NCT06946797
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)
Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatmentBristol-Myers Squibb
~76 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:NivolumabIpilimumabCarboplatinPaclitaxelPemetrexedCisplatin
At a glance
Recruiting sites
0 of 38 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum observed serum concentration (Cmax) of subcutaneous Nivolumab in serum
Measured over Up to 3 weeks
+4 more outcomes measured
Conditions
Where it's being run
38 sites across 32 statesIdaho3
Romania3
Ohio2
Attikí2
Alaska1
California1
Pennsylvania1
Federal District1
Study leadership
- Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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.
What this trial measures
- Maximum observed serum concentration (Cmax) of subcutaneous Nivolumab in serumUp to 3 weeks
- Time to peak concentration (Tmax) of subcutaneous Nivolumab in serumUp to 3 weeks
- Area under the concentration-time curve within a dosing interval (AUC(TAU)) of subcutaneous Nivolumab in serumUp to 3 weeks
- Concentration at the end of a dosing interval (Ctau) of subcutaneous Nivolumab in serumUp to 3 weeks
- Trough observed concentration (Ctrough) of subcutaneous NivolumabAt Cycle 7 Day 1 (Week 18)