Description:
The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent
chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab (Arm A) vs CCRT followed by
durvalumab (Arm C) in participants with untreated Locally Advanced Non-small Cell Lung Cancer
(LA NSCLC)
Title
- Brief Title: A Study of Nivolumab and Ipilimumab in Untreated Patients With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery
- Official Title: A Phase 3, Randomized, Open Label Study to Compare Nivolumab Plus Concurrent Chemoradiotherapy (CCRT) Followed by Nivolumab Plus Ipilimumab or Nivolumab Plus CCRT Followed by Nivolumab vs CCRT Followed by Durvalumab in Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)
Clinical Trial IDs
- ORG STUDY ID:
CA209-73L
- SECONDARY ID:
2019-001222-98
- NCT ID:
NCT04026412
Conditions
- Non-Small Cell Lung Cancer (NSCLC)
Interventions
Drug | Synonyms | Arms |
---|
nivolumab | | Arm A: nivolumab + CCRT + ipilimumab |
ipilimumab | | Arm A: nivolumab + CCRT + ipilimumab |
durvalumab | | Arm C: CCRT + durvalumab |
Purpose
The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent
chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab (Arm A) vs CCRT followed by
durvalumab (Arm C) in participants with untreated Locally Advanced Non-small Cell Lung Cancer
(LA NSCLC)
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A: nivolumab + CCRT + ipilimumab | Experimental | Concurrent chemoradiotherapy (CCRT) | |
Arm B: nivolumab + CCRT | Experimental | Concurrent chemoradiotherapy (CCRT) | |
Arm C: CCRT + durvalumab | Experimental | Concurrent chemoradiotherapy (CCRT) | |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
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)
histologically-confirmed NSCLC, according to 8th TNM classification
- 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 patient 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A and Arm C |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm B and Arm C |
Time Frame: | Up to 40 months |
Safety Issue: | |
Description: | |
Measure: | Overall Survival (OS) for Arm B and Arm C |
Time Frame: | Up to 55 months |
Safety Issue: | |
Description: | |
Measure: | Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A and Arm B |
Time Frame: | Up to 40 months |
Safety Issue: | |
Description: | |
Measure: | Overall Survival (OS) for Arm A and Arm B |
Time Frame: | Up to 55 months |
Safety Issue: | |
Description: | |
Measure: | Objective Response Rate (ORR) by RECIST 1.1 per Blinded Independent Central Review (BICR) |
Time Frame: | Up to 7.5 years |
Safety Issue: | |
Description: | |
Measure: | Complete Response Rate (CR rate) by RECIST 1.1 per Blinded Independent Central Review (BICR) |
Time Frame: | Up to 7.5 years |
Safety Issue: | |
Description: | |
Measure: | Duration of Response (DoR) by RECIST 1.1 per Blinded Independent Central Review (BICR) |
Time Frame: | Up to 7.5 years |
Safety Issue: | |
Description: | |
Measure: | Time to Response (TTR) by RECIST 1.1 per Blinded Independent Central Review (BICR) |
Time Frame: | Up to 7.5 years |
Safety Issue: | |
Description: | |
Measure: | Progression-free survival (PFS) by RECIST 1.1 per investigator assessment |
Time Frame: | Up to 40 months |
Safety Issue: | |
Description: | |
Measure: | Objective response rate (ORR) by RECIST 1.1 per investigator assessment |
Time Frame: | Up to 7.5 years |
Safety Issue: | |
Description: | |
Measure: | CR rate by RECIST 1.1 per investigator assessment |
Time Frame: | Up to 7.5 years |
Safety Issue: | |
Description: | |
Measure: | DoR by RECIST 1.1 per investigator assessment |
Time Frame: | Up to 7.5 years |
Safety Issue: | |
Description: | |
Measure: | TTR by RECIST 1.1 per investigator assessment |
Time Frame: | Up to 7.5 years |
Safety Issue: | |
Description: | |
Measure: | Time to death or distant metastases (TTDM) by RECIST 1.1 per Investigator assessment |
Time Frame: | Up to 7.5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of adverse events (AEs) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of serious adverse events (SAEs) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Proportion of participants without symptom deterioration based on LCS subscale of FACT-L and NSCLC-SAQ |
Time Frame: | 48 Weeks |
Safety Issue: | |
Description: | Lung Cancer Subscale (LCS), Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L), Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ) |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
July 26, 2021