Brief Summary
This is a Phase III, randomised, double-blind, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advancedat a late stage, far along (Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.
Intervention / Treatment
- Drug: Durvalumab
- Drug: Oleclumab
- Drug: Monalizumab
- Other: Placebo
Inclusion Criteria
- Participant must be ≥ 18 years at the time of screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening.
- Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
- Provision of a tumoura tissue mass that forms from groups of unhealthy cells tissuea group of cells that work together to perform a function 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 chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells concurrent with radiation therapya treatment that uses controlled doses of radiation to damage or kill cancer cells
- Participants must have received a total dosethe amount of medication taken 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.