1. Part A: Subjects will receive Patritumab or placebo with erlotinib. Progression-free survival will be the primary outcome. Subjects will need to have Epidermal Growth Factor Receptor (EGFR) wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2 (Human Epidermal Growth Factor Receptor 2), anti-HER3, or anti-HER4 therapy. Subjects may have high heregulin or low heregulin. 2. Part B: Subjects will receive Patritumab or placebo with erlotinib. Overall survival will be the primary outcome. Subjects will need to have EGFR wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy. Only subjects with high heregulin will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
145
Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks)
Oral erlotinib 150 mg/day
Placebo infusion every 3 weeks
Unnamed facility
Glendale, Arizona, United States
Unnamed facility
Duarte, California, United States
Unnamed facility
La Verne, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
Part A: Progression Free Survival (PFS) in Heregulin-high Participants
PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause. Kaplan-Meier Estimate. Confidence interval (CI) for median was computed using the Brookmeyer-Crowley method. 80% confidence interval is included in the data table.
Time frame: by trial termination (at 20 months)
Part A: Progression Free Survival (PFS) in Heregulin-low Participants
PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause. Kaplan-Meier Estimate. Confidence interval (CI) for median was computed using the Brookmeyer-Crowley method. 80% confidence interval is included in the data table.
Time frame: by trial termination (at 20 months)
Part B: Overall Survival
Percentage of participants still alive at the end of Part B
Time frame: 4 years
Part A: Overall Survival in HRG High Participants
Key secondary efficacy endpoint: Percentage of participants who survived for the length of the trial
Time frame: by trial termination (at 20 months)
Part A: Key Secondary Efficacy Endpoint: Overall Survival in HRG Low Participants
Key secondary efficacy endpoint: Percentage of participants who survived for the length of the trial
Time frame: by trial termination (at 20 months)
Part B: Key Secondary Efficacy Endpoint: PFS, TTD
PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (TTD, as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause.
Time frame: 4 years
Part A: Objective Response Rate (ORR) in HRG High Participants
Key secondary efficacy endpoint: Objective response is defined as percentage of participants achieving complete response (CR) or partial response (PR) Denominator for percentages is the number of subjects with measurable disease in the full analysis set. The best overall response is the best response \[in the order of CR, PR, stable disease (SD), and progressive disease (PD)\] among all overall responses recorded from the start of treatment until the subject withdraws from the study. If there is no post-baseline tumor assessment or all post-baseline tumor assessments with overall response being Inevaluable captured in the CRF, the best overall response is classified as Inevaluable.
Time frame: by trial termination (at 20 months)
Part A: Objective Response Rate (ORR) in HRG Low Participants
Key secondary efficacy endpoint: Objective response is defined as percentage of participants achieving complete response or partial response Denominator for percentages is the number of subjects with measurable disease in the full analysis set. The best overall response is the best response (in the order of CR, PR, SD, and PD) among all overall responses recorded from the start of treatment until the subject withdraws from the study. If there is no post-baseline tumor assessment or all post-baseline tumor assessments with overall response being Inevaluable captured in the CRF, the best overall response is classified as Inevaluable.
Time frame: by trial termination (at 20 months)
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Port Saint Lucie, Florida, United States
Unnamed facility
Tampa, Florida, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Maywood, Illinois, United States
Unnamed facility
Goshen, Indiana, United States
...and 88 more locations