Informations générales (source: ClinicalTrials.gov)
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 (COCOON)
Interventional
Phase 2
Janssen Research & Development, LLC (Voir sur ClinicalTrials)
février 2024
mars 2026
11 octobre 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:38 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hopital Nord - 13915 - Marseille Cedex 20 - France | Contact (sur clinicalTrials) | ||||
| Hopital PASTEUR - 06001 - Nice - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- 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
- 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
- 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
- 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)
- Have an eastern cooperative oncology group (ECOG) performance status of 0 to 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
- 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
- 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
- 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)
- Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
- History of uncontrolled illness, including but not limited to uncontrolled diabetes;
ongoing or active infection (includes infection requiring treatment with
antimicrobial therapy [participants will be required to complete antibiotics 1 week
prior to starting background anticancer treatment] or diagnosed or suspected viral
infection); active bleeding diathesis; impaired oxygenation requiring continuous
oxygen supplementation; refractory nausea and vomiting, chronic gastrointestinal
diseases, inability to swallow the formulated product, or previous significant bowel
resection that would preclude adequate absorption of background anticancer treatment
or doxycycline/minocycline; psychiatric illness, social situation, or any other
circumstances that would limit compliance with study requirements; any
ophthalmologic condition that is clinically unstable; pre-existing skin condition
that would prevent adequate evaluations of dermatologic toxicity, as determined by
the investigator
- Medical history of interstitial lung disease (ILD), including drug-induced ILD or
radiation pneumonitis
- Known allergy, hypersensitivity, or intolerance to the excipients of amivantamab,
lazertinib, or to tetracyclines, doxycycline, minocycline, or their excipients or to
any component of the enhanced dermatologic management
- Participant has received any prior systemic treatment at any time for locally
advanced stage III B/C or metastatic stage IV disease (adjuvant or neoadjuvant
therapy for stage I, II or IIIA disease is allowed if last dose administered more
than 12 months prior to the development of locally advanced or metastatic disease)
- Participant has an active or past medical history of leptomeningeal disease