Clinical Trial: NCT04026412 - My Cancer Genome

NCT04026412

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)

Related Conditions:

Non-Small Cell Lung Carcinoma

Recruiting Status:

Recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT04026412

Trial Eligibility

Document

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

Trial Arms

Name	Type	Description	Interventions
Arm A: nivolumab + CCRT + ipilimumab	Experimental	Concurrent chemoradiotherapy (CCRT)	nivolumab ipilimumab
Arm B: nivolumab + CCRT	Experimental	Concurrent chemoradiotherapy (CCRT)	nivolumab
Arm C: CCRT + durvalumab	Experimental	Concurrent chemoradiotherapy (CCRT)	durvalumab

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

Clinical Trials /

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