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 October 23, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
ACTIVE, NOT RECRUITING (See Contacts and Locations)Verified October 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: October 24, 2024
Last Verified: October 2024
History of Changes
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Tracking Information | |
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First Submitted Date | May 19, 2022 |
First Posted Date | May 24, 2022 |
Last Update Posted Date | October 24, 2024 |
Study Start Date | August 5, 2022 |
Actual Primary Completion Date | January 3, 2024 |
Current Primary Outcome Measures(submitted: October 23, 2024) |
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Change History | Complete list of historical versions of study NCT05388669 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures |
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Current Other Outcome Measures | Not Provided |
Descriptive Information | |
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Brief Title | A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer |
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 |
Brief Summary | The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: RandomizedInterventional Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment |
Target Follow-Up Duration | Not Provided |
Biospecimen | Not Provided |
Sampling Method | Not Provided |
Study Population | Not Provided |
Condition |
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Intervention | Drug: Lazertinib Lazertinib tablets will be administered orally. |
Study Groups/Cohorts | Experimental: Arm A: Lazertinib with Amivantamab SC-CFLazertinib 240 milligrams (mg) will be administered orally once daily. Participants will receive amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), 1600 mg/ 2240 mg depending on the body weight by manual injection. Participants benefiting from study treatment after primary analysis may continue to receive access to study treatment within the study by transferring to the long-term extension (LTE) Phase. Intervention:
Experimental: Arm B: Lazertinib with Amivantamab Intravenous (IV) InfusionLazertinib 240 mg will be administered orally once. Participants will receive amivantamab, 1050 mg or 1400 mg depending on the body weight as an IV infusion. Participants benefiting from study treatment after primary analysis may continue to receive access to study treatment within the study by transferring to the LTE Phase. Intervention:
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Publications * | Not Provided |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
Recruitment Information | |
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Recruitment Status | Active, not recruiting |
Actual Enrollment(submitted: October 23, 2024) | 418 |
Anticipated Study Completion Date | December 31, 2025 |
Actual Primary Study Completion Date | January 3, 2024 |
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender | Sexes Eligible for Study: All |
Ages | 18 Years and Older (Adult, Older Adult) |
Accepts Healthy Volunteers | No |
Contacts | Contact information is only displayed when the study is recruiting subjects |
Listed Location Countries | United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, Argentina, Argentina, Argentina, Argentina, Argentina, Argentina, Australia, Australia, Australia, Australia, Australia, Australia, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Brazil, Canada, Canada, China, China, China, China, China, China, China, China, China, China, China, China, China, China, China, China, China, China, China, China, China, China, China, China, China, China, China, China, China, China, China, China, France, France, France, France, Germany, Germany, Germany, Germany, Germany, Germany, Israel, Israel, Israel, Israel, Israel, Italy, Italy, Italy, Italy, Italy, Italy, Italy, Italy, Italy, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Korea, Republic of, Korea, Republic of, Korea, Republic of, Korea, Republic of, Korea, Republic of, Korea, Republic of, Korea, Republic of, Korea, Republic of, Korea, Republic of, Malaysia, Malaysia, Malaysia, Malaysia, Malaysia, Malaysia, Poland, Poland, Poland, Poland, Poland, Portugal, Portugal, Portugal, Portugal, Spain, Spain, Spain, Spain, Spain, Spain, Spain, Spain, Spain, Spain, Spain, Spain, Spain, Spain, Spain, Spain, Taiwan, Taiwan, Taiwan, Taiwan, Taiwan, Taiwan, Taiwan, Taiwan, Thailand, Thailand, Thailand, Turkey, Turkey, Turkey, Turkey, Turkey, Turkey, Turkey, Turkey, Turkey, Turkey, Turkey, United Kingdom, United Kingdom, United Kingdom, United Kingdom |
Administrative Information | |
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NCT Number | NCT05388669 |
Other Study ID Numbers | CR109211 |
Has Data Monitoring Committee | Yes |
U.S FDA-regulated Product | Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No Product Manufactured in and Exported from the U.S.: Not Provided |
IPD Sharing Statement | Plan to Share IPD: Yes |
Responsible Party | Janssen Research & Development, LLC, Janssen Research & Development, LLC |
Study Sponsor | Janssen Research & Development, LLC |
Collaborators | Not Provided |
Investigators | |
PRS Account | Janssen Research & Development, LLC |
Verification Date | October 2024 |