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Antibody-drug conjugate
Dato-DXd + Pembrolizumab for Non-Small Cell 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
Histologically documented NSCLC that meets specific staging criteria.
Documented negative test results for specific genomic alterations based on analysis of tumor tissue.
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 53 months
Awards & highlights
No Placebo-Only Group
Pivotal 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.
Eligible Conditions
- Non-Small Cell Lung Cancer
TROPION-Lung08 Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have non-small cell lung cancer that meets certain staging requirements.
Select...
You have test results showing that your tumor does not have specific genetic changes.
Select...
You have given a tissue sample for testing the levels of TROP2 protein and other markers.
Select...
Your tumor has a lot of PD-L1 protein.
Select...
You have a measurable disease that can be seen on local imaging tests.
Select...
Your heart's pumping ability is good, as shown by tests done within 28 days before starting the study.
Select...
You must be in good physical condition with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at screening.
Select...
Your bone marrow is working well enough 7 days before starting the study.
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 2021 Phase 3 trial • 453 Patients • NCT0306677854%
Neutropenia
45%
Anaemia
38%
Nausea
34%
Alopecia
31%
Decreased appetite
29%
Constipation
27%
Fatigue
26%
Thrombocytopenia
22%
Leukopenia
21%
Diarrhoea
20%
Cough
17%
Asthenia
17%
Dyspnoea
16%
Vomiting
14%
Pyrexia
14%
Dizziness
13%
Headache
13%
Arthralgia
13%
Rash
12%
Hypothyroidism
11%
Pruritus
11%
Insomnia
11%
Back pain
10%
Weight decreased
9%
Hyponatraemia
9%
Aspartate aminotransferase increased
8%
Pneumonia
8%
Oedema peripheral
8%
Upper respiratory tract infection
8%
Alanine aminotransferase increased
7%
Febrile neutropenia
7%
Abdominal pain
7%
Blood creatinine increased
7%
Hypokalaemia
6%
Abdominal pain upper
6%
Stomatitis
6%
Dry skin
6%
Erythema
6%
Dysgeusia
5%
Hyperthyroidism
5%
Dyspepsia
5%
Dysphagia
5%
Nasopharyngitis
5%
Blood alkaline phosphatase increased
5%
Pain in extremity
5%
Musculoskeletal chest pain
5%
Musculoskeletal pain
5%
Chest pain
5%
Hypertension
4%
Hypotension
4%
Urinary tract infection
2%
Atrial fibrillation
2%
Death
2%
Acute kidney injury
2%
Pneumonitis
2%
Pulmonary embolism
1%
Hemiparesis
1%
Clostridium difficile colitis
1%
Neutropenic sepsis
1%
Pleural infection
1%
Sepsis
1%
Infusion related reaction
1%
Diabetes mellitus
1%
Aortic aneurysm
1%
Inappropriate antidiuretic hormone secretion
1%
Pneumothorax
1%
Transient ischaemic attack
1%
Gastritis
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab+EP
Placebo+EP
Pembrolizumab Second Course
Awards & Highlights
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.
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 3
~2030
Find a Location
Who is running the clinical trial?
Daiichi Sankyo, Inc.Lead Sponsor
380 Previous Clinical Trials
360,951 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,822 Previous Clinical Trials
5,013,882 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,182 Previous Clinical Trials
289,629,637 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
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, Californiae 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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