Trastuzumab Deruxtecan for Lung Cancer

Recruiting at 9 trial locations

Overseen By James Isbell, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Steroids, Chemotherapy, Immunotherapy, others

Disqualifiers: Lung cancer therapy, ILD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: up to 1 year

14 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to find out how many people with HER2-amplified or HER2-mutated non-small cell lung cancer (NSCLC) experience a decrease in tumor viability when they receive trastuzumab deruxtecan before routine surgery to remove tumors.

Who Is on the Research Team?

James Isbell, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Measurable disease as defined by RECIST v1.1

NSCLC must have a solid or subsolid appearance on CT scan

Signed informed consent form

Exclusion Criteria

Substance abuse or medical conditions increasing safety risk or interfering with study participation

Known allergy or hypersensitivity to the study treatment or any of the study drug excipients

I have had lung inflammation or interstitial lung disease before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neoadjuvant trastuzumab deruxtecan to assess tumor viability reduction before surgery

up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Trastuzumab Deruxtecan

How Is the Trial Designed?

Group I: Participants with Non-Small Cell Lung Cancer Experimental Treatment 1 Intervention

Participants with Stage II, IIIA or IIIB Non-Small Cell Lung Cancer

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology