A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC

A Phase 3, I44 Randomized Study of Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs Chemotherapy Alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223887

Enrollment

700

Registered

2018-04-24

Start date

2018-04-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC

Interventions

investigational material(s) Generic name etc : Nivolumab, Ipilimumab, Carboplatin, Paclitaxel, Pemetrexed, Cisplatin INN of investigational material : Nivolumab,Ipilimumab,Carboplatin,Paclitaxel,Peme

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy Eastern Cooperative Oncology Group (ECOG) Performance Status of less than 1 Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria Participants must have PD-L1 IHC testing with results performed by a central laboratory during the screening period

Exclusion criteria

Exclusion criteria: Participants with known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution mutations) are excluded Participants with known anaplastic lymphoma kinase (ALK) translocations which are sensitive to available targeted inhibitor therapy are excluded Participants with untreated CNS metastases are excluded. Participants are eligible if CNS metastases are adequately treated and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first treatment

Design outcomes

Primary

Measure	Time frame
efficacy 1.Overall Survival (OS) [ Time Frame: Up to 25 months ] To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy versus (vs)chemotherapy	—

Secondary

Measure	Time frame
efficacy Progression Free Survival (PFS) [ Time Frame: Up to 25 months ] Overall Response Rate (ORR) [ Time Frame: Up to 25 months ] OS [ Time Frame: Up to 25 months ] [PFS_ORR] -To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy vs chemotherapy -In participants with different PD-L1 levels -In association with tumor cell total somatic mutation numbers [OS] -In participants with different PD-L1 levels -In association with tumor cell total somatic mutation numbers	—

Measure

Time frame

efficacy Progression Free Survival (PFS) [ Time Frame: Up to 25 months ] Overall Response Rate (ORR) [ Time Frame: Up to 25 months ] OS [ Time Frame: Up to 25 months ] [PFS_ORR] -To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy vs chemotherapy -In participants with different PD-L1 levels -In association with tumor cell total somatic mutation numbers [OS] -In participants with different PD-L1 levels -In association with tumor cell total somatic mutation numbers

—

Countries

Argentina, Australia, Belgium, Brazil, Canada, Chile, China, France, Germany, Ireland, Italy, Mexico, Poland, Romania, Russian Federation, Spain, United Kingdom, United States

Contacts

Public ContactAoyama Takekazu

Bristol-Myers Squibb K.K.

MG-JP-RCO-JRCT@bms.com+81-120-093-507

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026