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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

No Placebo-Only Group

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 weeks3 visits

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).

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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 4

~3880