Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- * Ability to understand and sign an informed consent form
- * Male or female ≥ 18 years of age
- * Histologically or cytologically confirmed SCLC
- * R/R ES-SCLC on or after platinum-based chemotherapy for SCLC with documented disease progression
- * At least 1 measurable lesion as defined by RECIST 1.1
- * Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 or 1
- * Life expectancy of at least 3 months
- * Adequate organ function as described in the protocol
- * For female or male patients with reproductive potential: Agree to use contraception throughout the study and at least 5 months after the last dose.
- * Known active leptomeningeal disease (carcinomatous meningitis)
- * Known active and uncontrolled central nervous system (CNS) metastases
- * Treatment with immunotherapy, chemotherapy, targeted small molecule therapy, or any other investigational agent \< 14 days prior to initiation of study treatment
- * Treatment with radiation therapy \< 14 days prior to initiation of study treatment
- * Major surgery \< 21 days prior to initiation of study treatment
- * Received live vaccine \< 30 days prior to initiation of study treatment, including intranasal influenza vaccine
- * History of another primary malignancy with protocol-defined exceptions
- * Active or history of autoimmune disease requiring systemic treatment
- * Receiving high doses of steroids or other immunosuppressive medications
- * Active hepatitis B or C infection
- * Active or history of non-infectious pneumonitis requiring treatment with steroids
- * Active uncontrolled viral, fungal, or bacterial infection including tuberculosis
- * Pregnant or breastfeeding female patients
- * History of severe hypersensitivity reaction to a monoclonal antibody treatment
- * History of severe hypersensitivity reaction or ≥ Grade 3 adverse event (AE) to paclitaxel treatment
- * History of cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms within 6 months prior to screening
- * QT Corrected for Fridericia's method (QTcF) \> 470 ms at screening
- * Lack of resolution of any toxicity to max Grade 1 (except alopecia)
- * Active or history of any condition, therapy, or lab abnormality that may interfere with the patient participation for the full duration of the study
- * Known psychiatric or substance use disorder
- * Positive Coronavirus disease 2019 (COVID-19) test at screening
Ages Eligible for Study
18 Years to
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No