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Monoclonal Antibodies

Amivantamab + TKI for Lung Cancer

Phase 1 & 2
Recruiting
Led By Patil Tejas, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant is ≥ 18 years of age
Participant has histologic or cytologic confirmation of locally advanced (unresectable) or metastatic NSCLC with a known (and documented) ALK, ROS1, or RET fusion based on approved diagnostic testing methods
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 40 months
Awards & highlights

Study Summary

This trial uses drugs to treat lung cancer by blocking pathways that allow cancer to resist current drugs. This could help stop cancer cells from adapting and becoming resistant.

Who is the study for?
Adults with advanced NSCLC who have ALK, ROS1, or RET gene fusions and have seen their cancer progress after at least one TKI treatment. They must be currently on a stable dose of TKI for 3+ months, able to take oral meds, and have a life expectancy over 12 weeks. Excluded are those with certain prior treatments, active infections like HIV or hepatitis B/C, pregnant women, and anyone with severe allergies to study drugs.Check my eligibility
What is being tested?
The trial is testing Amivantamab in combination with current TKI therapies against advanced non-small cell lung cancer (NSCLC) that has specific genetic alterations (ALK, ROS1, RET). The goal is to see if this combo can overcome resistance developed from previous treatments by inhibiting pathways that the cancer cells use to survive.See study design
What are the potential side effects?
Amivantamab may cause side effects such as infusion reactions (like fever or chills), skin rash or itching. There's also a risk of developing conditions affecting the lungs like interstitial lung disease. Side effects vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My advanced lung cancer is confirmed to have ALK, ROS1, or RET fusion.
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I have been on the same TKI medication for at least 3 months due to my cancer progressing.
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I can take care of myself and am up and about more than half of the day.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 40 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the MTD in adult participants with advanced NSCLC
Determine the recommended phase 2 dose in adult participants with advanced NSCLC
Estimate the objective response rate (ORR) of amivantamab in combination with common TKIs used in ALK, ROS1, and RET advanced NSCLC progressing on TKIs
Secondary outcome measures
Collect treatment-emergent adverse events
Collect treatment-related adverse events (TRAEs)
To evaluate the extracranial disease control rate (DCR) among patients treated with amivantamab in combination with concurrent TKI in patients with advanced NSCLC with ALK, ROS1, and RET gene fusions.
+8 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Dose Finding (Safety Lead-In) Cohort (≥80 kg)Experimental Treatment1 Intervention
To estimate the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) in adult participants with advanced NSCLC with ALK, ROS1, and RET gene fusions.
Group II: Dose Finding (Safety Lead-In) Cohort (<80 kg)Experimental Treatment1 Intervention
To estimate the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) in adult participants with advanced NSCLC with ALK, ROS1, and RET gene fusions.
Group III: Dose Expansion Cohort (≥80 kg)Experimental Treatment1 Intervention
To estimate the objective response rate (ORR) of amivantamab in combination with common TKIs used in ALK, ROS1, and RET advanced NSCLC progressing on TKIs.
Group IV: Dose Expansion Cohort (<80 kg)Experimental Treatment1 Intervention
To estimate the objective response rate (ORR) of amivantamab in combination with common TKIs used in ALK, ROS1, and RET advanced NSCLC progressing on TKIs.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,514 Total Patients Enrolled
Janssen Research & Development, LLCIndustry Sponsor
976 Previous Clinical Trials
6,384,680 Total Patients Enrolled
Patil Tejas, MDPrincipal InvestigatorUniversity of Colorado, Denver

Media Library

Amivantamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05845671 — Phase 1 & 2
Lung Cancer Research Study Groups: Dose Finding (Safety Lead-In) Cohort (<80 kg), Dose Finding (Safety Lead-In) Cohort (≥80 kg), Dose Expansion Cohort (<80 kg), Dose Expansion Cohort (≥80 kg)
Lung Cancer Clinical Trial 2023: Amivantamab Highlights & Side Effects. Trial Name: NCT05845671 — Phase 1 & 2
Amivantamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05845671 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals of advanced age permitted to join the clinical trial?

"Patients of legal age (over 18) and not exceeding 90 years old can be enrolled in this clinical trial."

Answered by AI

Am I eligible to enrol in this clinical trial?

"Eligible participants of this lung cancer trial must be aged 18-90, with 12 patients being sought."

Answered by AI

Are there any current openings on this experiment for participants?

"According to the details hosted on clinicaltrials.gov, this particular medical trial is not open for recruitment at present. It was first posted on December 1st 2023 and its last update occurred April 25th of the same year. Fortunately, there are currently 1927 other trials that are accepting patients right now."

Answered by AI

Who else is applying?

What site did they apply to?
Colorado Research Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Amivantamab With Tyrosine Kinase Inhibitors (TKI) for Advanced NSCLC With ALK, ROS1, or RET Alterations
2023. "Amivantamab With Tyrosine Kinase Inhibitors (TKI) for Advanced NSCLC With ALK, ROS1, or RET Alterations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05845671.
~8 spots leftby Jan 2027
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