate-1533, CA2091533, NSCLC

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.