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New treatment option for Non-Small Cell Lung Cancer
Official title A Study of Trastuzumab Deruxtecan in People With Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT07428044
What this study is testing
What is Trastuzumab Deruxtecan?
Trastuzumab Deruxtecan is an investigational medicine, being studied as a potential treatment for non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must meet the following criteria for study entry: Neoadjuvant Therapy
- Signed informed consent form
- Age ≥18 years
- Able to comply with the study protocol, in the investigator's judgment
- Pathologically documented NSCLC o Stage II, IIIA, or selected IIIB, including T3N2 or T4 (by size criteria, not by mediastinal invasion), NSCLC (on...
You likely can't join if
- 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...
- 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
- History of (noninfectious) ILD or pneumonitis that required steroids or current ILD or pneumonitis or suspected ILD or pneumonitis that cannot be...
- Lung-specific intercurrent clinically significant illnesses including but not limited to any underlying pulmonary disorder (e.g., pulmonary emboli...
See the full eligibility criteria
Who can join
- Patients must meet the following criteria for study entry: Neoadjuvant Therapy
- Signed informed consent form
- Age ≥18 years
- Able to comply with the study protocol, in the investigator's judgment
- Pathologically documented NSCLC o Stage II, IIIA, or selected IIIB, including T3N2 or T4 (by size criteria, not by mediastinal invasion), NSCLC (on the basis of the 8th edition of the AJCC NSCLC staging system)
- Note: Patients may be enrolled on the basis of clinical stage, but documentation of nodal involvement by invasive mediastinal staging (e.g., endobronchial ultrasound or mediastinoscopy) is strongly encouraged
- Molecular testing results on tissue and/or cfDNA from a CLIA-certified laboratory showing presence of a mutation or amplification (defined as ≥ 4 copies) of HER2. (See Appendix C for a list of known activating HER2...
- Molecular testing results used for patient eligibility should be obtained from a recent tumor biopsy (up to 6 months before enrollment). Alternatively, molecular testing results used to determine patient eligibility...
- Measurable disease as defined by RECIST v1.1 (exceptions may be made in cases of PERCIST-measurable disease [e.g., T0N2 cancer otherwise appropriate for induction therapy])
- NSCLC must have a solid or subsolid appearance on CT scan and cannot have a purely ground-glass-opacity appearance. For subsolid lesions, the tumor size (i.e., clinical T stage) should be measured on the basis of the...
- Evaluated by the attending surgeon before study enrollment to verify that the primary tumor and any involved lymph nodes are technically completely resectable and to verify that the patient is medically operable
- Adequate pulmonary function to be eligible for surgical resection with curative intent
- Pulmonary function tests (PFTs) must be performed at screening and before surgery,in accordance with the preoperative calendar of events, and should include lung volumes, spirometry, and diffusion capacity
- Abnormal PFT results may be further evaluated with quantitative ventilation or perfusion scanning or cardiopulmonary exercise testing, at the discretion of the surgeon
- Postoperative percent predicted forced expiratory volume in 1 second and diffusion capacity must be ≥40% and/or preoperative maximal oxygen consumption (VO2 max) must be \>15 mL/kg/min
- It is acceptable to have the screening PFTs performed within 4 months of Cycle 1, Day 1, but they must be repeated before Cycle 1, Day 1, if clinically indicated
- The postinduction and preoperative PFTs must be performed at least 2 weeks after Cycle 2, Day 1
- Echocardiogram demonstrating left ventricular ejection fraction (LVEF) ≥50% within 28 days before enrollment. If clinically indicated, patients with underlying ischemic or valvular heart disease should be evaluated...
