DS-7300a 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 stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2022-000503-13-FR
- Lead Sponsor
- Daiichi Sankyo, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 140
1. Sign and date the informed consent form (ICF) prior to the start of any study- specific qualification procedures.
2. Subject must have at least one lesion, not previously irradiated, amenable to core biopsy. Consent to provide a pretreatment biopsy tissue sample and on-treatment biopsy.
3. Male or female subjects aged =18 years .
4. Histologically or cytologically documented ES-SCLC.
5. At least one measurable lesion according to RECIST v1.1 as assessed by the investigator.
6. Prior therapy with at least one prior platinum-based line as systemic therapy for extensive-stage disease. Subjects with or without prior immune-checkpoint inhibitor therapy are eligible. Subject must not have received more than three previous lines of systemic therapy (re-challenge with platinum chemotherapy will be considered as one prior line of therapy).
7. Documentation of radiological disease progression on or after most recent systemic therapy.
8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
9. Life-expectancy =3 months.
10. Required baseline local laboratory data (within 7 days prior to Cycle 1 Day 1):
a. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST): ? =3 × upper limit of normal (ULN) in subjects with no liver metastasis and ? =5.0 × ULN in subjects with liver metastasis
b. Total bilirubin =1.5 × ULN (=3 × ULN total and =1.5 × ULN direct bilirubin is acceptable for subjects with Gilbert’s syndrome)
c. Absolute neutrophil count (ANC) =1.5 × 109/L (hematopoietic growth factors [eg, granulocyte colony stimulating factor {G-CSF}, granulocyte-macrophage colony-stimulating factor {GM-CSF}] support allowed up to 14 days before randomization)
d. Platelet count =100 × 109/L (platelet transfusion is allowed up to 14 days before randomization)
e. Hemoglobin =8.5 g/dL (transfusion and/or growth factor support allowed up to 14 days before randomization)
f. Creatinine clearance =50 mL/min, as calculated using the Cockcroft-Gault equation
g. International Normalized Ratio (INR)/prothrombin time (PT) and either partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) =1.5 × ULN
11. 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 follicle stimulating hormone (FSH) test.
12. 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.
13. 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.
14. 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 las
1. Prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents
2. Prior treatment with an ADC that consists of an exatecan derivative (eg, trastuzumab deruxtecan)
3. Inadequate washout period before Cycle 1 Day 1, defined as:
a. Major surgery as deemed by the investigator <3 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 whole brain radiation therapy and stereotactic radiosurgery, <2 weeks
d. Any systemic anticancer therapy <3 weeks and <6 weeks for nitrosoureas or mitomycin C or 5 half-lives, whichever is longer
e. Antibody-based anticancer therapy <3 weeks
f. Chloroquine or hydroxychloroquine <14 days
4. 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
5. Any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack or another arterial thromboembolic event
6. Clinically significant corneal disease
7. Uncontrolled or significant cardiovascular disease, including:
a. QTcF interval >470 ms based on average of the screening triplicate 12-lead determinations
b. Diagnosed or suspected long QT syndrome, or known family history of long QT syndrome
c. History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes
d. Bradycardia of less than 50 bpm unless the subject has a pacemaker
e. History of second- or third-degree heart block
f. Acute myocardial infarction within 6 months prior to screening
g. Uncontrolled angina pectoris within 6 months prior to screening
h. Symptomatic congestive heart failure defined as New York Heart Association Class 2 to 4
i. Coronary/peripheral artery bypass graft or any coronary/peripheral angioplasty within 6 months prior to screening
j. Grade =3 hypertension
k. Complete left or right bundle branch block
l. Left ventricular ejection fraction <50% by either an echocardiogram or a multigated acquisition scan
8. History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
9. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, and potential pulmonary involvement caused by any autoimmune, connective tissue or inflammatory disorders, prior complete pneumonectomy, or requirement for supplemental oxygen.
10. Chronic steroid treatment, except for low-dose inhaled steroids (for asthma/COPD) or topical steroids (for mild skin conditions)
11. 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 gastrointestinal tract tumors and non-muscle invasive bladder cancer curatively resected by endoscopic surgery
12. History of allogeneic bone marrow, stem cell, or solid organ transplant
13. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE V5.0, Grade =1 or baseline
14. History of hypersensitivity to the
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