Study D9108C00002 (NeoCOAST) is a platform study assessing the effectiveness and safety of neoadjuvant durvalumab alone or in combination with novel agents in participants with resectable, early-stage (Stage I \[\>2cm\] to IIIA) non-small cell lung cancer (NSCLC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Durvalumab 1500 mg IV will be administered Q4W (on Week 1 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.
Oleclumab 3000 mg IV will be administered Q2W (on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.
Monalizumab 750 mg IV will be administered Q2W (on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.
Research Site
La Jolla, California, United States
Research Site
Fort Myers, Florida, United States
Research Site
Major Pathological Response Rate
Major pathological response rate is defined as percentage of participants with \<=10% residual viable tumor cells in the resected specimen.
Time frame: Day 1 through Day 42
Pathological Complete Response (pCR) Rate
The pCR rate is defined as percentage of participants with no residual viable tumor cells in the resected specimen.
Time frame: Day 1 through Day 42
Feasibility to Surgery
Feasibility to surgery is defined as the percentage of participants who underwent the planned surgery within Days 29 to 42 after Week 1 Day 1.
Time frame: Day 29 to Day 42 after Week 1 Day 1
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Time frame: From Day 1 through Day 105
Number of Participants With Grade 3 or Grade 4 Clinical Laboratory Toxicities
Participants with Grade 3 or Grade 4 clinical laboratory toxicities are reported. Laboratory tests included hematology, coagulation, chemistry, and urinalysis.
Time frame: From Day 1 through Day 105
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Danvatirsen 200 mg IV will be administered on Days 1, 3, and 5 of Week 0 (7-day danvatirsen lead-in period) and later every week (on Week 1 Day 1, Week 2 Day 1, Week 3 Day 1, and Week 4 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.
Leesburg, Florida, United States
Research Site
Baltimore, Maryland, United States
Research Site
Buffalo, New York, United States
Research Site
New York, New York, United States
Research Site
Chattanooga, Tennessee, United States
Research Site
Nashville, Tennessee, United States
Research Site
Houston, Texas, United States
Research Site
Fairfax, Virginia, United States
...and 8 more locations
Number of Participants With Abnormal Vital Signs Reported as TEAEs
Participants with abnormal vital sign reported as TEAEs are reported.
Time frame: From Day 1 through Day 105