Enhanced Dermatological Care for Lung Cancer
(COCOON Trial)
What You Need to Know Before You Apply
What is the purpose of this 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. 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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you must complete any antibiotics at least one week before starting the trial treatment.
Is the combination of Amivantamab and Lazertinib safe for humans?
What makes the drug Amivantamab and Lazertinib unique for lung cancer treatment?
Amivantamab and Lazertinib are unique because they target specific genetic mutations in lung cancer cells, potentially offering a more personalized treatment approach compared to traditional therapies. This combination may provide an alternative for patients who have specific genetic profiles, which can lead to more effective and tailored treatment outcomes.678910
What data supports the effectiveness of the drug Amivantamab, Rybrevant, amivantamab-vmjw, JNJ-61186372, Lazertinib, Lazcluze for lung cancer?
Research shows that the combination of amivantamab and lazertinib is effective in treating non-small cell lung cancer, especially in patients who have relapsed after other treatments. Studies have demonstrated significant tumor reduction and prolonged response times in patients with specific genetic mutations.124511
Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive amivantamab and lazertinib with enhanced or standard dermatologic management to reduce dermatologic adverse events
Sub-study
Participants experiencing Grade >= 2 dermatologic adverse events receive reactive treatment with ruxolitinib or tacrolimus
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Amivantamab
- Lazertinib
Amivantamab is already approved in United States, European Union for the following indications:
- Locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations
- Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations
- Locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations
- Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University