Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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)
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)

NCT02453282

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Non-Small-Cell Lung Carcinoma NSCLC

Interventions: MEDI4736 (Durvalumab), MEDI4736 (Durvalumab)+Tremelimumab, Paclitaxel + Carboplatin, Gemcitabine + Cisplatin, Gemcitabine + Carboplatin

Countries: United States, Australia, Belgium, Canada, France, Germany, Hungary, Italy

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

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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 (196)
  • Scottsdale, Arizona, United States
  • Tucson, Arizona, United States
  • Yuma, Arizona, United States
  • Bakersfield, California, United States
  • Fullerton, California, United States
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Redondo Beach, California, United States
  • Sacramento, California, United States
  • San Luis Obispo, California, United States
  • Santa Maria, California, United States
  • West Hollywood, California, United States
  • New Haven, Connecticut, United States
  • Jacksonville, Florida, United States
  • Pembroke Pines, Florida, United States
  • Tampa, Florida, United States
  • Athens, Georgia, United States
  • Honolulu, Hawaii, United States
  • Baltimore, Maryland, United States
  • Minneapolis, Minnesota, United States
  • St Louis, Missouri, United States
  • Omaha, Nebraska, United States
  • Summit, New Jersey, United States
  • Mineola, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Charlotte, North Carolina, United States
  • Cleveland, Ohio, United States
  • + 166 more on CT.gov