MK7339-008

Primary Objectives
-To compare pembrolizumab plus maintenance olaparib with pembrolizumab plus placebo with respect to progression-free survival (PFS) assessed according to RECIST 1.1 (Section 4.2.1.1) by blinded independent central review (BICR).
-To compare pembrolizumab plus maintenance olaparib with pembrolizumab plus placebo with respect to overall survival (OS).

Secondary Objectives
-To evaluate the safety and tolerability of pembrolizumab plus maintenance olaparib compared to pembrolizumab plus placebo.
-To evaluate the change from baseline (at randomization) and the time to true deterioration (TTD) in global health status/quality of life (QoL), cough, chest pain, dyspnea and physical functioning following
treatment with pembrolizumab plus maintenance olaparib compared to
pembrolizumab plus placebo. This clinical trial will study the combination of pembrolizumab and the polyadenosine 5′
diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor, olaparib, in the
treatment of squamous non-small cell lung cancer (NSCLC).
Phase d’induction
Tous les patients recevront 4 cycles (Q3sem) de Pembrolizumab 200mg IV (jour 1), Carboplatine IV AUC = 6mg/ML/min IV (jour1), Paclitaxel IV 200mg/m2 (jour 1) ou Nab-paclitaxel IV 100mg/m2 (jour 1, 8, 15).

Phase de maintien (31 cycles)
Participants avec une réponse partielle ou complète à la maladie ou avec une maladie stable qui répondent aux critères d’éligibilité après le quatrième cycle de la phase d’induction :

Groupe A : Pembrolizumab 200mg IV Q3sem jour 1, Olaparib 300mg PO BID tous les jours

Groupe B : Pembrolizumab 200mg IV Q3sem jour 1, Placebo PO BID tous les jours