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Amivantamab for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Hosp. Univ. 12 De Octubre, Madrid, SpainNon-Small Cell Lung CancerAmivantamab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare how effective amivantamab is at treating NSCLC with EGFR Exon 20ins mutations, compared to chemotherapy alone. The metric for success is progression-free survival (PFS).

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Amivantamab
1
Lazertinib
1
Ami-LC

Study Objectives

1 Primary · 14 Secondary · Reporting Duration: Up to 48 months

Up to 18 months
Progression-Free Survival (PFS) According to RECIST v1.1 as Assessed by Blinded Independent Central Review (BICR)
Up to 48 months
Duration of Response (DoR)
European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
Incidence and Severity of Adverse Events (AEs)
Number of Participants with Anti-Amivantamab Antibodies
Number of Participants with Clinical Laboratory Abnormalities
Number of Participants with Physical Examination Abnormalities
Number of Participants with Vital Signs Abnormalities
Objective Response Rate (ORR)
Overall Survival (OS)
Patient Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF)
Progression-Free Survival After First Subsequent Therapy (PFS2)
Serum Concentration of Amivantamab
Time to Subsequent Therapy (TST)
Time to Symptomatic Progression (TTSP)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Amivantamab
1
Lazertinib
1
Ami-LC

Trial Design

2 Treatment Groups

Arm B: Chemotherapy Alone
1 of 2
Arm A: Amivantamab + Chemotherapy
1 of 2

Experimental Treatment

308 Total Participants · 2 Treatment Groups

Primary Treatment: Amivantamab · No Placebo Group · Phase 3

Arm B: Chemotherapy AloneExperimental Group · 2 Interventions: Carboplatin, Pemetrexed · Intervention Types: Drug, Drug
Arm A: Amivantamab + ChemotherapyExperimental Group · 3 Interventions: Amivantamab, Carboplatin, Pemetrexed · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Pemetrexed
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 48 months

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
934 Previous Clinical Trials
6,368,923 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
717 Previous Clinical Trials
3,951,064 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Colorado100.0%
How old are they?
65+100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References

Frequently Asked Questions

Are there any slots open for this research project?

"That is correct. The listing on clinicaltrials.gov currently includes this trial, which was first posted on October 13th 2020 and last updated November 9th 2020. They are seeking 300 participants total, across 18 different sites." - Anonymous Online Contributor

Unverified Answer

How many total patients are being included in this experiment?

"To move forward, this clinical trial needs 300 patients that meet the pre-specified inclusion criteria. Luckily, patients can enroll at Texas Oncology Pa in Tyler, Texas or Pacific Shores Medical Group in Long Beach, California." - Anonymous Online Contributor

Unverified Answer

Has Amivantamab been used in other research trials before?

"Amivantamab was first researched in 2002 at Edinburgh Royal Hospital for Sick Children. In the last two decades, there have been 1037 completed clinical trials. As of now, 800 are recruiting patients with a significant portion being based in Tyler, Texas." - Anonymous Online Contributor

Unverified Answer

Are there any other continents where this research study is taking place?

"Currently, this trial is enrolling patients in Tyler, Texas at Texas Oncology Pa, Long Beach, California at Pacific Shores Medical Group, Orange, Georgia at University of California, Irvine, and 18 other locations." - Anonymous Online Contributor

Unverified Answer

What are some potential side effects of Amivantamab?

"Amivantamab's safety has been well-documented in Phase 3 clinical trials, and it has been shown to be effective in multiple rounds of testing. Therefore, we believe it to be a safe medication." - Anonymous Online Contributor

Unverified Answer

What are the off-label benefits of Amivantamab?

"Amivantamab is often the first intervention doctors recommend to patients. It is also an effective treatment for advanced thymoma, advanced testicular cancer, and carcinoma, neuroendocrine." - 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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