← Back to Search

Monoclonal Antibodies

Arm A: Enhanced Dermatologic Management for Non-Small Cell Lung Cancer (COCOON Trial)

Phase 2

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

Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Have a tumor that harbors an epidermal growth factor receptor (EGFR) exon 19del or exon 21 L858R substitution, as detected by an Food and Drug Administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory (sites in the United States) or an accredited local laboratory (sites outside of the United States) in accordance with site standard of care

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

COCOON Trial Summary

"This trial aims to see if better dermatologic care can help lower the occurrence of skin issues in lung cancer patients receiving specific treatment."

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer that hasn't been treated yet and can't be removed by surgery. Participants should have a certain type of mutation in their cancer, be generally well enough to perform daily activities (ECOG 0-1), and could have had brain metastases if treated at least two weeks before the trial. They shouldn't need more than a low dose of steroids for brain symptoms.Check my eligibility

What is being tested?

The study tests whether an enhanced skin care routine reduces skin-related side effects in patients taking Amivantamab and Lazertinib for lung cancer. The enhanced care includes antibiotics like Doxycycline or Minocycline, antiseptic washes, and moisturizers compared to standard skin care practices.See study design

What are the potential side effects?

Possible side effects include rash and paronychia (nail infection) from the main drugs Amivantamab and Lazertinib. Antibiotics may cause stomach upset or allergic reactions, while skin products might lead to irritation or dryness.

COCOON 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 tumor has a specific EGFR mutation.

Select...

My brain metastases have been treated, and I'm on a low dose of steroids or less.

COCOON Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 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

Number of Participants With Grade Greater Than or Equal to (>=) 2 Dermatologic Adverse Events of Interest (DAEIs) Within 12 Weeks After Initiation of Anticancer Treatment

Secondary outcome measures

Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Score up to 12 Months

Change From Baseline in Patient's Global Impression-Severity (PGI-S) Rash up to 12 Months

Change From Baseline in Skindex Symptoms Domain Score up to 12 Months

+12 more

COCOON Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A: Enhanced Dermatologic ManagementExperimental Treatment7 Interventions

Participants will receive enhanced dermatologic management to reduce dermatologic toxicities in skin and nail with oral doxycycline tablet or minocycline capsule (100 milligrams [mg] twice daily for 12 weeks), clindamycin 1 percent (%) topical lotion, chlorhexidine 4% topical solution, and noncomedogenic skin moisturizer (once daily, sufficient quantity to cover skin) during background anticancer treatment of advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) with amivantamab (1050 mg for body weight less than [<] 80 kilograms [kg] and 1400 mg for body weight greater than or equal to [>=] 80 kg as intravenous [IV] infusion, once weekly for the first 4 weeks and then once every 2 weeks) and lazertinib (240 mg, tablet, once daily) until documented disease progression using Response Evaluation Criteria in Solid Tumors [RECIST] version [v] 1.1).

Group II: Arm B: Standard-of-Care Dermatologic ManagementActive Control2 Interventions

Participants will receive standard care for dermatologic management according to local practice to reduce dermatologic toxicities in skin and nail during background anticancer treatment of advanced or metastatic EGFR-mutated NSCLC with amivantamab plus lazertinib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Clindamycin

2017

Completed Phase 4

~14740

Lazertinib

2021

Completed Phase 2

~770

Minocycline

2005

Completed Phase 4

~1000

Chlorhexidine

2013

Completed Phase 4

~9050

Doxycycline

2008

Completed Phase 4

~2430

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

976 Previous Clinical Trials

6,384,392 Total Patients Enrolled

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

746 Previous Clinical Trials

3,959,978 Total Patients Enrolled

Frequently Asked Questions

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

What is the current number of individuals under observation in this clinical investigation?

"A total of 180 eligible patients are needed to enroll in this medical research. Patients meeting the set criteria can partake in the trial at diverse locations, including National Taiwan University Hospital in Taipei, Illinois and Gundersen Health System in W. Salem, New york."

Answered by AI

At how many different sites is this study currently being managed?

"The current patient recruitment phase is ongoing at 7 diverse sites, including Taipei, W. Salem, and Kuching among others. Opting for the nearest location is advised to reduce travel burden upon enrollment."

Answered by AI

What is the level of safety associated with Arm A: Enhanced Dermatologic Management for individuals?

"Based on our evaluation, the safety rating for Arm A: Enhanced Dermatologic Management is 2 as it corresponds to a Phase 2 trial with existing safety data but lacking efficacy evidence."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib

2024. "Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06120140.

All > Non Small Cell Lung Cancer > Paid Studies Seattle