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Monoclonal Antibodies

Enhanced Dermatological Care for 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

Must not have

Medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis

Participant has an active or past medical history of leptomeningeal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

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My tumor has a specific EGFR mutation.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of lung scarring or inflammation.

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I have or had leptomeningeal disease.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Change From Baseline in EuroQol 5 - Dimension (EQ-5D) Patient-reported Outcome (PRO) up to 12 Months (for Amivantamab Subcutaneous Expansion Cohort Only)

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

+15 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A and Subcutaneous (SC) Expansion Cohort: Enhanced Dermatologic ManagementExperimental Treatment7 Interventions

Participants will receive enhanced dermatologic management to reduce toxicities in skin and nail with 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) 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 \[BW\] less than 80 kilograms \[kg\] and 1400 mg for BW greater than or equal to \[\>=\] 80 kg as IV infusion \[Arm A\], once weekly for the first 4 weeks, then once every 2 weeks) and subcutaneously (expansion cohort) (cycle 1: 1600 mg or 2240 mg once weekly based on BW; cycles 2 onwards: 3520 mg or 4640 mg based on BW on Day 1 of each 28-day cycle) with lazertinib (240 mg, tablet, once daily) until documented disease progression using Response Evaluation Criteria in Solid Tumors version 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 administered as intravenous (IV) infusion plus lazertinib, dose and dosing schedule as same as experimental arm.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Chlorhexidine

2013

Completed Phase 4

~9050

Doxycycline

2008

Completed Phase 4

~2650