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Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC)

NCT02453282 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1118

Last updated 2026-05-12

Study results available
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Summary

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced or metastatic NSCLC

Conditions

  • Non-Small-Cell Lung Carcinoma NSCLC

Interventions

BIOLOGICAL

MEDI4736 (Durvalumab)

BIOLOGICAL

MEDI4736 (Durvalumab)+Tremelimumab

DRUG

Paclitaxel + Carboplatin

Chemotherapy Agents

DRUG

Gemcitabine + Cisplatin

Chemotherapy Agents

DRUG

Gemcitabine + Carboplatin

Chemotherapy Agents

DRUG

Pemetrexed + Cisplatin

Chemotherapy Agents

DRUG

Pemetrexed + Carboplatin

Chemotherapy Agents

BIOLOGICAL

Tremelimumab

Sponsors & Collaborators

Principal Investigators

  • Stuart McIntosh, MD · AstraZeneca, Alderley Park, Cheshire, UK

  • Naiyer Rizvi, MD · Columbia University Medical Center, New York, NY, USA

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
2015-07-21
Primary Completion
2018-10-04
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Hungary
  • Italy
  • Japan
  • Netherlands
  • Russia
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • Vietnam

Study Locations

More Related Trials

Entities

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 NCT02453282 on ClinicalTrials.gov