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NCT04622228CompletedPhase 2

Study of Low-Dose Radiotherapy (LDRT) Concurrent Cisplatin/Carboplatin Plus Etoposide With Atezolizumab for Patients With Extensive-Stage Small Cell Lung Cancer

Phase II, Single-Arm Study of Low-Dose Radiotherapy (LDRT) Concurrent Cisplatin/Carboplatin Plus Etoposide With Atezolizumab for Patients With Extensive-Stage Small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 29 Jul 2024

Brief summary (registry, in English)

This is a Phase II, single arm, multicenter study designed to evaluate the safety and efficacy of low-dose radiotherapy (LDRT) concurrent cisplatin/carboplatin plus etoposide with atezolizumab in participants who have extensive-stage small cell lung cancer (ES-SCLC) and are chemotherapy-navïe for their extensive-stage disease.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
56 (actual)
First submitted
4 Nov 2020
Start date
16 Dec 2020
Primary completion date
21 Jun 2022
Lead sponsor
Hoffmann-La Roche
Diseases
Lung cancer
NCT number
NCT04622228

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 56
  • From 16 Dec 2020 to the primary completion date, 21 Jun 2022
  • 8 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina

Other illness

  • History of leptomeningeal disease
  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • Active tuberculosis
  • History of malignancy other than small cell lung cancer (SCLC) within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death

Other

  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  • Uncontrolled tumor-related pain
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
  • Uncontrolled or symptomatic hypercalcemia

Who the study is looking for

  • Histologically or cytologically confirmed ES-SCLC
  • No prior treatment for ES-SCLC
  • Measurable disease, as defined by RECIST v1.1. Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation.
  • ECOG performance status of 0 or 1
  • Life expectancy \>= 3 months
  • Adequate hematologic and end-organ function
  • For participants receiving therapeutic anticoagulation: stable anticoagulant regimen
  • Negative human immunodeficiency virus (HIV) test at screening
  • Negative hepatitis B surface antigen (HBsAg) test at screening
  • Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: Negative total hepatitis B core antibody (HBcAb), or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test. The HBV DNA test must be performed for participants who have a negative HBsAg test, a negative HBsAb test, and a positive total HBcAb test.
  • Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test must be performed for participants who have a positive HCV antibody test.
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cancer Hospital , Chinese Academy of Medical
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Hunan Cancer Hospital
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ChangshaChinaUnknown status
West China Hospital,Sichuan University
Coordinator of this site? Confirm its status
ChengduChinaUnknown status
Second Affiliated Hospital of Third Military Medical University
Coordinator of this site? Confirm its status
ChongqingChinaUnknown status
Shanghai Pulmonary Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Fudan University Shanghai Cancer Center; Medical Oncology
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Tianjin Cancer Hospital
Coordinator of this site? Confirm its status
TianjinChinaUnknown status
Central South Hospital, Wuhan University
Coordinator of this site? Confirm its status
WuhanChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.