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)

Running, not enrolling · Phase 3

Conditions studied: Non-Small-Cell Lung Carcinoma NSCLC

In brief

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

Key facts

Study ID

NCT02453282

Run by

AstraZeneca

People needed

1118

Starts

2015-07-21

Expected to finish

2026-12-31

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• Patients should not enter the study if any of the following exclusion criteria are fulfilled:
• Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant
• Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
• 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
• Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease]

Where it is running

• Research Site — Tucson, Arizona, United States
• Research Site — Yuma, Arizona, United States
• Research Site — Bakersfield, California, United States
• Research Site — Fullerton, California, United States
• Research Site — La Jolla, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Redondo Beach, California, United States
• Research Site — Sacramento, California, United States
• Research Site — San Luis Obispo, California, United States
• Research Site — Santa Maria, California, United States
• Research Site — West Hollywood, California, United States
• Research Site — New Haven, Connecticut, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Pembroke Pines, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Athens, Georgia, United States
• Research Site — Honolulu, Hawaii, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Omaha, Nebraska, United States
• Research Site — Summit, New Jersey, United States
• Research Site — Mineola, New York, United States
• Research Site — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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