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Antibody-drug conjugate
Dato-DXd + Pembrolizumab for Advanced Lung Cancer (TROPION-Lung08 Trial)
Phase 3
Recruiting
Research Sponsored by Daiichi Sankyo, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has provided a formalin-fixed tumor tissue sample for the measurement of trophoblast cell surface protein 2 (TROP2) protein expression and for the assessment of other exploratory biomarkers.
Histologically documented NSCLC that meets specific staging and disease criteria.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 53 months
Awards & highlights
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.
Who is the study for?
This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) who haven't had previous systemic treatments. Participants must have high PD-L1 expression, good physical condition, adequate bone marrow function, and no significant heart issues. They should not have certain infections like hepatitis B/C or HIV, severe eye diseases, recent vaccines, autoimmune diseases, other cancers within a set time frame, or untreated brain metastases.Check my eligibility
What is being tested?
The study compares the effectiveness of Dato-DXd combined with pembrolizumab versus pembrolizumab alone in treating NSCLC without specific genetic changes. It aims to determine which treatment works better for this type of lung cancer by randomly assigning participants to one of the two groups.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in various organs and infusion-related reactions. There may also be fatigue, blood disorders that affect how your body fights infection or clots bloods cells together after an injury.
TROPION-Lung08 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have given a tissue sample for TROP2 protein testing.
Select...
My lung cancer has been confirmed by a biopsy and meets certain stage criteria.
Select...
My tumor shows high PD-L1 expression.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer does not have certain genetic changes according to tests.
TROPION-Lung08 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 53 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 53 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Progression-free Survival Based on Blinded Independent Central Review in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Secondary outcome measures
Disease Control Rate by BICR and Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Duration of Response by BICR and Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Number of Participants With Treatment-emergent Adverse Events (TEAE) Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
+7 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
TROPION-Lung08 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab + Datopotamab Deruxtecan (Dato-DXd)Experimental Treatment2 Interventions
Participants will be randomized to receive 200 mg pembrolizumab followed by 6.0mg/kg Dato-DXd.
Group II: PembrolizumbActive Control1 Intervention
Participants will be randomized to receive 200 mg pembrolizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
419,418 Total Patients Enrolled
Daiichi SankyoLead Sponsor
393 Previous Clinical Trials
415,561 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,402 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 30 days.I do not have untreated brain metastases or spinal cord compression.I had radiotherapy less than 4 weeks ago or received high-dose lung radiation in the last 6 months.I am currently on IV medication for an uncontrolled infection.I have given a tissue sample for TROP2 protein testing.I have severe lung problems as determined by my doctor.I have received specific treatments for my non-small cell lung cancer.I have an autoimmune disease.I have received a transplant from another person.I have or had lung inflammation that needed steroids, or it might be present but not confirmed.I do not have serious heart problems.My lung cancer has been confirmed by a biopsy and meets certain stage criteria.My tumor shows high PD-L1 expression.I do not have active or uncontrolled hepatitis B or C.I have received treatment for advanced lung cancer before.My heart pumps well, confirmed by a heart scan within the last month.I have had cancer other than non-small cell lung cancer, but it fits exceptions.I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.I am at least 18 years old or the legal adult age in my country.I have a serious eye condition affecting my cornea.I am fully active or restricted in physically strenuous activity but can do light work.My bone marrow is working well.My HIV infection is not well controlled.Your disease can be measured using a specific type of imaging test.My cancer does not have certain genetic changes according to tests.You have had serious allergic reactions to Dato-DXd or pembrolizumab in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + Datopotamab Deruxtecan (Dato-DXd)
- Group 2: Pembrolizumb
Awards:
This trial has 2 awards, including:- 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.
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 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."
Answered by AI
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, California as the primary sites for data collection."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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