Dr. Frances Shepherd
INCLUSION CRITERIA:
- Participant must be ≥ 18 years at the time of screening.
- Histologically- or cytologically-documented NSCLC and have been treated with
concurrent CRT for locally advanced, unresectable (Stage III) disease
- Provision of a tumour tissue sample obtained prior to CRT
- Documented tumour PD-L1 status by central lab
- Documented EGFR and ALK wild-type status (local or central).
- Patients must not have progressed following definitive, platinum based, concurrent
chemoradiotherapy
- Participants must have received at least 2 cycles of platinum-based chemotherapy
concurrent with radiation therapy
- Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66
Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy
should be administered by intensity modulated RT (preferred) or 3D-conforming
technique.
- WHO performance status of 0 or 1 at randomization
- Adequate organ and marrow function
EXCLUSION CRITERIA:
- History of another primary malignancy except for malignancy treated with curative
intent with no known active disease ≥5 years before the first dose of study
intervention and of low potential risk for recurrence, adequately resected
non-melanoma skin cancer and curatively treated in situ disease, or adequately
treated carcinoma in situ or Ta tumours without evidence of disease.
- Mixed small cell and non-small cell lung cancer histology.
- Participants who receive sequential (not inclusive of induction) chemoradiation
therapy for locally advanced (Stage III) unresectable NSCLC.
- Participants with locally advanced (Stage III) unresectable NSCLC who have
progressed during platinum-based cCRT.
- Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy
(excluding alopecia).
- Participants with ≥grade 2 pneumonitis from prior chemoradiation therapy.
- History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic
pneumonitis - regardless of time of onset prior to randomisation. Evidence of active
non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or
recently treated pleural effusion, or current pulmonary fibrosis - diagnosed in the
past 6 months prior to randomization.
- Active or prior documented autoimmune or inflammatory disorders (with exceptions)
- Current or prior use of immunosuppressive medication within 14 days before the first
dose of durvalumab.