CompletedPhase 3NCT02352948

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

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®)

Checked against the public recordLast updated Jul 26, 2024 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 3
U.S. locations201
SponsorAstraZeneca
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Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
AstraZeneca
Interventions being studied
Drug: MEDI4736 (durvalumab); Drug: Vinorelbine; Drug: Gemcitabine; Drug: Erlotinib; Drug: MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4); Drug: tremelimumab (anti-CTLA4)
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: * Aged at least 18 years * Documented evidence of NSCLC (Stage IIIB/ IV disease) * Disease progression or recurrence after both a platinum-based chemotherapy regimen and at least 1 additional regimen for treatment of NSCLC * World Health Organization (WHO) Performance Status of 0 or 1 * Estimated life expectancy more than 12 weeks Exclusion Criteria: * Prior exposure to any anti-PD-1 or anti-PD-L1 antibody or anti-CTLA4 * Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids) * Active or prior documented autoimmune disease within the past 2 years * Evidence of severe or uncontrolled systemic disease, including active bleeding diatheses or active infections including hepatitis B, C and HIV * Any unresolved toxicity CTCAE (Common Terminology Criteria of Adverse Events) \>Grade 2 from previous anti-cancer therapy * Known EGFR TK activating mutations or ALK rearrangements * Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE \>Grade 1 * Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)

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 SiteChandler, Arizona
  • Research SiteAnaheim, California
  • Research SiteDuarte, California
  • Research SiteLa Jolla, California
  • Research SiteSan Diego, California
  • Research SiteAurora, Colorado
  • Research SiteFort Myers, Florida
  • Research SiteOrlando, Florida
  • Research SitePort Saint Lucie, Florida
  • Research SiteSt. Petersburg, Florida
  • Research SiteAthens, Georgia
  • Research SiteAtlanta, Georgia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 26, 2024. Always confirm current availability with the study team.

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