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

Conditions

• Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Amivantamab IV — DRUG
  Amivantamab will be administered.
• Amivantamab SC — DRUG
  Amivantamab will be administered as SC injection.
• Lazertinib — DRUG
  Lazertinib tablet will be administered orally.
• Doxycycline — DRUG
  Doxycycline tablet will be administered orally.
• Minocycline — DRUG
  Minocycline capsule will be administered orally.
• Clindamycin — DRUG
  Clindamycin lotion will be used as topical application on the scalp.
• Chlorhexidine — DRUG
  Chlorhexidine solution will be used as topical application on hands and feet.
• Noncomedogenic skin moisturizer — OTHER
  Noncomedogenic skin moisturizer will be used as topical application.
• Ruxolitinib — OTHER
  Ruxolitinib will be used to the affected skin area.
• Tacrolimus — OTHER
  Tacrolimus will be used as topical application to the affected skin area.
• Zinc gluconate — DRUG
  Zinc gluconate tablet will be administered.
• Propranolol — DRUG
  Propranolol tablet will be administered.
• Timolol — DRUG
  Timolol will be used to the affected skin area.
• Clobetasol — DRUG
  Clobetasol shampoo will be used on the scalp.

Study Details

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 and with modified enhanced dermatologic 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. The study also includes Expansion cohorts (in 2 different schedules) to evaluate enhanced dermatologic management and early intervention for DAEIs or paronychia, in participants receiving subcutaneous amivantamab and lazertinib. A substudy will enroll participants from Arms A and B who experience specific new-onset or persistent DAEIs (Grade \>=2) during treatment with intravenous (IV) amivantamab and lazertinib. This substudy aims to assess the reactive use of dermatologic treatment strategies in these participants.

Key Dates

Start date

Feb 16, 2024

Status verified

Jun 2026

Primary completion

May 31, 2027

Completion

Jan 31, 2032

Study Design

Enrollment

305 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Enhanced Dermatologic Management
  Participants will receive enhanced dermatologic management to reduce toxicities in skin and nail with doxycycline tablet or minocycline capsule, clindamycin topical lotion, chlorhexidine topical solution, and noncomedogenic skin moisturizer during background anticancer treatment of advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) with amivantamab intravenously (Dose 1 for body weight \[BW\] less than 80 kilograms \[kg\] and Dose 2 for BW greater than or equal to \[\>=\] 80 kg as IV infusion \[Arm A\]) until documented disease progression using Response Evaluation Criteria in Solid Tumors version 1.1).
• Active Comparator: Arm B: Standard-of-Care Dermatologic Management
  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 IV infusion plus lazertinib, dose and dosing schedule as same as experimental arm.
• Experimental: Sub-study: Cohort A: Ruxolitinib
  Participants enrolled in Arms A and B of the main study who experience new-onset or persistent specific DAEIs (Grade greater than or equal to \[\>=\] 2, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] v5.0) will be enrolled and receive reactive treatment with ruxolitinib in the sub-study. Participants in the sub-study will continue to receive amivantamab and lazertinib.
• Experimental: Sub-study: Cohort B: Tacrolimus
  Participants enrolled in Arms A and B of the main study who experience new-onset or persistent specific DAEIs (Grade \>= 2, as defined by NCI-CTCAE v5.0) will be enrolled and receive reactive treatment with tacrolimus in the sub-study. Participants in the sub-study will continue to receive amivantamab and lazertinib.
• Experimental: Amivantamab Subcutaneous (SC) Expansion Cohort: Standard Schedule
  Participants will receive modified enhanced dermatologic management with oral doxycycline or minocycline, zinc gluconate and noncomedogenic skin moisturizer during background anticancer treatment of advanced or metastatic EGFR mutated NSCLC with amivantamab SC and lazertinib as per standard schedule. If a participant develops a dermatologic adverse event of interest (DAEI) they will receive early intervention as follows: for facial (ruxolitinib), for scalp (oral propranolol and clobetasol), for paronychia (chlorhexidine in addition to timolol) until documented disease progression using Response Evaluation Criteria in Solid Tumors version 1.1.
• Experimental: Amivantamab SC Expansion Cohort: Modified Schedule
  Participants will receive modified enhanced dermatologic management with oral doxycycline or minocycline, zinc gluconate and noncomedogenic skin moisturizer during background anticancer treatment of advanced or metastatic EGFR mutated NSCLC with amivantamab SC and lazertinib as per modified schedule. If a participant develops a DAEI they will receive early intervention as follows: for facial (ruxolitinib), for scalp (oral propranolol and clobetasol), for paronychia (chlorhexidine in addition to timolol) until documented disease progression using Response Evaluation Criteria in Solid Tumors version 1.1.

Primary Outcome Measure

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 [ Time Frame: Up to 12 weeks after initiation of anticancer treatment ]

Locations (28)

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