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)

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT02453282

This Phase III study evaluates the efficacy and safety of MEDI4736 with or without tremelimumab versus platinum-based chemotherapy in first-line treatment of Stage IV NSCLC patients without EGFR/ALK mutations. Eligible participants are adults with WHO Performance Status 0-1 and no prior systemic therapy. Interventions include biological therapies and various chemotherapy regimens.

Patient Parameters

Program Overview

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

Description

Patients will be randomized in a 1:1:1 ratio to receive treatment with MEDI4736 + tremelimumab combination therapy, MEDI4736 monotherapy, or Standard of Care (SoC) therapy.

Eligibility Criteria

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]

Locations

FACILITYZIPCITYSTATE
Research Site85259ScottsdaleArizona
Research Site85715TucsonArizona
Research Site85364YumaArizona
Research Site93309BakersfieldCalifornia
Research Site92835FullertonCalifornia
Research Site92093La JollaCalifornia
Research Site90024Los AngelesCalifornia
Research Site90073Los AngelesCalifornia
Research Site90277Redondo BeachCalifornia
Research Site95817SacramentoCalifornia

Get This Program In Your Inbox

You can sign up and apply your patients for this program.