A Phase 2 Study of Tarlatamab in Patients with Small Cell Lung Cancer (SCLC)
- Conditions
- MedDRA version: 21.1Level: PTClassification code 10041070Term: Small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Relapsed/Refractory Small Cell Lung CancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-002566-40-GR
- 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 have failed PD-L1 inhibitor as part of their first
line systemic treatment or are ineligible to receive PD-L1 inhibitor
therapy.
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 Tarlatamab.
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 Tarlatamab.
- 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 (o
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
Tarlatamab (Section 11.9).
207 History of arterial thrombosis (eg, stroke or transient ischemic
attack) within 12 months of first dose of Tarlatamab.
208 Presence of fungal, bacterial, viral, or other infection requiring oral
or IV antimicrobials for management within 7 days of first dose
Tarlatamab.
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
peritoneal/pericardial catheter).
NOTE: A pleural catheter or dedicated central venous access catheters
such as a Port-a-Cath or Hickman catheter are permitted.
XML File Identifier: HsViRNhd09w6/k16fxcMvdwgGGQ=
Page 25/39
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 sugges
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