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Monoclonal Antibodies
Amivantamab + Chemotherapy for Non-Small Cell Lung Cancer (PAPILLON Trial)
Phase 3
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study
Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights
PAPILLON Trial Summary
This trial will compare how effective amivantamab is at treating NSCLC with EGFR Exon 20ins mutations, compared to chemotherapy alone. The metric for success is progression-free survival (PFS).
Who is the study for?
This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has a specific mutation called EGFR Exon 20 insertion. They must have measurable disease, be in good physical condition (ECOG status 0 or 1), and agree to genetic tests of their tumor. Women who can have children must test negative for pregnancy.Check my eligibility
What is being tested?
The study is testing the effectiveness of Amivantamab combined with Carboplatin-Pemetrexed chemotherapy versus just the chemotherapy alone. The main goal is to see which treatment stops the cancer from progressing longer.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, nausea, low blood counts increasing infection risk, potential lung problems like pneumonitis or ILD, and allergic reactions to components of the therapy.
PAPILLON Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman who can have children, have tested negative for pregnancy, and agree to ongoing pregnancy tests.
Select...
My lung cancer is advanced, not squamous, and has a specific EGFR mutation.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
PAPILLON Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-Free Survival (PFS) According to RECIST v1.1 as Assessed by Blinded Independent Central Review (BICR)
Secondary outcome measures
Duration of Response (DoR)
European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
Incidence and Severity of Adverse Events (AEs)
+11 morePAPILLON Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B: Chemotherapy AloneExperimental Treatment2 Interventions
Participants will receive pemetrexed 500 mg/m^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin for up to 4 cycles, and then as maintenance monotherapy until disease progression. Carboplatin AUC 5 IV infusion will be administered on Day 1 of each 21-day cycle for up to 4 cycles. Following the primary analysis for efficacy, the study will transition to an OLE phase and participants will either continue to receive the chemotherapy or cross over to amivantamab in OLE phase. Participants who completed OLE period will enter LTE period and continue to receive same treatment.
Group II: Arm A: Amivantamab + ChemotherapyExperimental Treatment3 Interventions
Participants will receive pemetrexed 500 milligram per meter square (mg/m^2) intravenous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin for up to 4 cycles, and then as maintenance monotherapy until disease progression. Carboplatin area under the concentration-time curve 5 milligram per milliliter (mg/mL) per minute (AUC 5) will be administered as IV infusion on Day 1 of each 21 day cycle, for up to 4 cycles. Participants will receive amivantamab 1400 mg (1750 mg if body weight is >=80 kilogram [kg]) by IV infusion once weekly up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is >=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3. Following the primary analysis for efficacy, the study will transition to an OLE phase and participants will continue to receive the amivantamab plus chemotherapy in OLE phase. Participants who completed OLE period will enter LTE period and continue to receive same treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Pemetrexed
2014
Completed Phase 3
~5250
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,000 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,597 Total Patients Enrolled
Media Library
Non-Small Cell Lung Cancer Patient Testimony for trial: Trial Name: NCT04538664 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any slots open for this research project?
"That is correct. The listing on clinicaltrials.gov currently includes this trial, which was first posted on October 13th 2020 and last updated November 9th 2020. They are seeking 300 participants total, across 18 different sites."
Answered by AI
How many total patients are being included in this experiment?
"To move forward, this clinical trial needs 300 patients that meet the pre-specified inclusion criteria. Luckily, patients can enroll at Texas Oncology Pa in Tyler, Texas or Pacific Shores Medical Group in Long Beach, California."
Answered by AI
Has Amivantamab been used in other research trials before?
"Amivantamab was first researched in 2002 at Edinburgh Royal Hospital for Sick Children. In the last two decades, there have been 1037 completed clinical trials. As of now, 800 are recruiting patients with a significant portion being based in Tyler, Texas."
Answered by AI
Are there any other continents where this research study is taking place?
"Currently, this trial is enrolling patients in Tyler, Texas at Texas Oncology Pa, Long Beach, California at Pacific Shores Medical Group, Orange, Georgia at University of California, Irvine, and 18 other locations."
Answered by AI
What are some potential side effects of Amivantamab?
"Amivantamab's safety has been well-documented in Phase 3 clinical trials, and it has been shown to be effective in multiple rounds of testing. Therefore, we believe it to be a safe medication."
Answered by AI
What are the off-label benefits of Amivantamab?
"Amivantamab is often the first intervention doctors recommend to patients. It is also an effective treatment for advanced thymoma, advanced testicular cancer, and carcinoma, neuroendocrine."
Answered by AI
Who else is applying?
What state do they live in?
Colorado
New York
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Georgetown University Hospital
Langone Health at NYC University, NYU School of Medicine
How many prior treatments have patients received?
0
2
Why did patients apply to this trial?
I did not try any medication. I am allergic to many meds. I have allergic asthma. I can be only a control group. I use Spiriva to improve my breathing and some herbal supplement to support imine and the respiratory system. I have also follicular Lymphoma, which I get after covid Vacination.
PatientReceived 1 prior treatment
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