Your session is about to expire
← Back to Search
Monoclonal Antibodies
Amivantamab + Cetrelimab for Non-Small Cell Lung Cancer (PolyDamas Trial)
Phase 1 & 2
Recruiting
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years 3 months
Awards & highlights
PolyDamas Trial Summary
This trial studies the best dose and effects of a cancer drug combo in people with NSCLC and EGFR mutations.
Who is the study for?
This trial is for adults with advanced non-small cell lung cancer that has worsened after treatment with a specific type of medication called EGFR TKI and chemotherapy. Participants must be in good physical condition, have at least one measurable tumor not treated by radiation, and their cancer must have certain genetic changes known as EGFR exon19del or L858R mutations.Check my eligibility
What is being tested?
The study is testing the combination of two drugs, Amivantamab and Cetrelimab, to find the best dose for Phase 2 trials and to see how well they work together against lung cancer that has specific genetic mutations and has resisted previous treatments.See study design
What are the potential side effects?
Potential side effects from Amivantamab and Cetrelimab may include reactions where the drug enters the body (infusion-related), inflammation in various organs, fatigue, issues affecting skin or nails, muscle or joint pain. The exact side effects will vary between individuals.
PolyDamas Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Number of Participants with Adverse events (AEs) by Severity
Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs)
Phase 2: Objective Response Rate
Secondary outcome measures
Phase 1 and Phase 2: Number of Participants with AEs by Severity
Phase 1 and Phase 2: Number of Participants with Abnormalities in Clinical Laboratory Parameters
Phase 2 : Duration of Response (DoR)
+3 morePolyDamas Trial Design
2Treatment groups
Experimental Treatment
Group I: Phase 2 (Dose Expansion)Experimental Treatment2 Interventions
Participants will receive amivantamab in combination with cetrelimab in Cohorts A and B at the RP2CD determined by the SET in Phase 1. Participants will continue study treatment until disease progression, unacceptable toxicity, or until another criterion for discontinuation of study treatment is met.
Group II: Phase 1 (Combination Dose Selection)Experimental Treatment2 Interventions
Participants will receive amivantamab low dose or high dose intravenous (IV) infusion based on body weight from Cycle 1 Day 1, Day 2, and subsequently Day 8, Day 15, and Day 22 and then every 2 weeks from Cycle 2 in combination with cetrelimab IV infusion from Cycle 1 Day 2 (after the Day 2 infusion of amivantamab). Doses will be escalated or de-escalated based on the dose limiting toxicities (DLTs) and the recommended Phase 2 combination dose (RP2CD) will be determined by the study evaluation team (SET).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetrelimab
2022
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
976 Previous Clinical Trials
6,384,612 Total Patients Enrolled
Janssen Research & Development, LLC Clinical trialStudy DirectorJanssen Research & Development, LLC
9 Previous Clinical Trials
2,219 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune disease that needs steroids or immunosuppressants.I do not have any uncontrolled illnesses that would stop me from following the study's requirements.I have or might have a lung condition not caused by an infection.I had radiotherapy for symptom relief less than 2 weeks ago.I have a tumor that can be measured and hasn't been treated with radiation.I am fully active or can carry out light work.I have or had cancer spread to the lining of my brain or spinal cord.My lung cancer is confirmed to be non-small cell type and has spread.I have NSCLC and my cancer progressed after standard treatments or I couldn't tolerate them.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2 (Dose Expansion)
- Group 2: Phase 1 (Combination Dose Selection)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the enrollment cap for this clinical research project?
"Affirmative. Records on clinicaltrials.gov show that this trial, initially posted on May 18th 2023, is currently enrolling patients. Approximately 20 participants must be recruited from 4 separate medical centres."
Answered by AI
How geographically expansive are the sites of this research endeavor in America?
"Participants of this clinical trial can choose from 4 sites, including Samsung Medical Center in Seoul, University Malaya Medical Centre in Kuala Lumpur, Hospital Umum Sarawak in Kuching and an additional quartet of facilities."
Answered by AI
What aims are being sought through this research?
"This medical trial aims to assess the adverse events (AEs) of participants, as well as their duration of response and progression-free survival. The primary outcome will be evaluated over a period of up two years and three months; severity is graded according to NCI-CTCAE version 5.0's scale ranging from mild to death related, while responses are measured with RECIST v1.1 guidelines."
Answered by AI
Are participants being accepted for this clinical trial at present?
"Affirmative. Clinicaltrials.gov records indicate that the research, originally posted on May 18th 2023, is actively recruiting participants across 4 sites for a total of 20 volunteers."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger