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Monoclonal Antibodies

Amivantamab for Lung Cancer (CHRYSALIS Trial)

Phase 1

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) that is metastatic or unresectable

Participants must have either progressed after prior standard of care therapy for metastatic disease, or be ineligible for, or have refused all other currently available therapeutic options

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cycle 1 day 1: predose through eot (30 [+7] days after last dose [cycle 4 day 15]) (each cycle is of 28 days)

Awards & highlights

CHRYSALIS Trial Summary

This trial is testing a new drug to treat NSCLC, which is the most common type of lung cancer. The purpose of the study is to see if the drug is safe and effective, and to find the best dose.

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer (NSCLC). Participants must have specific types of NSCLC, be eligible for certain chemotherapy treatments, and may have progressed after standard care or refused other options. They should not have had recent cancer treatment or major surgery and must be in good physical condition without serious illnesses that could affect study participation.Check my eligibility

What is being tested?

The trial is testing Amivantamab alone and combined with Lazertinib, as well as with Carboplatin and Pemetrexed chemotherapy. It aims to find the safest doses for these combinations over a 21-day cycle, assess how the body processes them, and evaluate their preliminary effectiveness against NSCLC.See study design

What are the potential side effects?

Potential side effects include reactions at the infusion site, fatigue, nausea from chemotherapy drugs like Carboplatin and Pemetrexed; Amivantamab can cause skin rash or changes in liver function tests. Each person's experience may vary.

CHRYSALIS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer cannot be removed by surgery and has spread.

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My cancer has worsened after treatment, or I can't receive/have refused all other treatments.

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I have NSCLC that cannot be removed by surgery and agree to receive carboplatin, pemetrexed, and Amivantamab.

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I have lung cancer with a specific EGFR mutation and meet treatment criteria.

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I am fully active or restricted in physically strenuous activity but can do light work.

CHRYSALIS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cycle 1 day 1: predose through eot (30 [+7] days after last dose [cycle 4 day 15]) (each cycle is of 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cycle 1 day 1: predose through eot (30 [+7] days after last dose [cycle 4 day 15]) (each cycle is of 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 day 1: predose through eot (30 [+7] days after last dose [cycle 4 day 15]) (each cycle is of 28 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1: Number of Participants With Dose Limiting Toxicity (DLT)

Part 2: Duration of Response (DOR)

Part 2: Number of Participants With Adverse Events (AEs) and Serious AEs

+2 more

Secondary outcome measures

Accumulation ratio (R) of Amivantamab

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Amivantamab

Area Under the Serum Concentration-Time Curve From t1 to t2 Time (AUC[t1-t2]) of Amivantamab

+10 more

CHRYSALIS Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2:Amivantamab Monotherapy+Combination Dose ExpansionExperimental Treatment2 Interventions

Participants will receive IV infusion of Amivantamab as monotherapy at Phase 2 dose (RP2D) regimen or in combination lazertinib at the recommended Phase 2 combination dose (RP2CD) regimen as determined in Part 1. The purpose of dose expansion is to further evaluate safety, tolerability, pharmacokinetic, and to assess preliminary efficacy in monotherapy and combination therapy cohorts.

Group II: Part 1:Amivantamab Monotherapy+Combination Dose EscalationsExperimental Treatment4 Interventions

The first cohort of participants will receive intravenous (IV) infusions of Amivantamab 140 milligram (mg) as monotherapy. Each subsequent cohort will receive IV infusions of Amivantamab at increased dose level. Dose escalation will continue until maximum tolerated dose is reached or all planned doses are administered. Participants will receive IV infusion of Amivantamab once weekly during cycle 1 and once every 2 weeks during subsequent cycles (duration of each treatment cycle is 28 days). Participants will receive lazertinib and Amivantamab on Cycle 1 Day 1 (C1D1) prior to initiation of Amivantamab (C1D1) at predefined dose levels, based upon observed safety and protocol defined criteria. Lazertinib will be administered daily thereafter, on 28-day Amivantamab treatment cycle. In Chemotherapy Combination Cohort, participants will receive Amivantamab, administered on a 21-day cycle, in combination with standard of care carboplatin and pemetrexed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lazertinib

2021

Completed Phase 2

~770

Carboplatin

2014

Completed Phase 3

~6670

Pemetrexed

2014

Completed Phase 3

~5250

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,383,557 Total Patients Enrolled