- ECOG Performance Status of 0 or 1
- Adequate hematologic and end-organ function, defined by the following laboratory results obtained within 14 days before the first dose of study treatment:
- Absolute neutrophil count ≥1500/uL (granulocyte-colony stimulating factor administration is not allowed within 1 week before Cycle 1, Day 1)
- Platelet count ≥100,000/uL (platelet transfusion is not allowed within 1 week before Cycle 1, Day 1)
- International normalized ratio or prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤1.5 × the upper limit of normal (ULN)
- Hemoglobin ≥9.0 g/dL
- AST and ALT ≤3 × ULN
- Serum bilirubin ≤1.5 × ULN (up to 3 × ULN for patients with Gilbert syndrome)
- Creatinine clearance ≥30 mL/min (as calculated using the Cockcroft-Gault equation)
- Serum albumin ≥2.5 g/dL
- Male and female participants of reproductive or 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 4.5 months...
- Oral
- Intravaginal
- Transdermal o Progestogen-only hormonal contraception associated with inhibition of ovulation:
- Oral
- Injectable
- Implantable
- Intrauterine device
- Intrauterine hormone-releasing system
- Bilateral tubal occlusion
- Vasectomized partner
- Complete sexual abstinence, defined as refraining from heterosexual intercourse during and upon completion of the study and for at least 4.5 months after the last dose of the study drug. Periodic abstinence (calendar...
- Women of nonchildbearing potential, defined as premenopausal women with a documented tubal ligation or hysterectomy, or postmenopausal women, defined as those with 12 months of spontaneous amenorrhea (in questionable...
- Male participants must not freeze or donate sperm starting at screening and throughout the study period and for at least 4.5 months after the final administration of the study drug. Preservation of sperm should be...
- Female participants must not donate or retrieve for their own use ova from the time of randomization or enrollment and throughout the study treatment period and for at least 7 months after the final administration of...
- Participants should be willing and able to comply with protocol visits and procedures Adjuvant Therapy Adjuvant systemic therapy (i.e., platinum-based chemotherapy and/or immunotherapy) may be given to patients at the...
What rules you out
- 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
- History of (noninfectious) ILD or pneumonitis that required steroids or current ILD or pneumonitis or suspected ILD or pneumonitis that cannot be ruled out by imaging at screening
- Lung-specific intercurrent clinically significant illnesses including but not limited to any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months of study enrollment, severe asthma, severe chronic...
- Any autoimmune, connective tissue, or inflammatory disorders (e.g., rheumatoid arthritis, Sjogren's, sarcoidosis) where there is documentation or suspicion of pulmonary involvement, at the time of screening. Full...
- Previous pneumonectomy (complete)
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- Active primary immunodeficiency, known uncontrolled active HIV infection, or active hepatitis B or C infection, such as those with serologic evidence of viral infection within 28 days of Cycle, 1 Day 1. Participants...
- Corrected QT interval prolongation to \>470 msec (women) or \>450 msec (men) on the basis of the average of the screening triplicate 12-lead electrocardiogram (ECG)
- Receipt of live, attenuated vaccine (mRNA and replication-deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days before the first dose of T-DXd. Note: Patients, if enrolled, should not...
- Known allergy or hypersensitivity to the study treatment or any of the study drug excipients
- History of severe hypersensitivity reactions to other monoclonal antibodies
- Substance abuse or any other medical conditions that would increase the safety risk to the participant or interfere with participation of the participant or evaluation of the clinical study,in the opinion of the...
- Major surgical procedure within 28 days before Cycle 1, Day 1
- Malignancies other than the disease under study within 3 years before Cycle 1, Day 1, with the exception of patients with a negligible risk of metastasis or death and with expected curative outcome (such as adequately...
- Treatment with an investigational agent for any condition within 4 weeks before Cycle 1, Day 1 (or within 5 half-lives of the investigational product, whichever is longer)
- Medical history of myocardial infarction, symptomatic congestive heart failure (CHF; New York Heart Association class II-IV), unstable angina, or serious cardiac arrhythmia
- Social, familial, or geographical factors that would interfere with study participation or follow-up
- Concomitant medical condition that would increase the risk of toxicity, in the opinion of the investigator
- Pregnant or lactating or intending to become pregnant during the study o Women of childbearing potential must have a negative serum pregnancy test result within 7 days before initiation of treatment
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States; Rochester, Minnesota, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.