A Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy
ClinicalTrials.gov processed this data on August 13, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
ACTIVE, NOT RECRUITING (See Contacts and Locations)Verified August 2024 by Janssen Research & Development, LLC
Sponsor
Janssen Research & Development, LLCInformation Provided by (Responsible Party)
Janssen Research & Development, LLCClinicaltrials.gov Identifier
NCT05388669Other Study ID Numbers: CR109211
First Submitted: May 19, 2022
First Posted: May 24, 2022
Last Update Posted: August 14, 2024
Last Verified: August 2024
History of Changes
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Study Description
Not ProvidedCondition or Disease | Intervention/Treatment |
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Study Design
Study Type | Interventional |
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Actual Enrollment | 418 participants |
Design Allocation | Randomized |
Interventional Model | Parallel Assignment |
Masking | None (Open Label) |
Primary Purpose | Treatment |
Official Title | A Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy |
Study Start Date | August 5, 2022 |
Actual Primary Completion Date | January 3, 2024 |
Anticipated Study Completion Date | January 9, 2025 |
Groups and Cohorts
Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- For All Regions Other Than the European Union (EU) and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State on Cycle 4 Day 1 [Cycle 4 Day 1 (28 days cycle)] Ctrough is the observed serum concentration of Amivantamab at steady state on Cycle 4 Day 1 immediately prior to the next drug administration.
- For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab at Pre-dose on Cycle 2 Day 1 [Cycle 2 Day 1 (28 days cycle)] Ctrough is the observed serum concentration of Amivantamab at pre-dose on Cycle 2 Day 1 immediately prior to the next drug administration.
- Area Under the Concentration Time Curve from Day 1 to Day 15 (AUC[Day 1-15]) of Amivantamab of Cycle 2 [Cycle 2 Day 1 to Cycle 2 Day 15 (28 days cycle)] AUC(Day 1-15) defined as area under the concentration time curve from Cycle 2 Day 1 to Day 15, will be reported.
Secondary Outcome Measures
- Objective Response Rate (ORR) [Up to 1 year 11 months] ORR is defined as the percentage of participants who achieve either a CR or PR as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.1).
- Progression-Free Survival (PFS) [Up to 1 year 11 months] PFS is defined as the time from randomization until the date of objective disease progression or death, whichever comes first, based on RECIST version 1.1.
- Duration of Response (DOR) [Up to 1 year 11 months] The DoR 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 to Response (TTR) [Up to 1 year 11 months] Time to response (that is time to first response) is defined as the time from the date of randomization to the date of first documentation of a response (PR or CR) prior to any disease progression and subsequent anticancer therapy, as defined by BICR using RECIST version 1.1., for participants who have PR or CR as their best response.
- Number of Participants With Adverse Events (AEs) [Up to 4 year 11 months] An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. This outcome includes participants continuing in the LTE Phase for whom, after the primary analysis, data were collected until a discontinuation criterion is met, or until 3 years after local marketing authorization is obtained.
- Number of Participants with AEs by Severity [Up to 4 year 11 months] Severity 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. This outcome includes participants continuing in the LTE Phase for whom, after the primary analysis, data were collected until a discontinuation criterion is met, or until 3 years after local marketing authorization is obtained.
- Number of Participants with Clinical Laboratory Abnormalities [Up to 4 year 11 months] Number of participants with clinical laboratory abnormalities (serum Chemistry, hematology, coagulation, and urinalysis) will be reported. This outcome includes participants continuing in the LTE Phase for whom, after the primary analysis, data were collected until a discontinuation criterion is met, or until 3 years after local marketing authorization is obtained.
- Number of Participants with Clinical Laboratory Abnormalities by Severity [Up to 4 year 11 months] Number of participants with clinical laboratory abnormalities by severity (serum Chemistry, hematology, coagulation, and urinalysis) will be reported. Severity 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. This outcome includes participants continuing in the LTE Phase for whom, after the primary analysis, data were collected until a discontinuation criterion is met, or until 3 years after local marketing authorization is obtained.
- Number of Participants Infusion Related Reactions (IRRs) [Up to 1 year 11 months] Number of participants with IRRs will be reported.
- Number of Participants with Infusion Related Reactions (IRRs) by Severity [Up to 1 year 11 months] Number of participants with IRRs by severity will be reported.
- For All Regions Other Than the EU and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Pre-dose on Cycle 2 Day 1 [Cycle 2 Day 1 (28 days cycle)] The Ctrough is the observed serum concentration of Amivantamab at pre-dose on Cycle 2 Day 1 immediately prior to the next drug administration.
- For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State on Cycle 4 Day 1 [Cycle 4 Day 1 (28 days cycle)] The Ctrough is the observed serum concentration of Amivantamab at steady state on Cycle 4 Day 1 immediately prior to the next drug administration.
- Model-Predicted Area Under the Concentration Time Curve from Day 1 to Day 15 (AUC[Day 1-15]) of Amivantamab at Steady State of Cycle 4 [From Cycle 4 Day 1 to Cycle 4 Day 15 (28 days cycle)] Model-predicted AUC(Day 1-15) defined as area under the concentration time curve from Cycle 4 Day 1 to Day 15, will be reported.
- Percentage of Participants with Presence of Anti-amivantamab Antibodies and Anti-rHuPH20 Antibodies [Up to 1 year 11 months] Percentage of participants with presence of anti-amivantamab antibody anti-rHuPH20 antibodies will be reported.
- Percentage of Participants with Cancer Therapy Satisfaction as Assessed by Therapy Administration Satisfaction Questionnaire (TASQ) [Up to 1 year 11 months] Percentage of participants with cancer therapy satisfaction in will be assessed using the modified TASQ. The modified TASQ is an 11-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.
- Change from Baseline in TASQ as Assessed Over Time [Up to 1 year 11 months] Change from baseline in TASQ as assessed Over time will be reported. The modified TASQ is an 11-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.
- Participant Chair Time [Up to 1 year 11 months] Participant chair time will be assessed by time and motion analysis.
- Duration of Treatment Administration [Up to 1 year 11 months] Duration of treatment administration will be assessed by time and motion analysis.
- Active HCP Time For Drug Preparation, Treatment Administration and Posttreatment Monitoring [Up to 1 year 11 months] Active health care professional time for drug preparation, treatment administration, and posttreatment monitoring will be assessed by time and motion analysis.
- Participant Time in Treatment Room [Up to 1 year 11 months] Participant time in treatment room will be assessed by time and motion analysis.
Eligibility Criteria
Ages Eligible for Study | 18 Years and Older (Adult, Older Adult) |
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Sexes Eligible for Study | All |
Accepts Healthy Volunteers | No |
Inclusion Criteria |
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Exclusion Criteria |
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Contacts and Locations
Sponsors and Collaborators | Janssen Research & Development, LLC |
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Investigators |
More Information
Additional Relevant MeSH Terms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Neoplasms by Site
- Neoplasms
- Lung Diseases
- Respiratory Tract Diseases
- Carcinoma, Bronchogenic
- Bronchial Neoplasms