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

745 Previous Clinical Trials

3,959,154 Total Patients Enrolled

Media Library

Amivantamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02609776 — Phase 1

Non-Small Cell Lung Cancer Research Study Groups: Part 1:Amivantamab Monotherapy+Combination Dose Escalations, Part 2:Amivantamab Monotherapy+Combination Dose Expansion

Non-Small Cell Lung Cancer Clinical Trial 2023: Amivantamab Highlights & Side Effects. Trial Name: NCT02609776 — Phase 1

Amivantamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02609776 — Phase 1

Frequently Asked Questions

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

How many healthcare facilities within the city limits are actively participating in this research project?

"This medical trial is open to patients at Mayo Clinic in Rochester, Minnesota, Washington University School of Medicine in Saint Louis, Missouri and Chao Family Comprehensive Cancer Center in Orange County. There are also 20 additional enrolment sites available across the nation."

Answered by AI

Is the Food and Drug Administration sanctioning Amivantamab?

"Our team at Power assigned Amivantamab a safety rating of 1 due to the limited data available from its phase one trial, which provides minimal evidence for both efficacy and safety."

Answered by AI

What is the goal of this research endeavor?

"The primary end-point of this trial, measured within a 28 day window, is the Duration of Response (DOR). Secondary objectives include Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) and Maximum Serum Concentration (Cmax) for Amivantamab as well as Time to Reach Maximum Observed Serum Concentration (Tmax) and Cmax for Lazertinib."

Answered by AI

In what capacity is Amivantamab typically employed?

"Amivantamab is capable of treating the early stage development of thymoma, as well as advanced stages of testicular cancer."

Answered by AI

How many participants have volunteered for this clinical trial?

"Affirmative. According to the information displayed on clinicaltrials.gov, this medical trial is enrolling new participants. The original post was made on May 24th 2016 and updated most recently on November 9th 2022; it aims to recruit 780 patients from 20 different centres across the country."

Answered by AI

Are there any other research investigations that involve the use of Amivantamab?

"Amivantamab was initially tested in 2002 at Bristol Royal Hospital for Children, with 1046 trials completed thus far. Currently, Rochester, MN is host to a plethora of active clinical trials involving amivantamab; 770 studies are still ongoing."

Answered by AI

Is enrollment for this medical experiment currently available to participants?

"Affirmative. The clinical trial, which was initially declared on May 24th 2016, is actively recruiting for 780 participants across 20 different medical locations; the latest update to this listing was posted on November 9th 2022."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Amivantamab in EGFR Exon 20 Insertion–mutated Non–small-cell Lung Cancer Progressing on Platinum Chemotherapy: Initial Results from the CHRYSALIS Phase I Study

Park, Keunchil, Eric B. Haura, Natasha B. Leighl, Paul Mitchell, Catherine A. Shu, Nicolas Girard, Santiago Viteri, et al.. 2021. “Amivantamab in EGFR Exon 20 Insertion–mutated Non–small-cell Lung Cancer Progressing on Platinum Chemotherapy: Initial Results from the CHRYSALIS Phase I Study”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.21.00662.

egfrJournal

Amivantamab: Treating <i>egfr</i> Exon 20–mutant Cancers with Bispecific Antibody-mediated Receptor Degradation

Köhler, Jens, and Pasi A. Jänne. 2021. “Amivantamab: Treating egfr Exon 20–mutant Cancers with Bispecific Antibody-mediated Receptor Degradation”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.21.01494.

The Journal of Molecular DiagnosticsJournal

Clinical Validation of Companion Diagnostics for the Selection of Patients with Non–small Cell Lung Cancer Tumors Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutations for Treatment with Amivantamab

Jatkoe, Timothy, Songbai Wang, Justin I. Odegaard, Anne Marie Velasco Roth, Drew Osgood, Gabriela Martinez, Paul Lucas, Joshua C. Curtin, and Jayaprakash Karkera. 2022. “Clinical Validation of Companion Diagnostics for the Selection of Patients with Non–small Cell Lung Cancer Tumors Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutations for Treatment with Amivantamab”. The Journal of Molecular Diagnostics. Elsevier BV. doi:10.1016/j.jmoldx.2022.07.003.

clinicaltrials.govStudy