Study on MEDI4736 for Patients with Completely Removed Non-Small Cell Lung Cancer

Sponsor: Canadian Cancer Trials Group

Sponsor score: 0

ClinicalTrials ID:NCT02273375

This clinical trial is testing whether a new drug, MEDI4736, is more effective than no further treatment after surgery for non-small cell lung cancer (NSCLC).

Patient Parameters

Program Overview

The aim of this study is to determine if taking the new drug MEDI4736 after surgery (and possibly chemotherapy) is better than not receiving any additional treatment for patients with non-small cell lung cancer (NSCLC).

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with primary non-small cell lung cancer (NSCLC), excluding large-cell neuroendocrine carcinomas.
  • Classified as Stage IB (tumor size ≥ 4cm), II, or IIIA after surgery.
  • Complete surgical removal of the lung cancer, with no remaining visible disease.
  • No prior chemotherapy before surgery, but post-surgery chemotherapy is allowed.
  • No previous cancer treatments other than standard post-surgery chemotherapy.
  • Patients with N2 disease who had post-surgery radiation are eligible if they meet timing criteria.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Meet specific blood and organ function criteria.
  • Willing and able to complete quality of life and other questionnaires.
  • Must provide informed consent and be available for treatment and follow-up.
  • Treatment to start within 2 days of being assigned to a group.

Exclusion Criteria

  • History of other cancers, except for certain skin cancers or cancers treated with no recurrence for 5 years.
  • Combination of small cell and non-small cell lung cancer, or certain other lung tumors.
  • History of autoimmune diseases, except for controlled Grave's disease or psoriasis, and stable hypothyroidism.
  • History of immune system deficiencies or organ transplants requiring immunosuppression.
  • Recent live vaccines or severe reactions to immune therapies.
  • Heart conditions that are untreated or uncontrolled.
  • Current use of other investigational drugs or cancer therapies.
  • Active infections or serious medical conditions that prevent following the study protocol.
  • Pregnant or breastfeeding women, or those not using effective contraception.

Locations

FACILITYZIPCITYSTATE
Banner MD Anderson Cancer Center85234GilbertArizona
USC Norris/Comprehensive Cancer Centre9003308Los AngelesCalifornia
National Jewish Health80206DenverColorado
University of Florida32610-0277GainesvilleFlorida
H. Lee Moffitt Cancer Center33612TampaFlorida
Duke University Medical Center27710DurhamNorth Carolina
Hematology and Oncology Associates of NEPA18512DunmorePennsylvania
Thomas Jefferson University19107PhiladelphiaPennsylvania
The Reading Hospital Medical Center19611West ReadingPennsylvania

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