Status:
UNKNOWN
Durvalumab (MEDI4736) Plus Platinum-based Chemotherapy in Advanced LCNEC: a Pilot Phase II Study
Lead Sponsor:
Elizabeth Dudnik
Conditions:
Patients With Advanced Treatment Naive LCNEC
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
PROTOCOL SYNOPSIS Clinical Protocol ESR-20-20907 Study Title: Durvalumab (MEDI4736) plus platinum-based chemotherapy in advanced large-cell neuroendocrine tumors of lung (LCNEC): a pilot phase II stud...
Eligibility Criteria
Inclusion
- Advanced- stage (stage IV or stage III not eligible for definitive treatment) LCNEC without prior systemic treatment for advanced disease
- Measurable disease by RECIST 1.1 criteria (at least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline)
- ECOG PS≤1
- Body weight \>30kg
- Life expectancy of at least 3 months
- Brain metastases are allowed providing these are asymptomatic or clinically stable after surgery or radiation therapy (either stereotactic radiotherapy or whole brain radiotherapy), and not requiring corticosteroid therapy
- \- 10 mg prednisone or equivalent are allowed
- Normal hematologic, renal, liver and thyroid function parameters:
- Absolute neutrophil count ≥ 1500/mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 9 g/dL;
- Creatinine clearance ≥ 40 mL/min (≥ 50 mL/min if cisplatin-based regimen will be chosen);
- Total bilirubin ≤ 1.5 mg/dL; ALT+ AST levels £ 2.5 × ULN; for patients with liver metastases £ 5 × ULN;
- TSH within normal limits, if TSH is abnormal - normal total T3/free T3 and free T4
- Female patients with reproductive potential (postmenopausal: ≥ 12 months of non-therapy-induced amenorrhea or surgically sterile) must have a negative pregnancy test (serum/urine) prior to starting treatment
- All female patients with reproductive potential and male patients with partners of childbearing potential, must agree to use barrier contraception methods while receiving the study treatment and for 90 days after stopping the study treatment
- Age ≥18
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up
Exclusion
Key Trial Info
Start Date :
January 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05262985
Start Date
January 31 2022
End Date
January 1 2025
Last Update
March 2 2022
Active Locations (1)
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1
Assuta MC
Tel Aviv, Israel, 69710