A Dose Frequency Optimization, Phase IIIB/IV 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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 363
- Locations
- 245
- Primary Endpoint
- Progression Free Survival Rate (PFSR) at 6 Months
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Progression Free Survival Rate (PFSR) at 6 Months
Time Frame: At 6 Months
The proportion of participants remaining progression free and surviving at 6 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression.
Progression Free Survival Rate (PFSR) at 12 Months
Time Frame: At 12 Months
The proportion of participants remaining progression free and surviving at 6 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression.
Secondary Outcomes
- Overall Survival (OS) Rate at 12 Months(At 12 Months)
- Overall Survival (OS) Rate up to 60 Months(From randomization to the date of death, Up to 60 Months)
- Overall Survival Rate by Response Criteria at 12 Months(12 Months)
- Percentage of Participants With an Adverse Events (AEs)(Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months))
- Percentage of Participants With an Adverse Events Leading to Discontinuation (AEsDC)(Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months))
- Percentage of Participants Who Experienced Death(Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months))
- Progression Free Survival Rate (PFSR) at 24 Months(At 24 Months)
- Progression Free Survival Rate (PFSR) by Tumor Histology at 12 Months(At 12 Months)
- Percentage of Participants With an Immune Mediated Adverse Events (IMAEs)(Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months))
- Percentage of Participants With an Event of Special Interest (ESI)(Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months))
- Overall Survival Rate by Histology at 12 Months(at 12 Months)
- Percentage of Participants With an Serious Adverse Events (SAEs)(Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months))
- Progression Free Survival Rate (PFSR) by Response Criteria at 12 Months(At 12 Months)
- Percentage of Participants With an Select Adverse Events(Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months))
- Number of Participants With Laboratory Test Abnormalities(Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months))