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Background Anti-cancer Therapy with Amivantamab Plus Lazertinib for Non-Small Cell Lung Cancer

Taipei Veterans General Hospital, Taipei, Taiwan
Non-Small Cell Lung CancerDexamethasone - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial evaluates if pre-treatment drugs reduce side effects when taking amivantamab and Lazertinib to treat cancer.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Up to 14 months

Cycle 1 Day 1
Percentage of Participants with Adverse Events (AEs) of IRR by Severity at Cycle 1 Day 1
Percentage of Participants with Adverse Events (AEs) of Infusion-related Reactions (IRRs) at Cycle 1 Day 1
Percentage of Participants with Infusion-related Reactions (IRRs)
Time to Complete Infusion for Pre-amivantamab Infusion Medications, IV Amivantamab Infusion, and Post-amivantamab Infusion Medications on Cycle 1 Day 1
Up to 14 months
Duration of Response (DOR)
Overall Response Rate (ORR)
Up to 3 months
Percentage of Participants with Adverse Events (AEs) of IRRs by Severity up to 3 Months
Percentage of Participants with Adverse Events (AEs) of IRRs up to 3 Months
Month 14
Percentage of Participants with IRR by Severity
Percentage of Participants with IRRs
Percentage of Participants with Other Adverse Events (AEs)
Day 1
Percentage of Participants Completing Amivantamab Infusion Within 4 Hours on Cycle 1 Day 1

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Background Anti-cancer Therapy with Amivantamab Plus Lazertinib
1 of 1

Experimental Treatment

120 Total Participants · 1 Treatment Group

Primary Treatment: Background Anti-cancer Therapy with Amivantamab Plus Lazertinib · No Placebo Group · Phase 2

Background Anti-cancer Therapy with Amivantamab Plus LazertinibExperimental Group · 5 Interventions: Dexamethasone, Montelukast, Methotrexate, Amivantamab, Lazertinib · Intervention Types: Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2420
Montelukast
2008
Completed Phase 4
~15460
Methotrexate
2013
Completed Phase 4
~3800
Lazertinib
2021
Completed Phase 2
~340

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 14 months

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
940 Previous Clinical Trials
6,369,983 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
722 Previous Clinical Trials
3,952,141 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Male participants must use a condom during sexual activity that can lead to the transfer of semen to another person for the duration of the study and 3 months after the last dose of study treatment.
If you're a woman using birth control pills, you also need to use a barrier method of contraception.
References

Frequently Asked Questions

Has the combination of amivantamab and lazertinib been endorsed by the Food & Drug Administration?

"The safety of Background Anti-cancer Therapy with Amivantamab Plus Lazertinib is estimated to be a 2, as this is part of Phase 2 clinical trials and there are some data points that confirm its security but none which prove its efficacy." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies yet for participants in this research study?

"Clinicaltrials.gov shows that this trial, which was posted on April 9th 2023 and last updated January 31st of the same year, is not currently recruiting patients. Nevertheless, at present there are 1,319 other clinical trials actively searching for volunteers to take part in their research projects." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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