The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation \[SC-CF\]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
520
Amivantamab will be administered subcutaneously by manual injection.
Lazertinib will be administered as an oral tablet.
Carboplatin will be administrated by IV infusion.
Pemetrexed will be administered by IV infusion.
DOAC will be administered orally.
LMWH will be administered subcutaneously.
University of California at San Diego
La Jolla, California, United States
RECRUITINGUniversity of California Irvine
Orange, California, United States
RECRUITINGStanford Cancer Institute
Stanford, California, United States
RECRUITINGJohns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
All Cohorts Except Cohort 4: Objective Response Rate (ORR) Based on Investigator Assessment (INV)
ORR based on INV will be reported. ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as determined by investigator.
Time frame: Up to 1 year 6 months
Cohort 4: Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.
Time frame: Up to approximately 4 years and 9 months
Cohort 4: Number of Participants with AEs by Severity
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Time frame: Up to approximately 4 years and 9 months
Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values
Number of participants with abnormalities in clinical laboratory values (which includes serum chemistry, hematology, coagulation, urinalysis, and serology) will be reported.
Time frame: Up to approximately 4 years and 9 months
Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values by Severity
Number of participants with laboratory values abnormalities which includes serum chemistry, hematology, coagulation, urinalysis, and serology) by severity will be reported. Severity of laboratory values abnormalities will be graded according to the NCI-CTCAE version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Time frame: Up to approximately 4 years and 9 months
All Cohorts Except Cohort 4: Number of Participants with AEs
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Number of Participants with AEs by Severity
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values
Number of participants with abnormalities in clinical laboratory values (which includes serum chemistry, hematology, coagulation, urinalysis, and serology) will be reported.
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values by Severity
Number of participants with abnormalities in clinical laboratory values which includes serum chemistry, hematology, coagulation, urinalysis, and serology) by severity will be reported. Severity of laboratory values abnormalities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: ORR Based on Independent Central Review (ICR)
ORR based on ICR will be reported. The ORR is defined as the percentage of participants who achieve a CR or PR, based on RECIST version 1.1, as confirmed by ICR.
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Baptist Lynn Cancer Institute
Boca Raton, Florida, United States
COMPLETEDMount Sinai Medical Center
Miami Beach, Florida, United States
RECRUITINGAdventHealth
Orlando, Florida, United States
RECRUITINGH. Lee Moffitt Cancer & Research Institute
Tampa, Florida, United States
COMPLETEDUniversity of Kansas Cancer Center
Westwood, Kansas, United States
RECRUITINGSidney Kimmel Cancer Center - Bayview Campus
Baltimore, Maryland, United States
RECRUITING...and 100 more locations
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Duration of Response (DoR) Based on Investigator Assessment (INV)
DoR based on INV is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR.
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Time to Response (TTR) Based on INV
TTR (that is, time to first response) based on INV is defined as the time from the first dose of study treatment to the date of first documentation of a response (PR or CR) prior to any disease progression and subsequent anticancer therapy, based on RECIST version 1.1., for participants who have PR or CR as their best response.
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants achieving CR or PR, or durable standard deviation (SD) of a duration of at least 11 weeks as defined by RECIST version 1.1.
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Progression-free Survival (PFS)
The PFS is defined as the time from the first dose of study treatment until the date of objective disease progression or death, whichever comes first, based on RECIST version 1.1.
Time frame: Up to 3 years
All Cohorts Except Cohort 4: Overall Survival (OS)
The OS is defined as the time from the first dose of study treatment until the date of death due to any cause.
Time frame: Up to approximately 4 years
All Cohorts Except Cohort 4: Number of Participants with Venous Thromboembolic Events (VTE)
Number of participants with adverse events of VTE (pulmonary embolism and deep vein thrombosis) will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Number of Participants with Venous Thromboembolic Events (VTE) by Severity
Number of participants with adverse events of VTE (pulmonary embolism and deep vein thrombosis) by severity will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death).
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Serum Concentration Immediately Prior to the Next Dose Administration (Ctrough) of Amivantamab
Ctrough is defined as the serum concentration of amivantamab immediately prior to the next drug administration.
Time frame: Cycle 2 Day 1 of 28-day cycle
Cohort 4: Cancer Therapy Satisfaction as Assessed by Modified Therapy Administration Satisfaction Questionnaire - Intravenous (TASQ-IV)
Patient-reported outcome (PRO): Cancer therapy satisfaction will be assessed using the modified TASQ-IV. The modified TASQ is a 12-item questionnaire measuring the impact of each mode of treatment administration on five domains: physical impact, psychological impact, impact on activities of daily living, convenience, and satisfaction. Each of the domain/scale scores is scored on a 1-100 scale, where 0 is worst and 100 is best.
Time frame: Up to 1 year 6 months
Cohort 4: Cancer Therapy Satisfaction as Assessed by Modified Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC)
PRO: Cancer therapy satisfaction will be assessed using the modified TASQ-SC. The modified TASQ is a 12-item questionnaire measuring the impact of each mode of treatment administration on five domains: physical impact, psychological impact, impact on activities of daily living, convenience, and satisfaction. Each of the domain/scale scores is scored on a 1-100 scale, where 0 is worst and 100 is best.
Time frame: Up to 1 year 6 months
Cohort 4: Patient-reported Status as Assessed by Patient Global Impression of Change (PGIC) Scale Score
Patient-reported status as assessed by PGIC scale score will be reported. The PGIC is an assessment of the participant's overall sense of whether there has been a change since starting treatment. The PGIC is a 7-point response scale. Participants will be asked to rate their current fatigue as compared to when they started the study, using the following 7-point scale: 1 = Much better, 2 = Moderately better, 3 = A little better, 4 = No change, 5 = A little worse, 6 = Moderately worse, and 7 = Much worse.
Time frame: Up to 1 year 6 months
Cohort 4: Patient-reported Status as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score
Patient-reported status as assessed by PGIS scale score will be reported. The PGIS is an assessment of lung cancer severity at a given point in time. The PGIS is a 5-point response scale. Participants will be asked to rate their fatigue over the past 7 days using the following 5-point scale: 1 = None, 2 = Mild, 3 = Moderate, 4 = Severe, and 5 = Very severe.
Time frame: Up to 1 year 6 months