A phase II, single arm study of CarbopLatin plus Etoposide with Bevacizumab and Atezolizumab in patients with exTEnded-disease small-cell lung cancer (SCLC) – CeLEBrATE trial

Phase 1

• Conditions: Patients with extended-disease small-cell lung cancer (SCLC); MedDRA version: 21.1Level: PTClassification code 10041067Term: Small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-003798-25-IT
• Lead Sponsor: GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-27
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

•Histologically or cytological documented small cell lung cancer (SCLC) or poorly differentiated (G3) neuroendocrine carcinoma of the lung
•Extensive stage
•No prior chemotherapy or treatment with another systemic anti-cancer agent
•No need for concomitant chest irradiation
•Males or females, age = >18 years
•ECOG performance status 0-1
•Life expectancy > 12 weeks
•Adequate hepatic and renal functions
•Adequate hematologic function,
•The patient has adequate coagulation
•Negative HIV test at screening with respect of any applicable law and the indication of Atezolizumab use.
•Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
The HBV DNA test will be performed only for patients who have a positive total HBcAb test
•Negative hepatitis C virus (HCV) antibody test at screening
•Female patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to first dose of protocol therapy.
•Male patients who are sexually active must use effective contraception during treatment with chemotherapy and for at least 6 months after the final dose of chemotherapy to avoid
exposing the embryo. Men must refrain from donating sperm during this same period.
•For female patients of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception
•Ability to comply with the study protocol, in the investigator's judgment
•The patient must give written (personally signed and dated) informed consent before completing any study related procedure
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

•The patient has experienced any Grade 3-4 gastrointestinal bleeding within 3 months prior to first dose of protocol therapy.
•The patient has a history of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism
•Symptomatic brain metastases or spinal cord compression
•History of leptomeningeal disease
•Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
•Uncontrolled or symptomatic hypercalcemia Active tubercolosis.
•Significant traumatic injury or radiotherapy The patient experienced hemoptysis
•Other malignancies (previous or currentThe patient has experienced any arterial thromboembolic events,
•The patient has uncontrolled or poorly-controlled hypertension Prior history of hypertensive crisis or hypertensive encephalopathy.
•Significant vascular disease) within 6 months prior to registration.
•The patient has a prior history of gastrointestinal or non-gastrointestinal fistula as well as gastrointestinal perforation (within 6 months of first dose of protocol therapy) or risk factors for perforation
•The patient has a serious or nonhealing wound, ulcer, or bone fracture Evidence of bleeding diathesis or coagulopathy
•Major surgery (including open biopsy) Prior allogeneic stem cell or solid organ transplantation
•Patients with any underlying medical condition that might be aggravated by treatment or which cannot be controlled Concomitant treatment with any other anti-cancer drug
•Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to starting study treatment
•Evidence of any other disease, Active, known or suspected autoimmune disease.
•Patient has received a live-virus vaccination within 30 days of planned treatment start. Active infection requiring therapy.
•Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), Hepatitis B (HBV) or Hepatitis C (HCV).
•History of idiopathic pulmonary fibrosis, Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, CD137 agonists.
•Treatment with systemic immunostimulatory agents Any condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
•History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject’s participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.
•History of allergies or hypersensitivity to any study drugs or study drug components.
•The patient is pregnant or breast-feeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified