Trastuzumab Deruxtecan for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called trastuzumab deruxtecan for individuals with non-small cell lung cancer (NSCLC). The researchers aim to determine if this drug can shrink tumors before surgery in patients with a specific HER2 gene change in their cancer. They seek participants with surgically removable NSCLC who have been diagnosed with HER2-amplified or HER2-mutated cancer. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor to get specific guidance based on your situation.
Is there any evidence suggesting that trastuzumab deruxtecan is likely to be safe for humans?
Research has shown that trastuzumab deruxtecan is generally well-tolerated, but like many treatments, it can cause side effects. In earlier studies, 46% of patients experienced serious side effects from the drug. The most common issue was a decrease in white blood cells, occurring in 73% of patients. This is significant because white blood cells help fight infections.
Recent trials have not identified any new safety concerns, indicating that the drug's safety aligns with expectations from earlier research. While the drug has shown promise in treating certain cancers, potential participants should be aware of these possible side effects when considering joining a clinical trial.12345Why do researchers think this study treatment might be promising for lung cancer?
Trastuzumab Deruxtecan is unique because it combines a targeted therapy approach with the power of chemotherapy, specifically designed for non-small cell lung cancer (NSCLC). Unlike traditional treatments like chemotherapy alone or other targeted therapies such as EGFR or ALK inhibitors, Trastuzumab Deruxtecan delivers a potent cytotoxic agent directly to cancer cells by targeting the HER2 protein. This dual-action mechanism not only increases the precision of the treatment but also minimizes damage to healthy cells, which is why researchers are excited about its potential to offer improved outcomes for patients with HER2-positive NSCLC.
What evidence suggests that trastuzumab deruxtecan might be an effective treatment for non-small cell lung cancer?
Studies have shown that trastuzumab deruxtecan effectively treats HER2-mutant non-small cell lung cancer (NSCLC). Approximately 55% of patients experienced significant tumor shrinkage. Research also indicates that this treatment can help patients live for about eight months without cancer progression. While side effects are generally manageable, some patients may experience lung inflammation. Overall, the evidence suggests that trastuzumab deruxtecan offers a meaningful benefit for those with HER2-mutant NSCLC.35678
Who Is on the Research Team?
James Isbell, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults (18+) with HER2-amplified or mutated non-small cell lung cancer (NSCLC) at certain stages, whose tumors can be surgically removed. Participants must have good heart and lung function, no recent major surgeries or other cancers, and cannot be pregnant. They must agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive neoadjuvant trastuzumab deruxtecan to assess tumor viability reduction before surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Trastuzumab Deruxtecan
Trial Overview
The study tests trastuzumab deruxtecan given before surgery in people with specific types of NSCLC to see if it shrinks tumors. All participants receive the drug before their planned tumor removal surgery.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants with Stage II, IIIA or IIIB Non-Small Cell Lung Cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
AstraZeneca
Industry Sponsor
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
Citations
Trastuzumab Deruxtecan in HER2-Mutant Non–Small-Cell ...
Trastuzumab deruxtecan showed durable anticancer activity in patients with previously treated HER2-mutant NSCLC. The safety profile included interstitial lung ...
Comparative efficacy of trastuzumab deruxtecan versus ... - PMC
This ITC suggested that T-DXd was associated with a consistent and meaningful benefit in terms of PFS and favorable OS relative to relevant ...
Trastuzumab Deruxtecan for ERBB2-Mutant Metastatic ...
With the T-DXd 6.4-mg/kg dose, systemic confirmed ORRs were 50% and 59% for patients with and without brain metastases, respectively, and the ...
Results in adults receiving their first treatment for mBC
At the time of data analysis (May 2021), median progression-free survival was not yet reached for people receiving ENHERTU. This means that more than half of ...
DESTINY-Lung06 Phase 3 Trial of ENHERTU Initiated as ...
“DESTINY-Lung06 is evaluating a targeted treatment strategy for patients with HER2 overexpressing metastatic non-squamous non-small cell lung ...
Characterization of the safety profile of trastuzumab ... - PMC
Trastuzumab deruxtecan (T-DXd), an approved human epidermal growth factor receptor 2 (HER2)-directed antibody–drug conjugate, may cause treatment-emergent ...
Efficacy Data | ENHERTU® (fam-trastuzumab deruxtecan-nxki)
In this pooled safety population, the most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (73%), ...
DESTINY-Lung04 Phase 3 Trial of ENHERTU® Initiated in ...
DESTINY-Lung04 is a global, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) compared to standard of care.
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