← Back to Search

Monoclonal Antibodies

Lazertinib + Amivantamab for Non-Small Cell Lung Cancer (Chrysalis-2 Trial)

Q: What is the cut-off for participation in this trial?

<p>Janssen Research &#x26; Development, LLC will be overseeing this trial from the UCSF Helen Diller Comprehensive in San Francisco and USC - Norris Comprehensive <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center in Los Angeles. To achieve statistical significance within its parameters, a total of 460 compliant individuals must be recruited.</p>

Phase 1

Recruiting

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

Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1

Expansion Cohort A: Participant must have advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) that has progressed on prior treatment with osimertinib in the first or second line, followed by progression on a platinum-based chemotherapy regimen as the last line of therapy prior to study enrollment. Prior use of first or second generation EGFR tyrosine kinase inhibitor (TKI) is allowed if administered prior to osimertinib

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2.5 years

Awards & highlights

Chrysalis-2 Trial Summary

This trial is testing the combination of two drugs, lazertinib and amivantamab, to treat EGFR-mutated non-small cell lung cancer. The first part of the trial is to see if the recommended doses of both drugs are tolerable when used together. The second part is to see if the combination of the two drugs is effective at treating the cancer.

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has specific EGFR mutations. Participants may have had previous treatments like chemotherapy or EGFR inhibitors, but must not have uncontrolled illnesses, active infections, severe gastrointestinal issues, or untreated brain metastases. They should be able to swallow pills and comply with study requirements.Check my eligibility

What is being tested?

The trial is testing Lazertinib alone or combined with Amivantamab in NSCLC patients. It aims to find the safest dose when used together and assess how well they work against tumors with certain EGFR mutations. Some will also receive standard chemotherapy drugs Carboplatin and Pemetrexed.See study design

What are the potential side effects?

Possible side effects include reactions at the infusion site, fatigue, nausea, diarrhea, skin rash and potential increase in liver enzymes. There's a risk of developing serious conditions such as interstitial lung disease from Lazertinib and infusion-related reactions from Amivantamab.

Chrysalis-2 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

My advanced lung cancer has worsened after specific treatments.

Select...

My advanced lung cancer has worsened after treatment with osimertinib.

Chrysalis-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Clinical Benefit Rate (CBR) Among Participants with MET3+ Staining on >=25% of Tumor Cells (Phase 1b Expansion Cohorts E and F)

Duration of Response (DOR) Among Participants with MET3+ Staining on >=25% of Tumor Cells (Phase 1b Expansion Cohorts E and F)

Number of Participants with AEs as a Measure of Safety and Tolerability (Phase 1b combination LACP)

+7 more

Secondary outcome measures

CBR (Phase 1b expansion Cohorts E and F)

Clinical Benefit Rate (CBR) (Phase 1b expansion)

DOR (Phase 1b Expansion Cohorts E and F)

