Monoclonal Antibodies

T-DXd + Immunotherapy/Chemotherapy for HER2 Positive Lung Cancer (DL03 Trial)

Montreal, Canada

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

HER2overexpression status as determined by central review of tumor tissue

Histologically documented unresectable locally advanced/metastatic non-squamous NSCLC

Must not have

Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms

Medical history of myocardial infarction within 6 months before treatment assignment, symptomatic CHF (New York Heart Association Class II to IV), clinically important cardiac arrhythmias, or a recent (< 6 months) cardiovascular event including stroke

Timeline

Screening 3 weeks

Treatment Varies

Follow Up safety and tolerability (and to determine rp2d) will be assessed for approximately 20 months from informed consent

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether a combination of three drugs is safe and effective in treating patients with HER2 positive lung cancer.

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Who is the study for?

This trial is for adults with advanced HER2+ non-squamous NSCLC who have seen their cancer progress after 1 or 2 treatments. They must be relatively healthy, able to perform daily activities without significant assistance, and not have certain heart conditions, infections like HIV or hepatitis, previous bad reactions to immunotherapy, or specific lung issues.Check my eligibility

What is being tested?

DESTINY-Lung03 is testing the safety of T-DXd combined with immunotherapies (MEDI5752/Durvalumab) and chemotherapy options (Cisplatin/Carboplatin/Pemetrexed). The study will also look at how effective these combinations are in treating patients whose tumors overexpress HER2.See study design

What are the potential side effects?

Possible side effects include allergic reactions to medication components, fatigue, nausea from chemotherapy drugs; immune-related effects such as inflammation in organs due to immunotherapy agents; and potential blood cell count changes leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has high levels of HER2 according to a specialized lab test.

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My lung cancer cannot be removed by surgery and is not squamous type.

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I weigh at least 35 kg.

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My cancer has worsened after 1 or 2 treatments for its advanced stage.

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I have not received any treatment for my advanced lung cancer.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My organs and bone marrow are functioning well.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have active brain metastases needing steroids or seizure meds.

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I haven't had a heart attack, severe heart failure, serious heart rhythm problems, or a stroke in the last 6 months.

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I have never received immunotherapy treatments like anti-PD-1.

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I don't have lasting side effects from cancer treatment above mild level.

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I have or had lung inflammation treated with steroids, or it's suspected but not confirmed by scans.

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I do not have HIV, active hepatitis B or C, or a primary immunodeficiency.

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I know my cancer has a HER2 mutation.

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I have heart issues like severe heart failure, recent heart attack, or irregular heartbeat.

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I do not have an active infection needing strong IV medications.

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I can safely receive platinum-based chemotherapy.

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I have a serious lung condition or had a lung removal surgery.

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I need treatment for fluid buildup in my chest, abdomen, or heart area.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ safety and tolerability (and to determine rp2d) will be assessed for approximately 20 months from informed consent

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~safety and tolerability (and to determine rp2d) will be assessed for approximately 20 months from informed consent

This trial's timeline: 3 weeks for screening, Varies for treatment, and safety and tolerability (and to determine rp2d) will be assessed for approximately 20 months from informed consent for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of AEs and SAEs

Secondary study objectives

Confirmed Objective Response Rate (ORR)

Disease Control Rate (DCR)

Duration of Response (DoR)

+7 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

8Treatment groups

Experimental Treatment

Group I: Arm 4B T-DXd and Rilvegostomig with CarboplatinExperimental Treatment3 Interventions

Drug: T-DXd, Rilvegostomig and Carboplatin T-DXd: administered as an IV infusion Other Name: DS-8201a, Trastuzumab deruxtecan Biological/Vaccine: Rilvegostomig Rilvegostomig: administered as an IV infusion Other Name: Rilvegostomig, AZD2936 Drug: Carboplatin Carboplatin: administered as an IV infusion

Group II: Arm 4A: T-DXd and RilvegostomigExperimental Treatment2 Interventions

T-DXd and Rilvegostomig Drug: T-DXd, Rilvegostomig T-DXd: administered as an IV infusion Other Name: DS-8201a, Trastuzumab deruxtecan Biological/Vaccine: Rilvegostomig Rilvegostomig: administered as an IV infusion Other Name: Rilvegostomig, AZD2936

Group III: Arm 3B: T-DXd, Volrustomig and CarboplatinExperimental Treatment3 Interventions

Drug: T-DXd, Volrustomig and Carboplatin T-DXd: administered as an IV infusion Other Name: DS-8201a, Trastuzumab deruxtecan Biological/Vaccine: Volrustomig Volrustomig: administered as an IV infusion Other Name: Volrustomig Drug: Carboplatin Carboplatin: administered as an IV infusion

Group IV: Arm 3A: T-DXd and VolrustomigExperimental Treatment2 Interventions

Drug: T-DXd and Volrustomig T-DXd: administered as an IV infusion Other Name: DS-8201a, Trastuzumab deruxtecan Biological/Vaccine: Volrustomig Volrustomig: administered as an IV infusion Other Name: Volrustomig

Group V: Arm 1D: T-DXdExperimental Treatment1 Intervention

T-DXd

Group VI: Arm 1C: T-DXd, Durvalumab and PemetrexedExperimental Treatment3 Interventions

T-DXd, Durvalumab and Pemetrexed (Arm not initiated)

Group VII: Arm 1B: T-DXd, Durvalumab and CarboplatinExperimental Treatment3 Interventions

T-DXd, Durvalumab and Carboplatin

Group VIII: Arm 1A: T-DXd, Durvalumab and CisplatinExperimental Treatment3 Interventions

T-DXd, Durvalumab and Cisplatin

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug