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A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

NCT02352948 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 597

Last updated 2024-07-26

Study results available
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Summary

This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 (durvalumab) versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of MEDI4736 (durvalumab) plus tremelimumab (MEDI4736+treme) versus Standard of Care in NSCLC patients with PD-L1-negative tumours in the treatment of male and female patients with locally advanced or metastatic NSCLC (Stage IIIB-IV), who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC. Patients with known EGFR (Epidermal growth factor receptor) tyrosine kinase (TK) activating mutations and anaplastic lymphoma kinase (ALK) rearrangements are not eligible for the study (prospective testing is not planned within this study). The Standard of Care options are: an EGFR tyrosine kinase inhibitor (erlotinib \[TARCEVA®\]), gemcitabine or vinorelbine (NAVELBINE®)

Conditions

  • Non - Small Cell Lung Cancer NSCLC

Interventions

DRUG

MEDI4736 (durvalumab)

MEDI4736 (durvalumab) treatment by intravenous infusion

DRUG

Vinorelbine

Vinorelbine by intravenous infusion. Administered at a dose of 30 mg/m2 iv on Days 1, 8, 15 and 22 of a 28-day cycle.

DRUG

Gemcitabine

Gemcitabine by intravenous infusion. Administered at a dose of 1000 mg/m2 iv over 30 minutes on Days 1, 8, and 15 of a 28-day cycle.

DRUG

Erlotinib

Erlotinib administered at a dose of 150 mg once daily as a tablet for oral administration

DRUG

MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4)

MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4) treatment by intravenous infusion

DRUG

tremelimumab (anti-CTLA4)

tremelimumab (anti-CTLA4) treatment by intravenous infusion

Sponsors & Collaborators

Principal Investigators

  • Paul Stockman, MBChB, PhD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-13
Primary Completion
2018-02-09
Completion
2023-08-30

Countries

  • United States
  • Australia
  • Belgium
  • Bulgaria
  • Canada
  • Chile
  • Czechia
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Romania
  • Russia
  • Serbia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

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 NCT02352948 on ClinicalTrials.gov