Small Cell Lung Cancer (SCLC)
Conditions
Interventions
Tarlatamab Group:Tarlatamab
Sponsors
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Subject has provided informed consent prior to initiation of any study specific activities/procedures. 2.Subjects must be a resident in China, and of Chinese ancestry =18 years of age (or legal adult age within country) at the time of signing the informed consent. 3.Histologically or cytologically confirmed SCLC. 4.Subjects who progressed on or recurred following 1 platinum-based regimen as 1L therapy (including a PD-1/ PD-[L]1) and at least 1 other prior line of therapy. Note: (1) re-treatment with a platinum-based regimen is considered a second-line of therapy; (2) platinum-based regimen followed by checkpoint inhibitor/anti-PD-L1 as maintenance therapy is considered 1 line of therapy. 5.Measurable lesions as defined per RECIST 1.1 within 21 days prior to the first dose of tarlatamab. Screening scans performed as standard of care (SOC) and prior to informed consent, may be used to confirm subject eligibility if completed within the 21-day screening period. 6.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 7.Minimum life expectancy of 12 weeks. 8.Adequate organ function, defined as follows: hematological function: absoluteneutrophilcount = 1x109/L, plateletcount = 100x109/L, hemoglobin>9g/dL(90g/L). coagulation function: prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) = 1.5 x institutional upper limit of normal (ULN) except for subjects undergoing new class anticoagulant therapy (eg, Edoxaban), stable dose for 2 weeks required. Subjects on chronic anticoagulation therapy who do not meet the criteria above may be eligible to enroll after discussion with the medical monitor. renal function: estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculation > 30 mL/min/1.73 m2. hepatic function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) 90%onroomair. cardiac function: cardiac ejection fraction = 50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no clinically significant electrocardiogram (ECG) findings;
Exclusion criteria
Exclusion criteria: 1.Any previous diagnosis of transformed non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC. Subjects with mixed histology tumors with predominant SCLC histology are allowed. 2.Symptomatic CNS metastases: Subjects with treated brain metastases are eligible provided the following criteria are met: - Subject is asymptomatic from brain metastases - Whole brain radiation or surgery was completed at least 2 weeks prior to first dose of study treatment (stereotactic radiosurgery completed at least 7 days prior to first dose of study treatment) - Any CNS disease is clinically stable, subject is off steroids for CNS disease for at least 5 days (unless steroids are indicated for a reason unrelated to CNS disease), and subject is off or on stable doses of anti-epileptic drugs at least 14 days prior to first dose of study treatment. Subject with untreated brain metastasis that are asymptomatic and do not require corticosteroids, nor local therapy per investigators standard of practice are allowed; 3.Diagnosis or evidence of leptomeningeal disease. 4.Prior history of immune checkpoint inhibitors resulting in: Any severe or life-threatening immune-mediated adverse event . History of immune-mediated encephalitis or other immune-mediated CNS event (any grade) . Grade = 2 immune-mediated recurrent pneumonitis. Infusion-related reactions leading to permanent discontinuation of immunotherapy agent Exception: Subjects with a history of immune checkpoint inhibitor-induced endocrinopathy which is clinically stable on replacement therapy. 5.Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. 6.History of solid organ transplantation. 7.Evidence of interstitial lung disease or active, non-infectious pneumonitis. 8.History of other malignancy within the past 2 years, with the following exceptions: malignancy treated with curative intent and with no known active disease present for = 1 year before enrollment and believed to be at low risk for recurrence by the treating physician . adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease , adequately treated cervical carcinoma in situ without evidence of disease . adequately treated breast ductal carcinoma in situ without evidence of disease . prostatic intraepithelial neoplasia without evidence of prostate cancer . adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ; 9.Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of tarlatamab; 10.History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of tarlatamab. 11.Subject with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of tarlatamab. Subject has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the subject may be considered eligible for the study from an infection standpoint. NOTE: Simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment. Subjects requiring oral antibiotic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| During of response(DOR);Disease Control Rate (DCR);Progression-Free Survival(PFS);Overall Survival(OS);TEAE;Serum concentration of tarlatamab;Incidence of anti-tarlatamab antibody formation; | — |
Countries
China
Contacts
Public ContactQian Chu
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Outcome results
None listed