Canadian Cancer Trials Group 2014

Trial name or title	A phase III prospective double blind placebo controlled randomized study of adjuvant MEDI4736 in completely resected non‐small cell lung cancer
Methods	Interventional RCT, Phrase III
Participants	Number of participants: 1100 (October 2014 to January 2025 ) Number randomised: Experimental group (MEDI47361 immunotherapy): not specified Control group (Placebo): not specified Number evaluated: Experimental group: not specified Control group: not specified Diagnosis: patients with locally advanced unresectable stage III NSCLC Inclusion: The eligibility criteria are as follows: ≥ 18 years of age; Histologically confirmed diagnosis of primary non‐small cell carcinoma of the lung. Patients must be classified post‐operatively as Stage IB (≥ 4 cm in the longest diameter), II or IIIA on the basis of pathologic criteria. Complete surgical resection of the primary NSCLC is also mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumour. Resection may be accomplished by open or VATS techniques
Interventions	Experimental group: MEDI4736 by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier. Control group: PLACEBO by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier.
Outcomes	This trial is currently recruiting participants. Disease Free Survival, overall survival, adverse events
Starting date	October 22, 2014
Contact information	Correspondence for published protocol: cocallaghan@ctg.queensu.ca
Notes	Patient recruiting stage