For Healthcare Professionals

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)

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About the study

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
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

For inclusion in the study, patients should fulfill the following criteria:

  1. Aged at least 18 years
  2. Documented evidence of Stage IV NSCLC
  3. No sensitizing EGFR mutation or ALK rearrangement
  4. No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC
  5. 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]
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-877-240-9479Email iconEmail Study Center

Study’s details


Contition

Non-Small-Cell Lung Carcinoma (NSCLC),Non-Small-Cell Lung Carcinoma NSCLC

Age (in years)

18 - 130

Phase

Phase 3

Participants needed

1118

Est. Completion Date

Jun 2023

Treatment type

Interventional


Sponsor

AstraZeneca

ClinicalTrials.gov identifier

NCT02453282

Study number

D419AC00001

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