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.
Signed informed consent form
Age ≥18 years
Able to comply with the study protocol, in the investigator's judgment
Pathologically documented NSCLC
NSCLC that is clinically T4 by virtue of mediastinal organ invasion or stage IIIB by virtue of N3 disease
Patients who on initial assessment by treating thoracic surgeon, appear to require a total pneumonectomy to achieve a complete resection are ineligible for study enrollment
Any previous therapy for lung cancer, including chemotherapy, targeted therapy, immunotherapy, or radiotherapy, within 3 years
Previous lung cancer in remission for <3 years, with the exception of minimally invasive adenocarcinoma or incidental typical carcinoid tumors
Single group
Trastuzumab Deruxtecan
DrugTrastuzumab deruxtecan (T-DXd, fam-trastuzumab deruxtecan-nxki) is a novel HER2- targeting antibody-drug conjugate (ADC).
Major Pathologic Response/MPR Rate
Determine the MPR rate to neoadjuvant T-DXd, as assessed by central pathologic review, in patients with resectable stage II-IIIB (T3-4N2) HER2-amplified or HER2-mutated NSCLC. MPR is defined as the presence of ≤10% residual viable tumor in the primary tumor bed after neoadjuvant chemotherap
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Memorial Sloan Kettering Cancer Center
Lead sponsor
AstraZeneca
Collaborator
