MULTICENTER, OPEN-LABEL EXPANDED ACCESS PROGRAM OF TRASTUZUMAB DERUXTECAN IN SUBJECTS WITH HER2 MUTATED METASTATIC/LOCALLY-ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC)

eno Shizuko0 sites30 target enrollmentJanuary 30, 2023

Overview

Phase: N/A
Intervention: Not specified
Conditions: Not specified
Sponsor: eno Shizuko
Enrollment: 30
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 30, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

eno Shizuko

Eligibility Criteria

Inclusion Criteria

•1\) Must have provided informed consent for study participation before performance of any study\-specific procedure or test.
•2\) Men or women \>\= 18 years old.
•3\) Pathologically documented metastatic/locally advanced NSCLC with a known activating HER2 mutation. The HER2 mutation must be documented from an archival or fresh tumor tissue sample analyzed by laboratory performing testing to Good Laboratory Practice (GLP) standard.
•Note: HER2 mutation documented only from a liquid biopsy sample cannot be used for enrollment.
•4\) Subjects who had previous treatment including platinum therapy in the metastatic/locally advanced setting and not amenable to curative surgery or radiation. The subject must have progressed during or after the last treatment regimen or discontinued because of unacceptable toxicity.
•5\) Has ECOG PS of 0 to 1\.
•6\) Has left ventricular ejection fraction (LVEF) \>\= 50% within 28 days before enrollment.
•7\) Has adequate organ and bone marrow function within 28days before randomization/enrollment. Transfusion (red blood cell or platelet) or granulocyte\-colony stimulating factor (G\-CSF) administration is not allowed within 2 weeks prior to randomization. Organ and bone marrow function criteria must also be met when laboratory tests are repeated within 3 days of randomization/enrollment as appropriate. Adequate organ/bone marrow function
•8\) Has adequate treatment washout period before enrollment
•9\) Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and 4 months for males, after the last dose of study drug.

Exclusion Criteria

•1\) Medical history of myocardial infarction within 6 months before enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV. Subjects with troponin levels above ULN at screening (as defined by the manufacturer), and without any MI related symptoms should have a cardiologic consultation before enrollment to rule out MI.
•2\) Has a corrected QT interval (QTcF) prolongation \> 470 msec (females) or \>450 msec (males) based on average of triplicate12\-lead ECG at screening.
•3\) Has a history of (non\-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
•4\) Has 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. Subjects with clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of brain radiotherapy and study enrollment.
•5\) Has multiple primary malignancies within 3 years, except adequately resected non\-melanoma skin cancer, curatively treated in\-situ disease, or other solid tumors curatively treated.
•6\) Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.
•7\) Has a history of severe hypersensitivity reactions to other monoclonal antibodies.
•8\) Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
•9\) Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results.
•10\) Active primary immunodeficiency, known uncontrolled active HIV infection or active hepatitis B or C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Subjects should be tested for HIV prior to randomization/enrollment if required by local regulations or institutional review board (IRB)/ethics committee (EC).

Outcomes

Primary Outcomes

Not specified

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