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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

Status
Active
Cancer Type
Lung Cancer
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06120140
Protocol IDs
61186372NSC2007 (primary)
NCI-2023-10662
2023-505863-35-00
61186372NSC2007
Study Sponsor
Janssen Research & Development, LLC

Summary

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.

Eligibility

  1. Have histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC); Is treatment naive and not amenable to curative therapy including surgical resection or (chemo) radiation. Adjuvant or neoadjuvant therapy for Stage I, Stage II or Stage IIIA disease is allowed if last dose administered more than 12 months prior to the development of locally advanced or metastatic disease
  2. 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
  3. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants with a history of symptomatic brain metastases must have had all lesions treated as clinically indicated (that is, no current indication for further definitive local therapy). Any definitive local therapy to brain metastases must have been completed at least 14 days prior to randomization, and the participant can be receiving no greater than 10 milligram (mg) prednisone or equivalent daily for the treatment of intracranial disease
  4. Can have prior or concurrent second malignancy (other than the disease under study)which natural history or treatment is unlikely to interfere with any study endpoints, safety, or the efficacy of the study treatment(s)
  5. Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Treatment Sites in Georgia

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.