Summary

for people ages 18-130 (full criteria)
at UCLA
study started
estimated completion:

Description

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

Official Title

A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC) (MYSTIC)

Details

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.

Keywords

Non-Small-Cell Lung Carcinoma NSCLC NSCLC, PD-L1, MEDI4736, Tremelimumab, PFS, OS Carcinoma, Non-Small-Cell Lung Lung Neoplasms Gemcitabine Tremelimumab Cisplatin Carboplatin Pemetrexed Antineoplastic Agents Antibodies, Monoclonal MEDI4736 (Durvalumab) MEDI4736 (Durvalumab)+Tremelimumab Paclitaxel + Carboplatin Gemcitabine + Cisplatin Gemcitabine + Carboplatin Pemetrexed + Cisplatin Pemetrexed + Carboplatin Monotherapy

Eligibility

You can join if…

Open to people ages 18-130

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

You CAN'T join if...

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

  • Research Site
    Los Angeles California 90095 United States
  • Research Site
    Los Angeles California 90073 United States
  • Research Site
    La Jolla California 92093 United States
  • Research Site
    Los Angeles California 90048 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT02453282
Phase
Phase 3
Study Type
Interventional
Last Updated