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Monoclonal Antibodies
Patritumab Deruxtecan for Non-Small Cell Lung Cancer
Phase 2
Waitlist Available
Research Sponsored by Daiichi Sankyo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Systemic therapy with at least 1 platinum-based chemotherapy regimen
Has adequate bone marrow reserve and organ function based on local laboratory data within 14 days prior to Cycle 1 Day 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up death date is collected until the participant discontinues the study or up to approximately 45 months
Awards & highlights
Study Summary
This trial will test a new drug to treat lung cancer that has spread or returned after other treatments have been tried.
Who is the study for?
This trial is for adults with advanced non-small cell lung cancer that has an EGFR mutation and has worsened despite previous treatments including an EGFR TKI and platinum-based chemotherapy. Participants must have good performance status, adequate organ function, no severe respiratory issues or uncontrolled diseases, and not be on high-dose steroids or immunosuppressants.Check my eligibility
What is being tested?
The study tests patritumab deruxtecan's effectiveness in two forms: a fixed dose and an up-titration method. It targets patients whose cancer progressed after at least one prior treatment regimen. The drug aims to inhibit tumor growth by targeting the HER3 protein present in some lung cancers.See study design
What are the potential side effects?
Potential side effects of patritumab deruxtecan may include reactions related to infusion, fatigue, nausea, hair loss (alopecia), blood disorders like low platelet count or white blood cells leading to increased infection risk, as well as possible lung problems such as interstitial lung disease.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been treated with a platinum-based chemotherapy.
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My recent tests show my organs and bone marrow are working well.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My cancer has worsened despite the latest treatment.
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My cancer has a specific EGFR mutation.
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My lung cancer cannot be cured with surgery or radiation.
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I agree to provide the necessary tumor tissue for testing.
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I have at least one tumor that can be measured for its size.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ death date is collected until the participant discontinues the study or up to approximately 45 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~death date is collected until the participant discontinues the study or up to approximately 45 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)
Secondary outcome measures
Best Percentage Change in the Sum of Diameters (SoD) of Measurable Tumors
Disease Control Rate (DCR)
Duration of Response (DoR)
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Study Group 2: Patritumab deruxtecan Up-TitrationExperimental Treatment1 Intervention
Study Group 2 will be participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation randomized to receive patritumab deruxtecan up-titration IV every 3 weeks (Q3W)
Group II: Study Group 1: Patritumab deruxtecan 5.6 mg/kgExperimental Treatment1 Intervention
Study Group 1 will be participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation randomized to receive patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)
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Who is running the clinical trial?
Daiichi SankyoLead Sponsor
392 Previous Clinical Trials
411,088 Total Patients Enrolled
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
415,020 Total Patients Enrolled
Daiichi Sankyo Co., Ltd.Industry Sponsor
115 Previous Clinical Trials
48,809 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had enough time between my last treatment and the start of this trial.My cancer diagnosis includes small cell lung cancer, based on previous tissue tests.I have been treated with a platinum-based chemotherapy.My recent tests show my organs and bone marrow are working well.I am 18 years old or older.I haven't had any other cancer besides this one in the last 3 years.I am fully active or can carry out light work.I am taking more than 10 mg of prednisone or similar medication daily.I have active cancer spread to my brain or spinal cord.My cancer has worsened despite the latest treatment.I still have side effects from cancer treatment that haven't improved.My cancer has a specific EGFR mutation.I do not have cancer spread to the lining of my brain and spinal cord.I have or might have a lung condition like pulmonary fibrosis.I do not have major heart problems before starting the treatment.My lung cancer cannot be cured with surgery or radiation.You have HIV infection.You have an active hepatitis B or hepatitis C infection.I agree to provide the necessary tumor tissue for testing.I have severe breathing problems due to lung illness.I have been treated with HER3 antibody or topoisomerase I inhibitor.I have at least one tumor that can be measured for its size.
Research Study Groups:
This trial has the following groups:- Group 1: Study Group 1: Patritumab deruxtecan 5.6 mg/kg
- Group 2: Study Group 2: Patritumab deruxtecan Up-Titration
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.
Has the FDA sanctioned Patritumab Deruxtecan (Up-Titration) for public use?
"Our experts at Power assigned a rating of 2 to the safety profile of Patritumab Deruxtecan (Up-Titration). This is based on its Phase 2 status, indicating that data exists in support of its security but not yet for efficacy."
Answered by AI
What is the current sample size of this research project?
"In order to achieve the desired results, this study requires 420 people who meet its inclusion criteria. Potential participants may enroll at either University of Kansas in Kansas City or Ohio State University Comprehensive Cancer Center in Columbus."
Answered by AI
Are there opportunities for enrolment in this experiment currently?
"Affirmative. Clinicaltrials.gov has verified that this research protocol, which was initially uploaded on February 2nd 2021, is actively searching for participants. 420 individuals are needed to be recruited from 6 different locations."
Answered by AI
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