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Antibody-drug conjugate

Datopotamab Deruxtecan + Immunotherapy for Non-Small Cell Lung Cancer (TROPION-Lung04 Trial)

Phase 1
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant ≥18 years old on the day of signing the ICF (local regulatory requirement to consent should be followed)
Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC, without EGFR or ALK genomic alterations and no known genomic alterations in other actionable driver kinases with approved therapies
Must not have
Clinically severe pulmonary compromise resulting from intercurrent pulmonary illness
Spinal cord compression or clinically active CNS metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time of the final analysis (when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 9 months of follow-up, approximately 60 months).
Awards & highlights

Summary

This trial will study the safety and effectiveness of a new cancer drug combo in people with advanced lung cancer.

Who is the study for?
Adults with advanced or metastatic non-small cell lung cancer (NSCLC) who are either treatment-naïve or have had one prior chemotherapy without immune checkpoint inhibitors. Participants must have good organ function, measurable disease, no severe illnesses, and an ECOG performance status of 0 or 1. Those with certain genetic alterations in NSCLC or a history of other cancers are excluded.
What is being tested?
The trial is testing the combination of Datopotamab deruxtecan (Dato-DXd), a new drug, with immunotherapy agents MEDI5752/AZD2936 and Durvalumab, plus Carboplatin for some groups. It aims to evaluate safety and how well these treatments work together in patients.
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as inflammation in various organs, infusion-related reactions from the drugs being administered intravenously, bone marrow suppression leading to blood disorders, fatigue, digestive issues like nausea or diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years or older and have signed the consent form.
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My advanced lung cancer does not have EGFR or ALK mutations.
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I am willing and able to have a tumor biopsy.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe lung problems due to a recent illness.
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I do not have active brain metastases or spinal cord compression.
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I do not have an infection needing IV drugs.
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I have had lung inflammation treated with steroids.
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I have a serious eye condition affecting my cornea.
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I have had another type of cancer.
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I have serious heart problems that are not under control.
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I have or had an autoimmune or inflammatory disorder.
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I do not have active hepatitis B or C, or uncontrolled HIV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the time of the final analysis (when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 9 months of follow-up, approximately 60 months).
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the time of the final analysis (when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 9 months of follow-up, approximately 60 months). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with DLTs; TEAEs and other safety parameters during the study.
Secondary study objectives
Best percentage change in the Sum of Diameters of measurable tumors
Disease Control Rate as assessed by the investigator per RECIST version 1.1
Duration of Response as assessed by investigator per RECIST version 1.1
+9 more

Trial Design

15Treatment groups
Experimental Treatment
Group I: Cohort 9Experimental Treatment3 Interventions
Datopotamab deruxtecan (Dato-DXd) + MEDI5752 + Carboplatin in participants with treatment-naïve NSCLC
Group II: Cohort 8Experimental Treatment3 Interventions
Datopotamab deruxtecan (Dato-DXd) + AZD2936 + Carboplatin in participants with treatment-naïve NSCLC
Group III: Cohort 7Experimental Treatment3 Interventions
Datopotamab deruxtecan (Dato-DXd) + AZD2936 + Carboplatin in participants with treatment-naïve NSCLC
Group IV: Cohort 6Experimental Treatment2 Interventions
Datopotamab deruxtecan (Dato-DXd) + AZD2936 in participants with treatment-naïve NSCLC
Group V: Cohort 5Experimental Treatment2 Interventions
Datopotamab deruxtecan (Dato-DXd) + AZD2936 in participants with treatment-naïve NSCLC
Group VI: Cohort 4AExperimental Treatment3 Interventions
Datopotamab deruxtecan (Dato-DXd) + Durvalumab + carboplatin in participants with treatment-naïve NSCLC
Group VII: Cohort 4Experimental Treatment3 Interventions
Datopotamab deruxtecan (Dato-DXd) + Durvalumab + Carboplatin in NSCLC participants who are either treatment-naïve or have received only 1 prior line of systemic chemotherapy without concomitant ICI therapy
Group VIII: Cohort 3Experimental Treatment3 Interventions
Datopotamab deruxtecan (Dato-DXd) + Durvalumab + Carboplatin in NSCLC participants who are either treatment-naïve or have received only 1 prior line of systemic chemotherapy without concomitant ICI therapy
Group IX: Cohort 2Experimental Treatment2 Interventions
Datopotamab deruxtecan (Dato-DXd) + Durvalumab in NSCLC participants who are either treatment-naïve or have received only 1 prior line of systemic chemotherapy without concomitant ICI therapy
Group X: Cohort 14Experimental Treatment2 Interventions
Datopotamab deruxtecan (Dato-DXd) + AZD7789 in participants with treatment-naïve NSCLC
Group XI: Cohort 13Experimental Treatment2 Interventions
Datopotamab deruxtecan (Dato-DXd) + AZD7789 in participants with CPI acquired resistant NSCLC
Group XII: Cohort 12Experimental Treatment2 Interventions
Datopotamab deruxtecan (Dato-DXd) + AZD7789 in participants with CPI acquired resistant NSCLC
Group XIII: Cohort 11Experimental Treatment2 Interventions
Datopotamab deruxtecan (Dato-DXd) + MEDI5752 in participants with treatment-naïve NSCLC
Group XIV: Cohort 10Experimental Treatment3 Interventions
Datopotamab deruxtecan (Dato-DXd) + MEDI5752 + Carboplatin in participants with treatment-naïve NSCLC
Group XV: Cohort 1Experimental Treatment2 Interventions
Datopotamab deruxtecan (Dato-DXd) + Durvalumab in NSCLC participants who are either treatment-naïve or have received only 1 prior line of systemic chemotherapy without concomitant ICI therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6120
Durvalumab
2017
Completed Phase 2
~3840

Find a Location

Who is running the clinical trial?

Daiichi SankyoIndustry Sponsor
404 Previous Clinical Trials
447,573 Total Patients Enrolled
AstraZenecaLead Sponsor
4,359 Previous Clinical Trials
288,646,993 Total Patients Enrolled
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
422,301 Total Patients Enrolled

Media Library

Datopotamab deruxtecan (Antibody-drug conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT04612751 — Phase 1
Lung Cancer Research Study Groups: Cohort 4A, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 10, Cohort 3, Cohort 8, Cohort 12, Cohort 9, Cohort 14, Cohort 13, Cohort 1, Cohort 11, Cohort 2
Lung Cancer Clinical Trial 2023: Datopotamab deruxtecan Highlights & Side Effects. Trial Name: NCT04612751 — Phase 1
Datopotamab deruxtecan (Antibody-drug conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04612751 — Phase 1
~101 spots leftby Jan 2026
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