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Dato-DXd + Pembrolizumab for Non-Small Cell Lung Cancer(TROPION-Lung08 Trial)
TROPION-Lung08 Trial Summary
This trial will compare the effectiveness of a new cancer drug, datopotamab deruxtecan, when used with pembrolizumab versus pembrolizumab alone in patients with advanced lung cancer.
- Non-Small Cell Lung Cancer
TROPION-Lung08 Trial Eligibility Criteria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
TROPION-Lung08 Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Side effects dataFrom 2021 Phase 3 trial • 453 Patients • NCT03066778
Awards & Highlights
TROPION-Lung08 Trial Design
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Who is running the clinical trial?
- You have HIV infection that is not well controlled.You currently have hepatitis B or C that is not under control.You have non-small cell lung cancer that meets certain staging requirements.You have already received treatment for advanced or metastatic non-small cell lung cancer.You have had serious allergic reactions to Dato-DXd or pembrolizumab in the past.You have already been treated for non-small cell lung cancer with certain medications.You have spinal cord compression or untreated cancer that has spread to the central nervous system.You have had another type of cancer, except in certain specific situations.You have a history of lung disease or inflammation that was not caused by an infection, or you currently have lung disease or inflammation that cannot be ruled out by imaging.You have a serious heart condition that is not under control.You have an eye condition that is important for your overall health.You have a known autoimmune disease that is currently active or suspected.You have a condition that weakens your immune system, or you are taking certain medications that lower your body's ability to fight infections.You have had a tissue or solid organ transplant from another person.You have test results showing that your tumor does not have specific genetic changes.You have given a tissue sample for testing the levels of TROP2 protein and other markers.Your tumor has a lot of PD-L1 protein.You have a measurable disease that can be seen on local imaging tests.Your heart's pumping ability is good, as shown by tests done within 28 days before starting the study.You must be in good physical condition with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at screening.Your bone marrow is working well enough 7 days before starting the study.
- Group 1: Pembrolizumab + Datopotamab Deruxtecan (Dato-DXd)
- Group 2: Pembrolizumb
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
What are the goals of this clinical trial?
"The goal of this trial is to evaluate the overall survival rate in patients who are administered Dato-DXd in combination with pembrolizumab, compared to those who only receive pembrolizumab. Secondary outcomes that will be measured include the objective response rate by investigator, duration of response by BICR and investigator, and objective response rate by blinded independent central review."
How many participants are being asked to join this research project?
"In order to complete this clinical trial, 740 patients that meet the specified criteria are required. The sponsor, Merck Sharp & Dohme LLC, has chosen Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire and The Oncology Institute of Hope and Innovation in Whittier, Californiae Oncology Institute of Hope and Innovation in Whittier, California as the primary sites for data collection."
Are we still enrolling people for this test?
"The information available on clinicaltrials.gov does show that this study is actively looking for enrollees. The trial was first posted on March 4th, 2022 and has been updated as recently as October 26th, 2022. They are seeking 740 individuals total from 8 different locations."
How many different sites are responsible for collecting data for this research project?
"There are 8 locations where this study is taking place. Some notable sites include Dartmouth Hitchcock Medical Center, The Oncology Institute of Hope and Innovation, and Johns Hopkins University."
What is the Pembrolizumab FDA approval status?
"Pembrolizumab has been evaluated in multiple Phase 3 clinical trials, meaning that there is both significant efficacy and safety data. Consequently, our team at Power estimates the safety of Pembrolizumab to be a 3 on a scale from 1 to 3."
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