A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received Up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks (CheckMate 384)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Lung Cancer

Treatments: Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02713867

CA209-384

Details and patient eligibility

About

The primary objective of this study is to compare PFS (progression-free survival) rate at 6 months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks with nivolumab 240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC (non-Sq and Sq).

Enrollment: 363 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:

• Histologically or cytologically documented Squamous or non-Squamous Non-small cell lung cancer (NSCLC) (Stage IIIB/IV), or recurrent or progressive disease following multimodal therapy
• Patients must have received pre-study nivolumab for up to 12 months and have 2 consecutive tumor assessments confirming Complete response (CR), Partial response (PR), or Stable disease (SD)
• Measurable disease before start of pre-study nivolumab treatment
• Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2

Exclusion Criteria:

• Carcinomatous meningitis
• Untreated, symptomatic Central nervous system (CNS) metastases
• Symptomatic interstitial lung 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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363 participants in 2 patient groups

Nivolumab 240 mg

Active Comparator group

Description:

Nivolumab 240 mg Every 2 Weeks

Treatment:

Biological: Nivolumab

Nivolumab 480 mg

Experimental group

Description:

Nivolumab 480 mg Every 4 Weeks

Treatment:

Biological: Nivolumab