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Alkylating agents
Dato-DXd + Pembrolizumab for Non-Small Cell Lung Cancer
Phase 3
Recruiting
Research Sponsored by Daiichi Sankyo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC.
Has provided a formalin-fixed tumor tissue sample for the measurement of TROP2 protein expression and for the assessment of other exploratory biomarkers.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 57 months
Awards & highlights
Study Summary
This trial tests a new drug combo vs. chemo for lung cancer patients who have not yet received treatment.
Who is the study for?
Adults over 18 with advanced non-squamous NSCLC who haven't had systemic cancer treatment, have specific levels of TROP2 and PD-L1 proteins, no major gene mutations treatable by approved therapies, good performance status, and no significant health issues like uncontrolled heart disease or active infections. Pregnant women and those with certain lung diseases or recent vaccinations are excluded.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Dato-DXd combined with pembrolizumab versus pembrolizumab with pemetrexed and platinum chemo in first-line treatment for advanced NSCLC. It aims to see which combination works better for patients who meet specific biological criteria.See study design
What are the potential side effects?
Potential side effects include reactions at the infusion site, fatigue, nausea, blood cell count changes leading to increased infection risk or bleeding problems. There's also a chance of lung issues like pneumonitis and other organ inflammation due to immune system activation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't received systemic anticancer therapy for my advanced non-squamous NSCLC.
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I have given a tissue sample for cancer protein testing.
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My cancer can be measured by scans.
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My tumor's PD-L1 level is below 50%.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My lung cancer has been confirmed by a lab test and meets certain stage requirements.
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My cancer does not have any genetic changes treatable by approved drugs.
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My cancer does not have specific genetic changes treatable with targeted therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 57 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 57 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Malignant Neoplasms
Malignant Neoplasms
Secondary outcome measures
Disease Control Rate by BICR and Investigator in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Malignant Neoplasms
Malignant Neoplasms
+7 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Dato-DXd + Pembrolizumab + Platinum ChemotherapyExperimental Treatment4 Interventions
Participants will be randomized to receive 6.0mg/kg Dato-DXd plus 200 mg pembrolizumab plus platinum chemotherapy (cisplatin 75 mg/m^2 or carboplatin area under the curve [AUC) 5]).
Group II: Dato-DXd + PembrolizumabExperimental Treatment2 Interventions
Participants will be randomized to receive 6.0mg/kg Dato-DXd plus 200 mg pembrolizumab.
Group III: Pembrolizumab + Pemetrexed + Platinum ChemotherapyActive Control4 Interventions
Participants will be randomized to receive 200 mg pembrolizumab plus 500 mg/m^2 pemetrexed plus platinum chemotherapy (cisplatin 75 mg/m^2 or carboplatin area under the curve [AUC) 5]).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
Daiichi SankyoLead Sponsor
393 Previous Clinical Trials
415,326 Total Patients Enrolled
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
419,183 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,272 Previous Clinical Trials
288,611,700 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, breastfeeding, nor planning to become pregnant.My cancer can be measured by scans.I do not have active or uncontrolled hepatitis B or C.My tumor's PD-L1 level is below 50%.You have other health problems, heart disease, mental health issues, or use drugs or alcohol excessively.I have received an organ or tissue transplant from another person.I am 18 years old or older.I am fully active or restricted in physically strenuous activity but can do light work.I have received treatment for advanced lung cancer before.I have given a tissue sample for cancer protein testing.I haven't received systemic anticancer therapy for my advanced non-squamous NSCLC.I have or had lung inflammation that needed steroids, or it might be present but not confirmed.I do not have serious heart problems.I have severe lung problems due to another lung illness.I have a serious eye condition affecting my cornea.My lung cancer has been confirmed by a lab test and meets certain stage requirements.I have received specific treatments before.I have had cancer other than non-small cell lung cancer, but it falls under exceptions.I have not received a live vaccine in the last 30 days.My HIV infection is not well controlled.I have an autoimmune disease.My cancer does not have any genetic changes treatable by approved drugs.My cancer does not have specific genetic changes treatable with targeted therapy.I had radiotherapy less than 4 weeks ago or received high-dose lung radiation in the last 6 months.I do not have active brain metastases or spinal cord compression.I have an immune system disorder or am on long-term steroids.
Research Study Groups:
This trial has the following groups:- Group 1: Dato-DXd + Pembrolizumab + Platinum Chemotherapy
- Group 2: Dato-DXd + Pembrolizumab
- Group 3: Pembrolizumab + Pemetrexed + Platinum Chemotherapy
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.
Are any new participants being welcomed into this research at present?
"The clinical trial is currently recruiting volunteers, as evidenced by the data hosted on clinicialtrials.gov. This experiment was initially posted on November 1st 2023 and most recently updated on February 3rd of this year."
Answered by AI
How many individuals are currently participating in this research project?
"In order to conduct this study, 975 participants are necessary and must meet the eligibility requirements. Cancer Specialist of North Florida in Jacksonville, FL and American Oncology Partners of Maryland in Bethesda, MD are two locations where these volunteers can take part."
Answered by AI
What are the current venues where this clinical trial is being conducted?
"The experiment is being conducted at Cancer Specialist of North Florida in Jacksonville, American Oncology Partners of Maryland in Bethesda and Astera Cancer Care in East Brunswick. Additionally, there are four other participating medical centres."
Answered by AI
What potential adverse effects might accompany treatment with Dato-DXd, Pembrolizumab, and Platinum Chemotherapy?
"The clinical data available on Dato-DXd + Pembrolizumab + Platinum Chemotherapy suggests that this regimen is a safe option, thus it received an assessment of 3."
Answered by AI
What is the desired outcome of this medical research study?
"This clinical trial, monitored for up to 29 months from randomization until disease progression or death (whichever occurs earlier), is designed to evaluate Overall Survival in Participants With Advanced or Metastatic Non small cell lung cancer (NSCLC). Secondary outcomes include the Duration of Response by BICR and Investigator as defined per RECIST Version 1.1., Progression-free Survival 2, and Time to Deterioration according to the EORTC-QLQ-LC13 module."
Answered by AI
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