A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease Has Remained Stable or Responded to First-Line Platinum -Based Chemotherapy With Pembrolizumab for Stage IIIB/IIIC or IV Non-Small Cell Lung Cancer (ZEAL-1L)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease Has Remained Stable or Responded to First-Line Platinum -Based Chemotherapy With Pembrolizumab for Stage IIIB/IIIC or IV Non-Small Cell Lung Cancer (ZEAL-1L)
This is a multicenter, randomized, double-blind, placebo-controlled study of niraparib plus pembrolizumab versus placebo plus pembrolizumab as maintenance therapy in participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have achieved stable disease (SD), partial response (PR), or complete response (CR) following completion of standard of care first-line (SoC 1L) platinum-based induction chemotherapy with pembrolizumab. The primary hypotheses are: participants with confirmed diagnosis of NSCLC could benefit from niraparib plus pembrolizumab versus placebo plus pembrolizumab with respect to Progression-free survival (PFS) and Overall survival (OS).
Inclusion criteria:
Exclusion criteria:
Cipoletti Rio Negro, R8324CVE, Argentina
Ciudad Autonoma de Buenos Aire, C1012AAR, Argentina
Ciudad Autonoma de Buenos Aire, C1426AGE, Argentina
Heraklion Crete, 71110, Greece
Pylaia Thessaloniki, 57001, Greece
Rio Patras, 26500, Greece
Aviano PN, 33081, Italy
Orbassano to, 10043, Italy
Puebla Puebla, 72560, Mexico
Lrenskog, 1470, Norway
Seongnam-si Gyeonggi-do, 13620, South Korea
Suwon Kyunggi-do, 443-721, South Korea
Las Palmas de Gran Canar, 35016, Spain
PamplonaNavarra, 31008, Spain