The purpose of this study is to identify the recommended dose of vudalimab to be used in combination with chemotherapy (Part 1) and to evaluate the efficacy and safety of vudalimab plus standard of care chemotherapy relative to pembrolizumab plus chemotherapy (Part 2) as first-line treatment in patients with nonsquamous non-small cell lung cancer (NSCLC).
This is a Phase 1b/2 study, multicenter, open-label, randomized study in patients with nonsquamous non-small cell lung cancer without prior treatment for metastatic disease. Part 1 is designed to identify the recommended Phase 2 dose (RP2D) of vudalimab, an anti-PD-1/CTLA-4 bispecific antibody, in combination with standard of care (SOC) chemotherapy. Part 2 will evaluate the efficacy and safety vudalimab, at the RP2D, plus SOC relative to pembrolizumab (anti-PD-1) plus SOC chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Vudalimab intravenous + carboplatin intravenous + pemetrexed intravenous
Pembrolizumab intravenous + carboplatin intravenous + pemetrexed intravenous
Palo Verde Cancer Specialists
Glendale, Arizona, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
Part 1: Recommended Phase 2 dose of vudalimab in combination with chemotherapy
Incidence of treatment-emergent adverse events and treatment-related adverse events leading to discontinuation of treatment
Time frame: Day 1 to Day 21
Part 2: Progression free survival
Progressive disease per RECIST 1.1 or death, whichever comes first
Time frame: Day 1 to 2.5 years
Antitumor activity
Objective response rate as determined by investigator, duration of response (Part 1 and Part 2)
Time frame: Day 1 to 1.4 years
Changes in circulating tumor DNA (ctDNA)
Examine ctDNA changes as a surrogate marker for disease burden (Part 1 and Part 2)
Time frame: Day 1 to 1.4 years
Maximum Serum Drug Concentration (Cmax)
(Part 1 and Part 2)
Time frame: Day 1 to 1.4 years
Trough Serum Drug Concentration (Ctrough)
(Part 1 and Part 2)
Time frame: Day 1 to 1.4 years
Area Under the Concentration-time Curve (AUC)
(Part 1 and Part 2)
Time frame: Day 1 to 1.4 years
Overall survival
Time to death from any cause (Part 2)
Time frame: Day 1 to 2.5 years
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Hematology Associates of Fredericksburg
Fredericksburg, Virginia, United States
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, Belgium
St. Lukes (Agios Loucas) Hospital
Thessaloniki, Greece
Hospital Sultan Ismail
Johor Bahru, Malaysia
Hospital Umum Sarawak
Kuching, Malaysia
Institut Kanser Negara
Putrajaya, Malaysia
The Netherlands Cancer Institute - Antoni van Leeuwenhoek
Amsterdam, North Holland, Netherlands
ULS do Alto Ave, EPE - Hospital da Senhora da Oliveira Guimarães
Guimarães, Portugal
...and 7 more locations
Incidence of treatment-emergent adverse events
Time frame: Time Frame: Day 1 to 1.4 years]