RKHO_TESARO_3000-02-001

Phase 2, Multi-Arm Study of Niraparib Administered Alone and in Combination with Pembrolizumab in Patients with Non-Small Cell Lung Cancer

1. Cohort 1(combination of niraparib and pembrolizumab): patients must have tumors with high
PD-L1 expression (TPS ≥ 50%) per local assessment, with no known EGFR-sensitizing
mutation and/or ROS-1 or ALK translocation, and no prior systemic chemotherapy or
PD-1/PD-L1 inhibitor treatment for metastatic NSCLC
2. Cohort 2 (combination of niraparib and pembrolizumab): patients must have tumors with PD-L1
expression (TPS between 1% and 49%) per local assessment, with no known EGFR-sensitizing
mutation and/or ROS-1 or ALK translocations, and no prior systemic chemotherapy or
PD-1/PD-L1 inhibitor treatment for metastatic NSCLC (all histologies)
3. Cohort 3 (single agent niraparib): patients must have metastatic sqNSCLC and have progressed
after both prior platinum-based chemotherapy and prior PD-1 or PD-L1 inhibitor treatment
Specific exclusion criteria for Cohort 1 and 2:
1. Has received systemic therapy for the treatment of advanced stageNSCLC. Completion of
treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed
as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease
2. Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
3. Known hypersensitivity to pembrolizumab components or excipients
4. Known EGFR(exon 19 and 21) mutations, ALK translocations, and/or ROS-1 translocations
5. Active autoimmune disease that required systemic treatment in the past 2 years (ie, with use of
disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy
10
Niraparib TESARO
Clinical Study Protocol 3000-02-001
(eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency, etc.) is not considered a form of systemic treatment
6. Known interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis requiring
steroid treatment
Specific exclusion criteria for Cohort 3:
1. Platinum-treated patients that progressed while on or within less than 8 weeks from the last day
of platinum administration
Phase II
NCT03308942
Cancer
Lung
Basir Haque, M.D.
Tesaro, Inc.
Paul Alderson
  • Kadlec Clinic Hematology and Oncology
  • Kadlec Research