+12 more

Side effects data

From 2022 Phase 1 & 2 trial • 29 Patients • NCT04075396

47%

Anaemia

47%

Diarrhoea

27%

Dyspnoea

27%

Nausea

27%

Aspartate Aminotransferase Increased

27%

Rash

20%

Hyperkalaemia

20%

Blood Alkaline Phosphatase Increased

20%

Dizziness

20%

Neutrophil Count Decreased

20%

Asthenia

20%

Alanine Aminotransferase Increased

20%

Hyponatraemia

20%

Oedema Peripheral

20%

Pain in Extremity

20%

Back Pain

20%

Paronychia

13%

Pain

13%

Decreased Appetite

13%

Hypercholesterolaemia

13%

Neutropenia

13%

Pulmonary Embolism

13%

Abdominal Pain Upper

13%

Vomiting

13%

Blood Creatinine Increased

13%

Hypermagnesaemia

13%

Paraesthesia

13%

Cough

13%

Hypercalcaemia

13%

Muscular Weakness

13%

Arthralgia

Cancer Pain

Medical Device Pain

Bronchitis

Bone Pain

Chest Pain

Onychoclasis

Dysphagia

Deep Vein Thrombosis

Dry Mouth

Neurotoxicity

Benign Prostatic Hyperplasia

Dyspepsia

Appetite Disorder

Angina Pectoris

Vertigo Positional

Musculoskeletal Chest Pain

Adrenalectomy

Vision Blurred

Covid-19

Hordeolum

Pathological Fracture

Leukopenia

Gingival Pain

Abdominal Pain

Cerebrovascular Accident

Onychomadesis

Lymphopenia

Pneumonia

Thrombocytopenia

Constipation

Disorientation

Fatigue

White Blood Cell Count Decreased

Induration

Gait Disturbance

Polydipsia

Headache

Tremor

Folliculitis

Skin Lesion

Weight Decreased

Conjunctivitis

Blood Magnesium Decreased

Troponin I Increased

Dysarthria

Pleural Effusion

Blood Sodium Decreased

Chromaturia

Skin Hyperpigmentation

Pruritus

Blood Bilirubin Increased

Rash Maculo-Papular

Dermatitis Acneiform

Troponin Increased

Polyuria

Rash Macular

Peripheral Sensory Neuropathy

Sciatica

Dysuria

Confusional State

Epistaxis

Solar Dermatitis

100%

80%

60%

40%

20%

Study treatment Arm

Lazertinib 240 mg

Lazertinib 320 mg

Chrysalis-2 Trial Design

9Treatment groups

Experimental Treatment

Group I: Phase 1b (expansion) Cohort F: Amivantamab MonotherapyExperimental Treatment1 Intervention

Participants will receive Amivantamab monotherapy once weekly (QW) for 4 weeks, then every 2 weeks thereafter. Cohort F will seek to validate the IHC-based biomarker strategy, previously identified in Cohort D, by characterizing the activity of JNJ-61186372 monotherapy (Cohort F) in biomarker-positive participants with osimertinib-relapsed, but chemotherapy-naïve, EGFR Exon19del or L858R mutated NSCLC.

Group II: Phase 1b (expansion) Cohort E: Lazertinib and AmivantamabExperimental Treatment2 Interventions

Participants will receive at the RP2CD of Lazertinib orally QD and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter. Cohort E will seek to validate the immunohistochemical (IHC)-based biomarker strategy, by characterizing the activity of Amivantamab and Lazertinib combination in biomarker-positive participants with osimertinib-relapsed, but chemotherapy-naïve, EGFR Exon19del or L858R mutated NSCLC. In addition, Cohort E will seek to collect prospective data to confirm that prophylactic anticoagulation safely and effectively decreases the incidence of VTE events for patients treated with the combination of Amivantamab and Lazertinib, using Cohort F as reference.

Group III: Phase 1b (expansion) Cohort D: Lazertinib and AmivantamabExperimental Treatment2 Interventions

Cohort D will seek to validate one or both potential biomarker strategies (next generation sequencing [NGS] and Immunohistochemical [IHC]), previously identified in Cohort E of Study 61186372EDI1001, in participants with osimertinib-relapsed, but chemotherapy-naive, EGFR Exon19del or L858R mutated NSCLC. Participants will receive at the RP2CD of Lazertinib orally QD and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter.

Group IV: Phase 1b (expansion) Cohort C: Lazertinib and AmivantamabExperimental Treatment2 Interventions

This Cohort C will further characterize the safety, tolerability and preliminary antitumor activity of Lazertinib and JNJ-61186372 combination in participants with uncommon EGFR mutations. Participants will receive at the RP2CD of Lazertinib orally QD and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter.

Group V: Phase 1b (expansion) Cohort B: Lazertinib and AmivantamabExperimental Treatment2 Interventions

This Cohort B will further characterize the safety, tolerability and preliminary antitumor activity of Lazertinib and JNJ-61186372 combination in participants previously treated with advanced or metastatic NSCLC with documented primary EGFR Exon 20ins activating mutation. Participants will receive at the RP2CD of Lazertinib orally QD and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter.

Group VI: Phase 1b (expansion) Cohort A: Lazertinib and AmivantamabExperimental Treatment2 Interventions

This cohort A will further characterize the safety, tolerability, and preliminary antitumor activity of Lazertinib and Amivantamab based combinations within specific NSCLC population "who have progressed after osimertinib and subsequent platinum-based chemotherapy, and platinum-based chemotherapy regimen as the last line of therapy prior to study enrollment. Prior use of first or second generation EGFR TKI is allowed if administered prior to osimertinib. Participants will receive at the RP2CD of Lazertinib orally QD and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter.

