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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up an average of approximately 20 months

Awards & highlights

DL03 Trial 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.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.

DL03 Trial 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.

DL03 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ an average of approximately 20 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~an average of approximately 20 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and an average of approximately 20 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

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%

Constipation

30%

Anorexia

28%

Nausea

28%

Pruritus

25%

Vomiting

20%

Dyspnea

20%

Urinary tract infection

18%

Rash maculo-papular

15%

Back pain

15%

Cough

15%

Abdominal Pain

15%

Weight gain

15%

Increased Urinary Frequency

13%

Arthralgia

10%

Anxiety

10%

Bladder infection

10%

Dizziness

10%

Nasal congestion

10%

Vaginal discharge

Edema limbs

Fever

Anal pain

Dry skin

Colitis

Thromboembolic event

Dry mouth

Flatulence

Headache

Hot flashes

Myalgia

Urinary tract pain

Urinary frequency

Small intestinal obstruction

Anemia

Ascites

Confusion

Pneumonitis

Sinus bradycardia

Renal and urinary disorders - Other, specify

Adrenal insufficiency

Memory impairment

Vaginal hemorrhage

Hypomagnesemia

Upper respiratory infection

Mucositis oral

Rash acneiform

Urinary urgency

Gastroesophageal reflux disease

Lymphedema

Rectal hemorrhage

Colonic perforation

Generalized muscle weakness

Hyperkalemia

Lethargy

Myocarditis

Fall

Skin infection

Hypothyroidism

Muscle weakness left-sided

Alanine aminotransferase increased

Hyperglycemia

Pleural effusion

Creatinine increased

Rectal pain

Aspartate aminotransferase increased

Dysarthria

Myositis

CPK increased

Pain in extremity

Peripheral sensory neuropathy

Alkaline phosphatase increased

Blood bilirubin increased

Left ventricular systolic dysfunction

Weight Loss

100%

80%

60%

40%

20%

Study treatment Arm

Durvalubmab

Durvalubmab + Tremelimumab

DL03 Trial Design

6Treatment groups

Experimental Treatment

Group I: Arm 3B: T-DXd, MEDI5752 and CarboplatinExperimental Treatment3 Interventions

Drug: T-DXd, MEDI5752 and Carboplatin T-DXd: administered as an IV infusion Other Name: DS-8201a, Trastuzumab deruxtecan Biological/Vaccine: MEDI5752 MEDI5752: administered as an IV infusion Other Name: Volrustomig Drug: Carboplatin Carboplatin: administered as an IV infusion

Group II: Arm 3A: T-DXd and MEDI5752Experimental Treatment2 Interventions

Drug: T-DXd and MEDI5752 T-DXd: administered as an IV infusion Other Name: DS-8201a, Trastuzumab deruxtecan Biological/Vaccine: MEDI5752 MEDI5752: administered as an IV infusion Other Name: Volrustomig

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

T-DXd

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

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

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

T-DXd, Durvalumab and Carboplatin

Group VI: 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

~3870

Cisplatin

2013

Completed Phase 3

~1940

Carboplatin

2014

Completed Phase 3

~6670

Pemetrexed

2014

Completed Phase 3

~5250

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Daiichi SankyoIndustry Sponsor

392 Previous Clinical Trials

416,197 Total Patients Enrolled

AstraZenecaLead Sponsor

4,271 Previous Clinical Trials

288,613,192 Total Patients Enrolled

Daiichi Sankyo, Inc.Industry Sponsor

389 Previous Clinical Trials

420,129 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 3B: T-DXd, MEDI5752 and Carboplatin, Arm 3A: T-DXd and MEDI5752, 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

Frequently Asked Questions

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

Has Durvalumab been granted clearance from the Food and Drug Administration?

"Durvalumab's safety rating is only 1, as this trial is placed at the beginning of the process and evidence on its efficacy or security remains limited."

Answered by AI

Are there particular conditions that Durvalumab is employed to ameliorate?

"Durvalumab is usually the first line of treatment for many conditions, including advanced thymoma and testicular cancer. It can also be employed in certain carcinomas and neuroendocrine disorders."

Answered by AI

Is it feasible for me to partake in this investigation?

"This clinical trial is seeking 136 individuals with malignant tumours between 18-120 years of age. Potential applicants must meet the following criteria: Non-squamous non small cell lung cancer that has progressed after 1 or 2 lines systemic therapy, no EGFR mutations, EML4-ALK fusion or other targetable alterations, treatment naïve for locally advanced/metastatic NSCLC in Part 2, HER2+ status as determined by central review of tissue samples according to WHO / ECOG performance standards; measurable disease assessed using RECIST 1.1 and adequate organ and bone marrow function per protocol requirements."

Answered by AI

Is this study actively enrolling participants?

"According to the clinicaltrials.gov registry, this medical trial is actively recruiting participants as of September 15th 2022; it was initially posted on March 9th 2021."

Answered by AI

How many healthcare facilities are participating in the trial?

"Currently, there are 8 medical centres that are facilitating this trial. Locations include Duarte, Bronx and Santa Rosa with other sites spread out across the region. To reduce commute time it is important to choose the closest clinic available if you decide to enrol in the study."

Answered by AI

Could you provide a brief overview of the research examining Durvalumab?

"The initial clinical trial for durvalumab took place at City of Hope Comprehensive Cancer Center in 1997, with 1878 trials having been completed since then. Currently, 1451 live studies are being conducted globally, the majority hailing from Duarte California."

Answered by AI

Are aging individuals above the age of 70 permitted to join this medical research?

"The age range for this particular trial is 18-120, with 143 trials for minors and 3275 specifically designed for seniors."

Answered by AI

How many individuals are enrolled in this experiment?

"Affirmative, clinicaltrials.gov displays that this medical trial is actively recruiting individuals as of today's date. It was initially posted on the 9th of March 2021 and most recently updated on the 15th of September 2022. The research requires 136 participants to be recruited from 8 different sites across America."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC

2021. "Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04686305.

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