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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04622228
Other study ID # ML42391
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date December 16, 2020
Est. completion date June 30, 2024

Study information

Verified date June 2024
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 56
Est. completion date June 30, 2024
Est. primary completion date June 21, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases - History of leptomeningeal disease - Uncontrolled tumor-related pain - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures - Uncontrolled or symptomatic hypercalcemia - 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 - Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina - 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

Study Design


Intervention

Drug:
Atezolizumab
Atezolizumab will be administered by intravenous infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, and clinical status.
Cisplatin
Cisplatin will be administered as intravenous infusion at a dose of 75 mg per meter squared (75 mg/m^2) after completion of atezolizumab on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).
Carboplatin
Carboplatin will be administered as intravenous infusion at a dose of area under the concentration-time curve (AUC) of 5 mg/mL/min on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).
Etoposide
Etoposide will be administered intravenously at a dose of 100 mg/m^2 on Days 1, 2 and 3 of each 21-day cycle during the induction phase (Cycles 1-4).
Radiation:
Thoracic radiation therapy (TRT)
Participants will receive concurrent thoracic radiation therapy (TRT) treatment, in once daily fractions, 3 Gy per fraction, to a target dose of 15 Gy in 5 fractions from Day 1-Day 5 in the first cycle.

Locations

Country Name City State
China Cancer Hospital , Chinese Academy of Medical Beijing City
China Hunan Cancer Hospital Changsha CITY
China West China Hospital - Sichuan University Chengdu City
China Second Affiliated Hospital of Third Military Medical University Chongqing
China Shanghai Pulmonary Hospital Shanghai
China Fudan University Shanghai Cancer Center; Medical Oncology Shanghai City
China Tianjin Cancer Hospital Tianjin
China Central South Hospital, Wuhan University Wuhan

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate Objective response rate (ORR), defined as the proportion of participants with a complete response (CR) or partial response (PR) on two consecutive occasions >= 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). Baseline up to approximately 36 months
Secondary Duration of Response Duration of response (DOR), defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1. Baseline to disease progression or death from any cause (whichever occurs first)(up to approximately 36 months)
Secondary Disease Control Rate (DCR) Disease control rate (DCR), defined as the proportion of participants who have a best overall response of CR or PR or stable disease (SD), as determined by the investigator according to RECIST v1.1. Baseline up to approximately 36 months
Secondary Progression Free Survival (PFS) Progression Free Survival (PFS), defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1. Baseline to the first occurrence of disease progression or death from any cause (whichever occurs first) (up to approximately 36 months)
Secondary PFS Rate at 6 Months and 1 Year PFS rate at 6 months and 1 year, defined as the proportion of patients who have not experienced disease progression or death from any cause at 6 months and 1 year separately, as determined by the investigator according to RECIST v1.1. Baseline up to 1 year
Secondary Overall Survival (OS) OS, defined as the time from initiation of study treatment to death from any cause. Baseline until death (up to approximately 36 months)
Secondary OS Rate at 1 Year and 2 Years OS rate at 1 year and 2 years, defined as the proportion of patients who have not experienced death from any cause at 1 year and 2 years. Baseline to 2 years or death, whichever occurs first.
Secondary Percentage of Participants With Adverse Event Baseline up to approximately 36 months
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