Study of Nivolumab Verses Nivolumab and Ipilimumab Combination in EGFR Mutant Non-small Cell Lung Cancer

Sponsor
National Cancer Centre, Singapore
Study ID
NCT03091491
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — DRUG
    Ipilimumab 1 mg/kg administered every 6 weeks as a 30 min IV infusion
  • Nivolumab — DRUG
    Nivolumab 3 mg/kg administered every 2 weeks as a 30 min IV infusion

Study Details

The purpose of this study is to determine whether Nivolumab in combination with Ipilimumab is associated with superior response rate compared to Nivolumab alone in patients with advanced Epidermal Growth Factor Receptor (EGFR) mutation positive Non-small Cell Lung Cancer who have failed one line of standard EGFR tyrosine kinase inhibitor and not more than one line of chemotherapy regimen. This study also aims to determine predictive biomarkers of response/benefit in patients with EGFR mutation positive NSCLC.

Key Dates

Start date
Apr 7, 2017
Status verified
Jun 2022
Primary completion
Nov 18, 2019
Completion
Nov 18, 2019

Study Design

Enrollment
31 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
  • Experimental: Nivolumab and Ipilimumab

Primary Outcome Measure

Overall Response Rate [ Time Frame: From baseline until best overall response of Complete Response (CR) or Partial Response (PR), up to 2 years ]

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