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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.
Must not have
Female who is pregnant or breastfeeding or intends to become pregnant.
Has active or uncontrolled hepatitis B or C infection.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 57 months
Awards & highlights

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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, breastfeeding, nor planning to become pregnant.
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I do not have active or uncontrolled hepatitis B or C.
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I have received an organ or tissue transplant from another person.
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I have received treatment for advanced lung cancer before.
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I have or had lung inflammation that needed steroids, or it might be present but not confirmed.
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I do not have serious heart problems.
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I have severe lung problems due to another lung illness.
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I have a serious eye condition affecting my cornea.
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I have received specific treatments before.
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My HIV infection is not well controlled.
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I have an autoimmune disease.
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I had radiotherapy less than 4 weeks ago or received high-dose lung radiation in the last 6 months.
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I do not have active brain metastases or spinal cord compression.
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I have an immune system disorder or am on long-term steroids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 57 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 57 months for reporting.

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 more

Trial 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
396 Previous Clinical Trials
419,013 Total Patients Enrolled
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
420,490 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,302 Previous Clinical Trials
288,623,624 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05555732 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Dato-DXd + Pembrolizumab + Platinum Chemotherapy, Dato-DXd + Pembrolizumab, Pembrolizumab + Pemetrexed + Platinum Chemotherapy
Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05555732 — Phase 3
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05555732 — Phase 3
~650 spots leftby Aug 2027