Groupe d'Etude en Oncologie du Quebec

Title	A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab Following Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Unresected Stage I/II, Lymph-node Negative Non-small Cell Lung Cancer
Protocole ID	PACIFIC-4/RTOG-351
ClinicalTrials.gov ID	NCT03833154
Cancer Type(s)	Non Small Cells - Lung
Phase	Phase III
Stage
Study Type	Treatment
Drug	Radiothérapie stéréotaxique suivi de Durvalumab vs placebo
Institution	CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
City	Montréal
Principal Investigator	Dr. Thi Trinh Thuc Vu
Coordinator	Diane Trudel 514-890-8000 poste 11181
Status	Recruiting
Activation Date
Eligibility Criteria	Age ≥18 years Histologically or cytologically documented Stage I to II NSCLC, with clinical Stage I/II lymph node-negative (T1 to T3N0M0) disease and planned to receive definitive treatment with SBRT. Patients may be medically inoperable or are medically operable and refusing surgery or choosing to have SBRT (Stereotactic Body Radiation Therapy) as definitive therapy Completion of SoC SBRT as definitive treatment prior to randomization World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) PS of 0, 1, or 2 Life expectancy of at least 12 weeks Body weight >30 kg Tumor sample required Adequate organ and marrow function required Patients with central or peripheral lesions are eligible Staging studies must be done within 8 weeks before randomization
Exclusion Criteria	Mixed small cell and non-small cell cancer histology History of allogeneic organ transplantation History of another primary malignancy with exceptions History of active primary immunodeficiency Any unresolved toxicity National Cancer Institute (NCI) CTCAE Grade ≥2 from SBRT (Stereotactic Body Radiation Therapy)

Groupe d'étude en oncologie du Québec