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Monoclonal Antibodies

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

Summary

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

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.
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.
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.

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.

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
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

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129
65%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Anorexia
30%
Constipation
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Cough
15%
Abdominal Pain
15%
Back pain
15%
Increased Urinary Frequency
15%
Weight gain
13%
Arthralgia
10%
Dizziness
10%
Anxiety
10%
Bladder infection
10%
Nasal congestion
10%
Vaginal discharge
8%
Colitis
8%
Dry mouth
8%
Dry skin
8%
Fever
8%
Anal pain
8%
Edema limbs
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Small intestinal obstruction
8%
Thromboembolic event
8%
Urinary frequency
8%
Urinary tract pain
5%
Confusion
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Anemia
5%
Ascites
5%
Gastroesophageal reflux disease
5%
Hypomagnesemia
5%
Lymphedema
5%
Memory impairment
5%
Mucositis oral
5%
Pneumonitis
5%
Rash acneiform
5%
Sinus bradycardia
5%
Upper respiratory infection
5%
Urinary urgency
5%
Vaginal hemorrhage
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Alkaline phosphatase increased
3%
Colonic perforation
3%
Dysarthria
3%
Blood bilirubin increased
3%
CPK increased
3%
Creatinine increased
3%
Myositis
3%
Rectal hemorrhage
3%
Hypothyroidism
3%
Left ventricular systolic dysfunction
3%
Lethargy
3%
Muscle weakness left-sided
3%
Myocarditis
3%
Rectal pain
3%
Weight Loss
3%
Fall
3%
Generalized muscle weakness
3%
Hyperglycemia
3%
Hyperkalemia
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Pleural effusion
3%
Skin infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab

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
Durvalumab
2017
Completed Phase 2
~3840
Cisplatin
2013
Completed Phase 3
~2360
Carboplatin
2014
Completed Phase 3
~6120
Pemetrexed
2014
Completed Phase 3
~5550

Find a Location

Who is running the clinical trial?

Daiichi SankyoIndustry Sponsor
401 Previous Clinical Trials
446,816 Total Patients Enrolled
AstraZenecaLead Sponsor
4,352 Previous Clinical Trials
288,646,565 Total Patients Enrolled
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
422,356 Total Patients Enrolled

Media Library

Durvalumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04686305 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Arm 3A: T-DXd and Volrustomig, Arm 3B: T-DXd, Volrustomig and Carboplatin, Arm 4A: T-DXd and Rilvegostomig, Arm 4B T-DXd and Rilvegostomig with Carboplatin, Arm 1A: T-DXd, Durvalumab and Cisplatin, Arm 1B: T-DXd, Durvalumab and Carboplatin, Arm 1C: T-DXd, Durvalumab and Pemetrexed, Arm 1D: T-DXd
Non-Small Cell Lung Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT04686305 — Phase 1
Durvalumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04686305 — Phase 1
~64 spots leftby Dec 2025
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