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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

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 55 months).

Awards & highlights

TROPION-Lung04 Trial 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.Check my eligibility

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.See study design

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.

TROPION-Lung04 Trial 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.

TROPION-Lung04 Trial 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 55 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 55 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 55 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

Number of participants with DLTs; TEAEs and other safety parameters during the study.

Secondary outcome measures

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

TROPION-Lung04 Trial Design

14Treatment 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 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 VII: Cohort 3Experimental Treatment3 Interventions

Group VIII: 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 IX: Cohort 14Experimental Treatment1 Intervention

Datopotamab deruxtecan (Dato-DXd) + AZD7789 in participants with treatment-naïve NSCLC

Group X: Cohort 13Experimental Treatment1 Intervention

Datopotamab deruxtecan (Dato-DXd) + AZD7789 in participants with CPI acquired resistant NSCLC

Group XI: Cohort 12Experimental Treatment1 Intervention

Datopotamab deruxtecan (Dato-DXd) + AZD7789 in participants with CPI acquired resistant NSCLC

Group XII: Cohort 11Experimental Treatment2 Interventions

Datopotamab deruxtecan (Dato-DXd) + MEDI5752 in participants with treatment-naïve NSCLC

Group XIII: Cohort 10Experimental Treatment3 Interventions

Datopotamab deruxtecan (Dato-DXd) + MEDI5752 + Carboplatin in participants with treatment-naïve NSCLC

Group XIV: 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

~6670

Durvalumab

2017

Completed Phase 2

~3870

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Daiichi SankyoIndustry Sponsor

392 Previous Clinical Trials

416,044 Total Patients Enrolled

AstraZenecaLead Sponsor

4,271 Previous Clinical Trials

288,613,039 Total Patients Enrolled

Daiichi Sankyo, Inc.Industry Sponsor

389 Previous Clinical Trials

419,976 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 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings available for the public to participate in this clinical experiment?

"Affirmative. Clinicaltrials.gov attests that this trial, which was first listed on April 6th 2021, is actively enrolling members into the study. 232 individuals need to be recruited from 19 medical sites in total."

Answered by AI

Are there any existing records of Datopotamab deruxtecan's application in prior clinical trials?

"Presently, there are 1399 active trials for Datopotamab deruxtecan with 409 of them in the third phase. Most of these studies take place at sites Shanghai but 73704 locations around the world also host clinical trials involving Datopotamab deruxtecan."

Answered by AI

What possible dangers could arise from using Datopotamab deruxtecan therapeutically?

"Datopotamab deruxtecan's safety is still in the process of being evaluated, resulting in a rating of 1. This Phase 1 trial has provided some evidence to support its efficacy and limited data supporting safety."

Answered by AI

How extensive is the current participant base for this research?

"To conduct this medical trial, 232 participants must be enrolled that satisfy the pre-determined inclusion criteria. Patients may enroll in the study at Fox Chase Cancer Center or John Theurer Cancer Center in Pennsylvania and New jersey respectively."

Answered by AI

In what geographic areas are participants able to access this clinical trial?

"There are 19 sites participating in this trial, including Fox Chase Cancer Center of Philadelphia and John Theurer Cancer Center at Hackensack University Medical Centre. Additionally, a research site within Chicago is also working on the project."

Answered by AI

What medical conditions has Datopotamab deruxtecan been employed to treat?

"Datopotamab deruxtecan is frequently administered as an initial intervention. Additionally, it can be leveraged to treat a variety of other diseases including advanced thymoma, carcinoma and neuroendocrine cancer."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer

2021. "Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04612751.

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