Active Not RecruitingPhase 3NCT02453282

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)

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

Checked against the public recordLast updated Aug 6, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 3
U.S. locations196
SponsorAstraZeneca
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
AstraZeneca
Interventions being studied
Biological: MEDI4736 (Durvalumab); Biological: MEDI4736 (Durvalumab)+Tremelimumab; Drug: Paclitaxel + Carboplatin; Drug: Gemcitabine + Cisplatin; Drug: Gemcitabine + Carboplatin; Drug: Pemetrexed + Cisplatin; Drug: Pemetrexed + Carboplatin; Biological: Tremelimumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: For inclusion in the study, patients should fulfill the following criteria: * Aged at least 18 years * Documented evidence of Stage IV NSCLC * No sensitizing EGFR mutation or ALK rearrangement * No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC * World Health Organization (WHO) Performance Status of 0 or 1 Exclusion Criteria: Patients should not enter the study if any of the following exclusion criteria are fulfilled: 1. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant 2. Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids) 3. Prior exposure to Immunomodulatory therapy (IMT), including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies, excluding therapeutic anticancer vaccines 4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\]

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Research SiteScottsdale, Arizona
  • Research SiteTucson, Arizona
  • Research SiteYuma, Arizona
  • Research SiteBakersfield, California
  • Research SiteFullerton, California
  • Research SiteLa Jolla, California
  • Research SiteLos Angeles, California
  • Research SiteLos Angeles, California
  • Research SiteRedondo Beach, California
  • Research SiteSacramento, California
  • Research SiteSan Luis Obispo, California
  • Research SiteSanta Maria, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 6, 2026. Always confirm current availability with the study team.

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