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Amivantamab for Non-Small Cell Lung Cancer

Klinikum der Universitaet Muenchen, München, Germany
Non-Small Cell Lung CancerAmivantamab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will compare the effectiveness of two different cancer treatments in people with lung cancer that has continued to grow despite treatment with osimertinib.

Treatment Effectiveness

Phase-Based Effectiveness

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

Similar Trials

1
Amivantamab
1
Binimetinib
1
Lazertinib

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: Up to 48 months

Up to 17 months
Duration of Response (DoR)
European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Score
Intracranial PFS
Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NSCLC-SAQ)
Number of Participants with Anti-Amivantamab Antibodies
Objective Response as Assessed by BICR
Patient Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF)
Plasma Concentration of Lazertinib
Progression-Free Survival (PFS) According to RECIST v1.1 Guidelines as Assessed by Blinded Independent Central Review (BICR)
Progression-Free Survival After First Subsequent Therapy (PFS2)
Serum Concentration of Amivantamab
Time to Subsequent Therapy (TTST)
Time to Symptomatic Progression (TTSP)
Up to 48 months
Number of Participants with Adverse Events (AEs)
Number of Participants with Clinical Laboratory Abnormalities
Overall Survival (OS)

Trial Safety

Phase-Based Safety

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

Similar Trials

1
Amivantamab
1
Binimetinib
1
Lazertinib

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

6 Treatment Groups

Arm B: CP (Carboplatin and Pemetrexed)
1 of 6
Arm C2 (Extension Cohort): ACP
1 of 6
Arm A: LACP/ACP-L
1 of 6
Arm A2 (Extension Cohort): ACP-L
1 of 6
Arm A: LACP (Lazertinib, Amivantamab, Carboplatin, and Pemetrexed)
1 of 6
Arm C: ACP (Amivantamab, Carboplatin and Pemetrexed)
1 of 6

Active Control

Experimental Treatment

690 Total Participants · 6 Treatment Groups

Primary Treatment: Amivantamab · No Placebo Group · Phase 3

Arm C2 (Extension Cohort): ACPExperimental Group · 3 Interventions: Amivantamab, Carboplatin, Pemetrexed · Intervention Types: Drug, Drug, Drug
Arm A: LACP/ACP-LExperimental Group · 4 Interventions: Amivantamab, Carboplatin, Pemetrexed, Lazertinib · Intervention Types: Drug, Drug, Drug, Drug
Arm A2 (Extension Cohort): ACP-LExperimental Group · 4 Interventions: Amivantamab, Carboplatin, Pemetrexed, Lazertinib · Intervention Types: Drug, Drug, Drug, Drug
Arm A: LACP (Lazertinib, Amivantamab, Carboplatin, and Pemetrexed)Experimental Group · 4 Interventions: Amivantamab, Carboplatin, Pemetrexed, Lazertinib · Intervention Types: Drug, Drug, Drug, Drug
Arm C: ACP (Amivantamab, Carboplatin and Pemetrexed)Experimental Group · 3 Interventions: Amivantamab, Carboplatin, Pemetrexed · Intervention Types: Drug, Drug, Drug
Arm B: CP (Carboplatin and Pemetrexed)ActiveComparator Group · 2 Interventions: Carboplatin, Pemetrexed · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Pemetrexed
FDA approved
Lazertinib
Not yet 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
940 Previous Clinical Trials
6,369,413 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
722 Previous Clinical Trials
3,951,571 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

Are there any similar studies to Amivantamab that have been done in the past?

"Amivantamab was first trialled at Edinburgh Royal Hospital for Sick Children in 2002. As of now, 1043 studies have completed. 805 of these studies are ongoing, a large number of which are based in East Brunswick, New Jersey." - Anonymous Online Contributor

Unverified Answer

What are Amivantamab's most popular indications?

"Amivantamab is commonly used as an initial treatment, but can also be effective for more advanced forms of thymoma, [testicular cancer](https://www.withpower.com/clinical-trials/testicular-cancer), neuroendocrine carcinoma, and other cancers." - Anonymous Online Contributor

Unverified Answer

What is the status of Amivantamab's FDA application?

"Amivantamab has been studied in earlier phases and has been shown to be safe and effective, so it received a score of 3." - Anonymous Online Contributor

Unverified Answer

What is the total number of active sites for this trial?

"Right now, this clinical trial is looking for participants from 32 different sites. These locations include cities such as East Brunswick, Dallas and Tucson. If you are considering participating, try and pick a location that is close to minimize travel." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies in this research for people who want to participate?

"Yes, the information on clinicaltrials.gov states that this trial is still looking for patients. The trial was first posted on 11/17/2021 and was last updated on 11/9/2022. Currently, the trial has 32 locations and is looking for 600 participants." - 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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