I-DXd in Patients With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
- Conditions
- Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC)MedDRA version: 21.1Level: PTClassification code: 10041068Term: Small cell lung cancer extensive stage Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-512368-79-00
- Lead Sponsor
- Daiichi Sankyo Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 191
Sign and date the ICF prior to the start of any study- specific qualification procedures, Required baseline local laboratory data (within 7 days prior to Cycle 1 Day 1): a. ALT and AST: - =3 × ULN in subjects with no liver metastasis or - =5.0 × ULN in subjects with liver metastasis b. Total bilirubin =1.5 × ULN if no liver metastases or =3 × ULN in the presence of documented Gilbert's syndrome (undocumented hyperbilirubinemia) or liver metastases at baseline c. ANC =1.5 × 109/L (hematopoietic growth factors [eg, G-CSF, GM-CSF] support allowed up to 14 days before screening laboratory tests) d. Platelet count =100 × 109/L (platelet transfusion is allowed up to 14 days before screening laboratory tests) e.Hemoglobin =8.5 g/dL (transfusion and/or growth factor support allowed up to 14 days before screening laboratory tests) f. Creatinine clearance =30 mL/min, as calculated using the CockcroftGault equation g. International normalized ratio (INR)/prothrombin time (PT) and either partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) =1.5 × ULN, except for subjects receiving anti vitamin K derivative anticoagulant therapy who must have prothrombin time international normalization ratio within the therapeutic range as deemed appropriate by the investigator., If the subject is a female of childbearing potential, she must have a negative serum pregnancy test within 7 days before the first dose of study drug and must be willing to use a highly effective birth control upon enrollment, during the Treatment Period, and for 7 months following the last dose of study drug. A female is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months) unless permanently sterile (undergone a hysterectomy, bilateral salpingectomy or bilateral oophorectomy) with surgery at least 1 month before the first dose or confirmed by FSH test., If male, the subject must be surgically sterile or willing to use highly effective birth control upon enrollment, during the Treatment Period, and for 4 months following the last dose of study drug., Male subjects must not freeze or donate sperm starting at enrollment, throughout the Treatment Period, and for at least 4 months following the last dose of the study drug. Preservation of sperm may be considered prior to enrollment in this study., Female subjects must not donate, or retrieve for their own use, ova from the time of enrollment and throughout the Treatment Period, and for at least 7 months following the last dose of the study drug. They should refrain from breastfeeding throughout this time. Preservation of ova may be considered prior to enrollment in this study., Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions., Subject must have at least one lesion, not previously irradiated, amenable to core biopsy and must consent to provide a pretreatment biopsy tissue sample and on-treatment biopsy. Fresh pretreatment biopsy may be waived for subjects who consent to provide archival tumor tissue from a biopsy performed within 6 months of consent and performed after treatment with their most recent cancer therapy regimen. If, after all efforts have been made, the fresh pretreatment biopsy is not feasible or the procedure is unsuccessful and an appropriate archival sample is not available, the subject may be considered for study eligib
Prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents including I-DXd, Chronic steroid treatment (dose of 10 mg daily or more prednisone equivalent) except for low-dose inhaled steroids (for asthma/COPD) or topical steroids (for mild skin conditions), or intra-articular steroid injections., History of malignancy other than SCLC within the 3 years prior to enrollment except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial GI tumors and non-muscle invasive bladder cancer curatively resected by endoscopic surgery., History of allogeneic bone marrow, stem cell, or solid organ transplant., Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE V5.0 Grade =1 or baseline., History of hypersensitivity to the drug substances, inactive ingredients in the drug product or severe hypersensitivity reactions to other monoclonal antibodies., Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection., Has active or uncontrolled hepatitis B or C infection; subject is positive for hepatitis B or C virus within 28 days of enrolment., Active, known, or suspected autoimmune disease. The following examples may be enrolled as an exception: a. Type I diabetes mellitus, hypothyroidism only requiring hormone replacement b. Skin disorders not requiring systemic treatment, or c. Conditions not expected to recur in the absence of an external trigger., Any evidence of severe or uncontrolled systemic diseases or other factors that, in the investigator's opinion, make it undesirable for the subject to participate in the study or would jeopardize compliance with the protocol., Has received a live vaccine within 30 days prior to the first dose of study drug., Prior discontinuation of an ADC that consists of an exatecan derivative (eg, trastuzumab deruxtecan), Female who is pregnant or breastfeeding or intends to become pregnant during the study., Prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigators opinion, could affect the safety of the subject; alter the absorption, distribution, metabolism or excretion of the study drug; or confound the assessment of study results., Known HIV infection that is not well controlled., Inadequate washout period before randomization, defined as: a. Major surgery (placement of vascular access will not be regarded as a major surgery) <4 weeks; surgery for low invasive cases (eg, colostomy, <4 weeks) b. Radiation therapy to the lung >30 Gy <6 months; palliative radiotherapy affecting lung areas at lower dose <3 weeks; any other palliative radiotherapy <2 weeks c. Cranial irradiation, including WBRT and SRS, =2 weeks d. Any systemic anticancer therapy <3 weeks or 5 half-lives whichever is longer and <6 weeks for nitrosoureas or mitomycin C e. Antibody-based anticancer therapy <3 weeks f. Chloroquine or hydroxychloroquine =14 days g. Hormonal therapy <2 weeks, Clinically active brain metastases, spinal cord compression or leptomeningeal carcinomatosis, defined as untreated or symptomatic or requiring therapy with steroids or anticonvulsants to control associated symptoms., Any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack or another arterial thromboembolic event., Clinically significant c
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method