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

NCT03091491 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2022-06-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Ipilimumab

Ipilimumab 1 mg/kg administered every 6 weeks as a 30 min IV infusion

DRUG

Nivolumab

Nivolumab 3 mg/kg administered every 2 weeks as a 30 min IV infusion

Sponsors & Collaborators

  • National University Hospital, Singapore

    collaborator OTHER

  • Johns Hopkins Singapore

    collaborator UNKNOWN

  • National Cancer Centre, Singapore

    lead OTHER

Principal Investigators

  • Eng Huat Tan · National Cancer Centre, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-07
Primary Completion
2019-11-18
Completion
2019-11-18

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03091491 on ClinicalTrials.gov