The purpose of this study is to assess the antitumor activity, safety, and tolerability of tislelizumab plus investigational agent(s) with or without chemotherapy. This study is structured as a master protocol with separate sub- studies. Sub-study 1 includes participants with non-small cell lung cancer (NSCLC) with high programmed cell death protein ligand-1 (PD-L1) expression (≥ 50%), and Sub-study 2 includes participants with NSCLC with low or negative (PD-L1) expression (\< 50%).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Administered by intravenous infusion
Administered by intravenous infusion
Administered by intravenous infusion
Investigator's choice; administered by intravenous infusion
Investigator's choice; administered by intravenous infusion
Investigator's choice; administered by intravenous infusion
Investigator's choice; administered by intravenous infusion
Investigator's choice; administered by intravenous infusion
Administered Orally
Valkyrie Clinical Trials
Los Angeles, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States
Providence Portland Medical Center
Portland, Oregon, United States
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States
Confirmed overall response rate (ORR)
ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1
Time frame: Up to 6 months
Progression-free survival (PFS)
PFS is defined as the time from date of randomization, or the first dose for safety lead-in participants , until first documentation of progression or death, whichever comes first, as assessed by the investigator using RECIST v1.
Time frame: Up to 1 year
Duration of Response (DOR)
DOR is defined as the time from the first determination of a confirmed response per RECIST v1.1 until the first documentation of progression or death, whichever comes first as assessed by the investigator
Time frame: Up to 1 year
Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants with a best overall response of a complete response, partial response, or durable stable disease, as assessed by the investigator using RECIST v1.1
Time frame: Up to 6 months
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with a best overall response of complete response, partial response, or stable disease, as assessed by the investigator using RECIST v1.1
Time frame: Up to 6 months
Number of participants with adverse events (AEs)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, vital signs, physical examination findings, and electrocardiogram results.
Time frame: From the first dose of study drug(s) to 90 days after initiation of new anticancer therapy, death, withdrawal of consent, or loss to follow-up, whichever occurs first, up to approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Chris Obrien Lifehouse
Camperdown, New South Wales, Australia
Northern Beaches Hospital
Frenchs Forest, New South Wales, Australia
Port Macquarie Base Hospital
Port Macquarie, New South Wales, Australia
One Clinical Research
Nedlands, Western Australia, Australia
...and 51 more locations