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A Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
A Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

NCT02087423

CompletedPhase 2

Sponsor: AstraZeneca

Conditions: Non-Small Cell Lung Cancer

Interventions: MEDI4736

Countries: United States, Austria, Belgium, Canada, Czechia, France, Germany, Hungary

A study to assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in terms of efficacy, safety and tolerability

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Aged at least 18 years.
* Documented evidence of NSCLC (stage IIIB/IV disease)
* Disease progression or recurrence after both a platinum-based chemotherapy and at least 1 additional regimen for treatment of NSCLC
* World Health Organisation (WHO) Performance Status of 0 or 1
* Estimated life expectancy of more than 12 weeks
* Patient's tumour sample must be PD-L1 positive (≥25%of tumour cells with membrane staining (Cohort 1 and 2) or PD-L1 positive with ≥90% of tumour cells with membrane staining (Cohort 3))

Exclusion Criteria:

* Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
* Brain metastases or spinal cord compression or unless asymptomatic, treated and stable (not requiring steroids).
* Active or prior autoimmune disease or history of immunodeficiency
* Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
* Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris.
* Any unresolved toxicity CTCAE \>Grade 2 from previous anti-cancer therapy.
* Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE \>Grade 1
* Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)
Locations (139)
  • Goodyear, Arizona, United States
  • Santa Rosa, California, United States
  • New Haven, Connecticut, United States
  • Port Saint Lucie, Florida, United States
  • Tampa, Florida, United States
  • Lawrenceville, Georgia, United States
  • Waterloo, Iowa, United States
  • Topeka, Kansas, United States
  • Bethesda, Maryland, United States
  • Burlington, Massachusetts, United States
  • Worcester, Massachusetts, United States
  • Saint Louis Park, Minnesota, United States
  • New York, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • The Bronx, New York, United States
  • Huntersville, North Carolina, United States
  • Bismarck, North Dakota, United States
  • Fargo, North Dakota, United States
  • Blue Ash, Ohio, United States
  • Canton, Ohio, United States
  • Middletown, Ohio, United States
  • Chattanooga, Tennessee, United States
  • Nashville, Tennessee, United States
  • Fort Worth, Texas, United States
  • Spokane, Washington, United States
  • Wenatchee, Washington, United States
  • Vienna, Austria
  • Brussels, Belgium
  • + 109 more on CT.gov