A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 in Completely Resected Non-Small Cell Lung Cancer (BR31)

You may be able to join if

• Histologically confirmed diagnosis of primary non-small cell carcinoma of the lung according to WHO Classification of Tumours (WHO Classification of Tumours of the Lung, Pleura, Thymus and Heart. WHO/IARC Classification of Tumours, 4th Edition, Volume 7). Patients with large-cell neuroendocrine carcinomas are not eligible.
• Patients must be classified post-operatively as Stage IB (≥ 4cm in the longest diameter), II or IIIA on the basis of pathologic criteria.
• Surgery: -A pre-surgical PET scan of the thorax and a MRI or CT scan of the brain is considered standard of care and thus must be done prior to surgery. Patients in whom this was not done prior to surgery may still be enrolled providing that appropriate imaging is performed prior to randomization. -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. -Lymph node mapping is defined by The International Association for the Study of Lung Cancer (IASLC) lymph node map. The nodal tissue should be labelled according to the recommendations of the American Thoracic Society. Surgeons are strongly encouraged to dissect or sample all accessible nodal levels in accordance with the European Society of Thoracic Surgeons guidelines. Accordingly, it is recommended that a minimum of 3 (three) lobe specific mediastinal nodal stations (N2), one of which should include station 7, and at least one N1 station - inclusive of the ones removed with the pulmonary specimen have been sampled at the end of the procedure. -If preoperative CT and/or PET are suspicious for mediastinal nodal involvement, it is recommended that invasive mediastinal staging with mediastinoscopy or EBUS-TBNA be performed. Station 5 or 6 lymph nodes may be accessed by anterior mediastinotomy or VATS. This may also occur at the time of the surgical resection. If invasive staging shows disease in regional lymph nodes, they must be surgically removed. It is recommended that complete mediastinal lymph node dissection be undertaken for stage IIIA tumours. -Surgery may consist of lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the intraoperative findings. Patients who have had only segmentectomies or wedge resections are not eligible for this study. Note: Where a resection has been extended by means of a wedge resection of an adjacent lobe in order to ensure complete resection of a tumour at or crossing a fissure between lobes, as long as the margins are clear this is acceptable. Where the resection of a second tumour nodule, even where not considered to be a co-primary, is undertaken by means of a wedge resection of a separate lobe then the patient is not eligible.