Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Infections

Skin and Connective Tissue Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Paronychia

Exanthema

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Anti-Infective Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Dermatologic Agents

Antineoplastic Agents

Chlorhexidine

Doxycycline

Clindamycin

Clindamycin palmitate

Clindamycin phosphate

Chlorhexidine gluconate

Mitogens

Minocycline

Lazertinib

Amivantamab-vmjw

Anti-Infective Agents, Local

Disinfectants

Anti-Bacterial Agents

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Enzyme Inhibitors

Protein Kinase Inhibitors

Antineoplastic Agents, Immunological

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).

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.

Amivantamab will be administered as intravenous (IV) infusion.

Amivantamab

Lazertinib tablet will be administered orally.

Doxycycline tablet will be administered orally.

Minocycline capsule will be administered orally.

Clindamycin lotion will be used as topical application on the scalp.

Chlorhexidine solution will be used as topical application on hands and feet.

Noncomedogenic skin moisturizer will be used as topical application.

Noncomedogenic skin moisturizer

Study Contact

Janssen Research & Development, LLC Clinical Trial

The purpose of this study is to evaluate whether enhanced dermatologic management can reduce incidence of grade greater than or equal to (\>=) 2 dermatologic adverse events of interest (DAEIs) when compared with standard-of-care skin management in participants with locally advanced or metastatic stage IIIB/C-IV epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) treated first-line with amivantamab and lazertinib.

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

A Phase 2, Open-Label, Randomized Trial Evaluating the Impact of Enhanced Versus Standard Dermatologic Management on Selected Dermatologic Adverse Events Among Patients With Locally Advanced or Metastatic EGFR-Mutated NSCLC Treated First-Line With Amivantamab + Lazertinib

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Number of participants with Grade \>= 2 DAEIs within 12 weeks after initiation of anticancer treatment based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 will be reported. DAEIs includes rash, dermatitis acneiform, pruritus, skin fissures, acne, folliculitis, erythema, eczema, rash maculo-papular, skin exfoliation, skin lesion, skin irritation, dermatitis, rash erythematous, rash macular, rash popular, rash pruritic, rash pustular, dermatitis contact, dermatitis exfoliative generalized, drug eruption, dyshidrotic eczema, eczema asteatotic and paronychia. As per NCI CTCAE v 5.0, severity scale ranges from Grade 1 (mild) to Grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, and Grade 5= death related to adverse event.

Number of participants with DAEIs by severity based on NCI CTCAE v 5.0 will be reported.

Number of participants with Grade \>=2 DAEIs within 6 months after initiation of anticancer treatment based on NCI CTCAE v 5.0 will be reported.

Time to first occurrence of Grade \>=2 DAEI will be reported.

Number of participants with paronychia by severity based on NCI CTCAE v 5.0 will be reported.

Number of participants with scalp rash by severity based on NCI CTCAE v 5.0 will be reported.

Change from baseline in skindex symptoms domain score up to 12 months will be reported. The score of quality of life will be assessed using the Skindex-16 questionnaire. Skindex-16 is used for participants to rate skin conditions.

Change from baseline in PGI-S rash up to 12 months will be reported. Participant quality of life will be evaluated using PGI-S Rash. PGI-S is a single-item questionnaire assessing participants disease severity on a 7-point response scale.

Change from baseline in EORTC-QLQ-C30 score up to 12 months will be reported. EORTC-QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies.

Percentage of participants with dose reductions, dose interruptions, and dose discontinuations of anticancer treatment due to DAEIs will be reported.

Relative dose intensity of anticancer treatment will be reported. The relative dose intensity is defined as the ratio of total actually received dose versus total prescribed dose.

Percentage of participants with VTE AEs (pulmonary embolism and deep vein thrombosis) by severity based on NCI CTCAE v 5.0 will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.

Percentage of participants with AEs by severity based on NCI CTCAE v 5.0 will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.

PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death due to any cause, whichever occurs first.

ORR is defined as the percentage of participants who achieve a partial response (PR) or better response using RECIST v1.1 as assessed by the investigator.

DOR will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the RECIST v1.1 response criteria.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT06120140	Carcinoma, Non-...	Amivantamab Lazertinib Doxycycline Minocycline Clindamycin Chlorhexidine Noncomedogenic ...	18 Years -	Janssen Research & Development, LLC
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	NCT06120140	Carcinoma, Non-...	Amivantamab Lazertinib Doxycycline Minocycline Clindamycin Chlorhexidine Noncomedogenic ...	18 Years -	Janssen Research & Development, LLC

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