A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients With Advanced or Metastatic Solid Tumors Including EGFR-mutated Non-Small Cell Lung Cancer
Summary
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).
Arms & interventions
- DrugAmivantamab
Amivantamab will be administered subcutaneously by manual injection.
- DrugLazertinib
Lazertinib will be administered as an oral tablet.
- DrugCarboplatin
Carboplatin will be administrated by IV infusion.
- DrugPemetrexed
Pemetrexed will be administered by IV infusion.
- DrugDirect Oral Anticoagulant (DOAC)
DOAC will be administered orally.
- DrugLow Molecular Weight Heparin (LMWH)
LMWH will be administered subcutaneously.
Outcome measures
Primary
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
Secondary
All Cohorts Except Cohort 4: Number of Participants with AEs
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Number of Participants with AEs by Severity
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values by Severity
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: ORR Based on Independent Central Review (ICR)
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Duration of Response (DoR) Based on Investigator Assessment (INV)
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Time to Response (TTR) Based on INV
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Clinical Benefit Rate (CBR)
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Progression-free Survival (PFS)
Time frame: Up to 3 years
All Cohorts Except Cohort 4: Overall Survival (OS)
Time frame: Up to approximately 4 years
All Cohorts Except Cohort 4: Number of Participants with Venous Thromboembolic Events (VTE)
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Number of Participants with Venous Thromboembolic Events (VTE) by Severity
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
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)
Time frame: Up to 1 year 6 months
Cohort 4: Cancer Therapy Satisfaction as Assessed by Modified Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC)
Time frame: Up to 1 year 6 months
Cohort 4: Patient-reported Status as Assessed by Patient Global Impression of Change (PGIC) Scale Score
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
Time frame: Up to 1 year 6 months
Eligibility criteria
Study locations (26)
University of California at San Diego
La Jolla, California, 92093
University of California Irvine
Orange, California, 92868
Stanford Cancer Institute
Stanford, California, 94305
Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Baptist Lynn Cancer Institute
Boca Raton, Florida, 33486
Mount Sinai Medical Center
Miami Beach, Florida, 33140
AdventHealth
Orlando, Florida, 32804
H. Lee Moffitt Cancer & Research Institute
Tampa, Florida, 33612
University of Kansas Cancer Center
Westwood, Kansas, 66205
Sidney Kimmel Cancer Center - Bayview Campus
Baltimore, Maryland, 21224
Boston Medical Center
Boston, Massachusetts, 02118
Washington University School Of Medicine
St Louis, Missouri, 63110
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Hematology-Oncology Associates of CNY
East Syracuse, New York, 13057
Novant Health 1
Charlotte, North Carolina, 28204
Novant Health
Winston-Salem, North Carolina, 27106
Cleveland Clinic 1
Cleveland, Ohio, 44111
Cleveland Clinic
Cleveland, Ohio, 44195
Cleveland Clinic 2
Mayfield Heights, Ohio, 44124
Cleveland Clinic 3
Warrensville Heights, Ohio, 44122
The Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Providence Regional Cancer Partnership
Everett, Washington, 98201
Virginia Mason Medical Center
Seattle, Washington, 98101
Swedish Cancer Institute
Seattle, Washington, 98104