Group VII: Phase 1b (combination): Lazertinib, Amivantamab and Platinum-doublet Chemotherapy (LACP)Experimental Treatment4 Interventions

Participants will receive Lazertinib starting dose administered orally once daily (QD) in combination with Amivantamab, and doses of platinum-based chemotherapy (carboplatin and pemetrexed) per standard of care according to local guidance in a 21-day cycle for 4 cycles followed by maintenance with Lazertinib, Amivantamab and pemetrexed until disease progression or unacceptable toxicities.

Group VIII: Phase 1b (combination): Lazertinib and AmivantamabExperimental Treatment2 Interventions

Participants will receive Lazertinib and Amivantamab, after the safety of RP2D of Lazertinib is confirmed in the Phase 1, in 28-day cycles until documented evidence of disease progression, unacceptable toxicity, noncompliance, or withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first. This phase will start enrolling participants after the safety of Amivantamab is confirmed in Japanese participants in Study 61186372EDI1001 (NCT02609776).

Group IX: Phase 1 (monotherapy dose escalation): LazertinibExperimental Treatment1 Intervention

Participants will receive Lazertinib monotherapy orally once daily (QD) in 21-day cycles until documented evidence of disease progression, unacceptable toxicity, noncompliance, or withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first. The subsequent doses of Lazertinib will be assigned by the Study Evaluation Team (SET) according to the dose escalation strategy by Bayesian logistic regression model (BLRM).

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,383,848 Total Patients Enrolled

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

745 Previous Clinical Trials

3,959,445 Total Patients Enrolled

Media Library

Amivantamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04077463 — Phase 1

Non-Small Cell Lung Cancer Research Study Groups: Phase 1b (expansion) Cohort B: Lazertinib and Amivantamab, Phase 1b (expansion) Cohort F: Amivantamab Monotherapy, Phase 1b (expansion) Cohort E: Lazertinib and Amivantamab, Phase 1b (expansion) Cohort D: Lazertinib and Amivantamab, Phase 1b (expansion) Cohort A: Lazertinib and Amivantamab, Phase 1 (monotherapy dose escalation): Lazertinib, Phase 1b (expansion) Cohort C: Lazertinib and Amivantamab, Phase 1b (combination): Lazertinib and Amivantamab, Phase 1b (combination): Lazertinib, Amivantamab and Platinum-doublet Chemotherapy (LACP)

Non-Small Cell Lung Cancer Clinical Trial 2023: Amivantamab Highlights & Side Effects. Trial Name: NCT04077463 — Phase 1

Amivantamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04077463 — Phase 1

Frequently Asked Questions

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

What potential harms are associated with Lazertinib use?

"Limited data exists to support the safety and efficacy of Lazertinib, leading our team at Power to rate its potential side-effects as a 1 on a 3 point scale."

Answered by AI

Are there any prior records of Lazertinib being tested in the laboratory setting?

"Lazertinib was first investigated in 2002 at Bristol Royal Hospital for Children, with 1046 completed clinical trials since then. Currently there are 770 active studies taking place worldwide, the most prevalent being around San Francisco, California."

Answered by AI

What maladies is Lazertinib most efficacious in addressing?

"Lazertinib is commonly prescribed for the initial treatment of various cancers, comprising advanced thymoma, carcinoma neuroendocrine and testicular cancer."

Answered by AI

What is the cut-off for participation in this trial?

"Janssen Research & Development, LLC will be overseeing this trial from the UCSF Helen Diller Comprehensive in San Francisco and USC - Norris Comprehensive Cancer Center in Los Angeles. To achieve statistical significance within its parameters, a total of 460 compliant individuals must be recruited."

Answered by AI

How many institutions are conducting this investigation?

"As of now, 19 clinical sites are accepting patients for this trial. This includes the UCSF Helen Diller Comprehensive in San Francisco, USC - Norris Comprehensive Cancer Center in Los Angeles, and Providence Portland Medical Center in Portland. Additional enrolment locations can be found elsewhere on the list provided."

Answered by AI

Are any vacancies currently available for this clinical trial?

"The research study, which was originally published on September 4th 2019, is currently recruiting participants as per the details found on clinicaltrials.gov. The information was last updated in November 9th 2022."

Answered by AI

What is the primary aim of this research project?

"This clinical trial aims to measure the safety and tolerance of participants over two years, with particular emphasis on adverse events. Secondary endpoints include plasma concentration of Lazertinib, progression-free survival rate, as well as further assessment into AEs caused by the pharmaceutical/biological agent under study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer

2019. "A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04077463.

All > Non Small Cell Lung Cancer