An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer (FRACTION-Lung)

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: Advanced Cancer

Treatments: Biological: Ipilimumab; Drug: BMS-986205; Drug: Dasatinib; Biological: Relatlimab; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02750514

CA018-001

Details and patient eligibility

About

The purpose of this study is to determine whether Nivolumab, in combination with other therapies, is effective in patients with advanced Non-Small Cell lung cancer

Enrollment: 295 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Advanced Non Small Cell Lung Cancer (NSCLC)
• Eastern Cooperative Oncology Group (ECOG) Performance status of ≤ 1
• Life expectancy of at least 3 months from most recent chemotherapy or immunotherapy treatment
• Must have at least 1 lesion with measurable disease

Exclusion Criteria:

• Subjects with certain mutations that have not been treated with a targeted therapy prior to enrollment
• Subjects who need daily oxygen therapy
• People with autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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295 participants in 5 patient groups

Nivolumab

Active Comparator group

Description:

Nivolumab Monotherapy - Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator

Treatment:

Biological: Nivolumab

Nivolumab & Dasatinib

Experimental group

Description:

Nivolumab in combination with Dasatinib

Treatment:

Biological: Nivolumab

Drug: Dasatinib

Nivolumab & Relatlimab

Experimental group

Description:

Nivolumab in combination with Relatlimab

Treatment:

Biological: Nivolumab

Biological: Relatlimab

Nivolumab & Ipilimumab

Experimental group

Description:

Nivolumab in combination with Ipilimumab

Treatment:

Biological: Nivolumab

Biological: Ipilimumab

Nivolumab & BMS-986205

Experimental group

Description:

Nivolumab in combination with BMS- 986205

Treatment:

Biological: Nivolumab

Drug: BMS-986205