Phase 3
N=925
A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery
Non-Small Cell Lung Cancer (NSCLC)
Bottom Line
View on ClinicalTrials.gov: NCT04026412 ↗Enrolled (actual)
925
Serious AEs
55.2%
Results posted
Jul 2025
Primary outcome: Primary: Arm A Vs Arm C - Progression-Free Survival (PFS) by RECIST 1.1 Per Blinded Independent Central Review (BICR) — 16.69; 15.64 months — p=0.6460
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- nivolumab (Biological); ipilimumab (Biological); durvalumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Arm A Vs Arm C - Progression-Free Survival (PFS) by RECIST 1.1 Per Blinded Independent Central Review (BICR) |
16.69; 15.64 | 0.6460 |
| SECONDARY Overall Survival (OS) |
34.60; 39.49; 39.79 | — |
| SECONDARY Arm B Vs Arm C and Arm A Vs Arm B- Progression-Free Survival (Irrespective of Subsequent Therapy) by RECIST 1.1 Per Blinded Independent Central Review (BICR) |
16.82; 17.38; 15.67 | — |
| SECONDARY Objective Response Rate (ORR) by BICR |
67.6; 72.2; 64.5 | — |
| SECONDARY Duration of Response (DoR) by RECIST 1.1 Per BICR |
25.76; 31.84; 25.17 | — |
| SECONDARY Time to Response (TTR) by RECIST 1.1 Per BICR |
2.92; 2.96; 2.92 | — |
| SECONDARY Progression Free Survival (PFS) by RECIST 1.1 Per Investigator Assessment |
16.82; 17.71; 16.53 | — |
| SECONDARY Objective Response Rate (ORR) by RECIST 1.1 Per Investigator Assessment |
61.3; 63.1; 57.9 | — |
| SECONDARY Duration of Response (DOR) by RECIST 1.1 Per Investigator Assessment |
22.83; 33.18; 27.93 | — |
| SECONDARY Time to Response (TTR) by RECIST 1.1 Per Investigator Assessment |
2.96; 2.92; 2.89 | — |
| SECONDARY Time to Death or Distant Metastases (TDDM) |
30.65; 36.14; 30.36 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Serious AEs and Select AEs |
279; 315; 312; 155; 156; 136 | — |
| SECONDARY Change From Baseline in Non-small Cell Lung Cancer (NSCLC)-Symptom Assessment Questionnaire (SAQ) Total Score at Week 48 |
-0.60; -0.91; -0.89 | — |
Summary
The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab vs CCRT followed by durvalumab in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC).
Eligibility Criteria
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0) pathologically-confirmed NSCLC, according to 8th TNM classification. Participants who are not planned for potential curative surgical resection are eligible.
- Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease
Exclusion Criteria
- Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the participant from adhering to the protocol or would increase the risk associated with study participation
- Active infection requiring systemic therapy within 14 days prior to randomization
- History of organ or tissue transplant that requires systemic use of immune suppressive agents
- Prior thoracic radiotherapy
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT04026412). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.