A Phase 2 Study of AMG 757 in Patients with Small Cell Lung Cancer (SCLC)
- Conditions
- Relapsed/Refractory Small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code 10041070Term: Small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-002566-40-ES
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 160
101 Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures.
102 Male and female subjects >= 18 years of age (or legal adult age within country) at the time of signing the informed consent.
103 Histologically or cytologically confirmed relapsed/refractory SCLC
104 Subjects who progressed or recurred following 1 platinum-based regimen 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-programmed death ligand 1 (PD-L1) as maintenance therapy is considered 1 line of therapy; (3) in countries where standard of care first line systemic treatment includes platinum containing chemotherapy in combination with PD-L1 inhibitor, it is required that patients to have failed PD-L1 inhibitor as part of their first line systemic treatment or not have access to.
105 Subjects willing to provide archived tumor tissue samples (formalin fixed, paraffin embedded [FFPE] sample) or willing to undergo pretreatment tumor biopsy. Subjects who do not have archived tumor tissue available and are unable to undergo a pretreatment tumor biopsy due to extenuating circumstances (eg, cannot be performed safely or inaccessible, as determined by the investigator) may be allowed to enroll without a tumor biopsy upon agreement between the investigator and Amgen medical monitor.
106 Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
107 Minimum life expectancy of 12 weeks.
108 Measurable lesions as defined per RECIST 1.1 within 21 days prior to the first
dose of AMG 757.
109 Subjects with treated brain metastases are eligible provided they meet the following criteria:
- Definitive therapy was completed at least 2 weeks prior to the first dose of AMG 757.
- There is no evidence of radiographic central nervous system (CNS) progression following definitive therapy and by the time of study screening. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means and after discussion with the medical monitor.
- Any CNS disease is asymptomatic for at least 7 days (unless symptoms are deemed irreversible by the investigator), the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the subject is off or on stable doses of anti-epileptic drugs for malignant CNS disease for at least 7 days.
110 Adequate organ function, defined as follows:
hematological function:
- absolute neutrophil count >= 1 x 10^9/L
- platelet count >= 100 x 10^9/L
- hemoglobin > 9 g/dL (90 g/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). 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) < 3 X ULN (or < 5 X ULN for subjects with liver involvement)
- total bilirubin < 1.5 X ULN (or < 2 X ULN for subjects with live
Disease Related
201 Untreated or symptomatic brain metastases and leptomeningeal disease.
202 Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
203 Subjects who experienced recurrent pneumonitis (grade 2 or higher) or severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
204 Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1, or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible(defined as having been present and stable for > 21 day) which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen.
Other Medical Conditions
205 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 >= 2 years before enrollment and felt 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.
206 Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of AMG 757 (Section 11.9).
207 History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of AMG 757.
208 Presence of fungal, bacterial, viral, or other infection requiring oral or IV antimicrobials for management within 7 days of first dose AMG 757.
NOTE: Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor. Subjects requiring oral antibiotics who have been afebrile > 24 hours, have no leukocytosis or have any clinical signs of infection are eligible. Subjects who meet these criteria and who were previously on IV antimicrobials should have been off IV antimicrobials for > 48 hours.
209 Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter).
NOTE: A pleural catheter or dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted.
210 History of hypophysitis or pituitary dysfunction.
211 Exclusion of hepatitis infection based on the following results and/or criteria:
- Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic
hepatitis B or recent acute hepatitis B).
- Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary.
Detectable hepatitis B virus DNA suggests occult hepatitis B.
- Positive hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C
212 Major surgery within 28 days of fir
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