The main purpose of this study is to evaluate the safety and activity of the study drug known as LY3023414 in combination with necitumumab in participants with metastatic squamous non-small cell lung cancer (NSCLC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Administered orally
Administered IV
Southern Cancer Center, P.C.
Mobile, Alabama, United States
Ironwood Cancer & Research Centers
Chandler, Arizona, United States
Comprehensive Cancer Care and Research Institute of Colorado
Percentage of Participants With a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at 6 Months: Disease Control Rate (DCR)
RECIST v 1.1 was used to assess tumor response.The 6-month DCR was defined as the number of participants with PFS \> 6 months (or 26 weeks, to accommodate the scheduled tumor assessment at week 24 be delayed by up to 2 weeks) divided by number of participants with baseline tumor assessment. Target Lesions:CR was defined as the disappearance of all target lesions. PR was at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference the smallest (nadir) sum of diameters since the treatment started. Non-Target Lesions:CR was defined as disappearance of all non-target lesions and normalization of tumor markers.All lymph nodes must be non-pathological in size (\<10 millimeters(mm) short axis).SD was defined as the persistence of one or more non-target lesions and/or persistence of tumor marker level above the normal limits.
Time frame: 6 Months
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)
RECIST v 1.1 was used to assess tumor response. ORR for a given participant was based on objective responses determined from data obtained up to: progression, the last evaluable assessment in the absence of progression, or initiation of subsequent anticancer therapy. Participants for whom an objective response cannot be determined or for who the best objective response is not evaluable (NE) were considered non-responders. Target Lesions: CR was defined as the disappearance of all target lesions. PR was at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Non-Target Lesions: CR was defined as disappearance of all non-target lesions and normalization of tumor markers. All lymph nodes must be non-pathological in size (\<10 mm short axis). The ORR percentage was calculated as the number of participants with best objective response of CR or PR divided by the number of participants with measurable disease at baseline.
Time frame: Baseline to Objective Disease Progression or Initiation of Subsequent Anticancer Therapy (Up To 3 Months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Englewood, Colorado, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Florida Cancer Specialists
St. Petersburg, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
Research Medical Center
Kansas City, Missouri, United States
Oncology Hematology Care Inc.
Cincinnati, Ohio, United States
Chattanooga Oncology Hematology
Chattanooga, Tennessee, United States
...and 4 more locations
Progression Free Survival (PFS)
PFS was defined as the time from enrollment until the date of disease progression per RECIST v 1.1 or death by any cause.Participants who had not progressed or died at the time of assessment were censored at the time of the last date of tumor assessment.Participants who are enrolled but do not receive treatment and participants who have no evaluable visits will be censored on day 1.Participants who received new anti-cancer therapy before disease progression or death will be censored to the last tumor assessment date prior to the new anti-cancer therapy. Target Lesions:PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest(nadir) sum since the treatment started, or the appearance of one or more new lesions. Requires not only 20% increase, but absolute increase of a minimum of 5 mm over sum. Non-Target Lesions(NTL):PD is defined as appearance of one or more new lesions and/or unequivocal progression of existing NTL.
Time frame: Enrollment to Measured Progressive Disease or Death from Any Cause (Up To 12 Months)
Overall Survival (OS)
OS was defined as the time from enrollment until the date of death by any cause. Participants lost follow up or did not die at the time of assessment were censored at the time of the last known alive date.
Time frame: Enrollment to Death from Any Cause (Up To 16 Months)
Pharmacokinetics (PK): Minimum Concentration (Cmin) of LY3023414 and Necitumumab
Minimum Concentration (Cmin) of LY3023414 and Necitumumab
Time frame: Cycle 1 Day 8, and Cycle 3 Day 8 (pre-dose, end of necitumumab infusion and 1 hour post-necitumumab infusion), Cycle 2 Day 1, Cycle 4 Day 1
Pharmacokinetics: Maximum Concentration (Cmax) of LY3023414 and Necitumumab
Maximum Concentration (Cmax) of LY3023414 and Necitumumab
Time frame: Cycle 1 Day 8, and Cycle 3 Day 8 (pre-dose, end of necitumumab infusion and 1 hour post-necitumumab infusion)