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
Overview
- Phase
- Phase 2
- Intervention
- Atezolizumab
- Conditions
- Carcinoma, Small Cell Lung
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 56
- Locations
- 8
- Primary Endpoint
- Objective Response Rate
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed ES-SCLC
- •No prior treatment for ES-SCLC
- •Measurable disease, as defined by RECIST v1.
- •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
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
Arms & Interventions
LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab
Participants will receive the following treatment regimens: LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab. Induction treatment will be administered on a 21-day cycle for four cycles. Concurrent radiation therapy will be conducted from Day 1 - Day 5 in the first cycle. Following the induction phase, participants will continue maintenance therapy with atezolizumab. Participants will be treated until loss of clinical benefit, or unaccepted toxicity, or withdrawal of consent, or death (whichever occurs first).
Intervention: Atezolizumab
LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab
Participants will receive the following treatment regimens: LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab. Induction treatment will be administered on a 21-day cycle for four cycles. Concurrent radiation therapy will be conducted from Day 1 - Day 5 in the first cycle. Following the induction phase, participants will continue maintenance therapy with atezolizumab. Participants will be treated until loss of clinical benefit, or unaccepted toxicity, or withdrawal of consent, or death (whichever occurs first).
Intervention: Cisplatin
LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab
Participants will receive the following treatment regimens: LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab. Induction treatment will be administered on a 21-day cycle for four cycles. Concurrent radiation therapy will be conducted from Day 1 - Day 5 in the first cycle. Following the induction phase, participants will continue maintenance therapy with atezolizumab. Participants will be treated until loss of clinical benefit, or unaccepted toxicity, or withdrawal of consent, or death (whichever occurs first).
Intervention: Carboplatin
LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab
Participants will receive the following treatment regimens: LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab. Induction treatment will be administered on a 21-day cycle for four cycles. Concurrent radiation therapy will be conducted from Day 1 - Day 5 in the first cycle. Following the induction phase, participants will continue maintenance therapy with atezolizumab. Participants will be treated until loss of clinical benefit, or unaccepted toxicity, or withdrawal of consent, or death (whichever occurs first).
Intervention: Etoposide
LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab
Participants will receive the following treatment regimens: LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab. Induction treatment will be administered on a 21-day cycle for four cycles. Concurrent radiation therapy will be conducted from Day 1 - Day 5 in the first cycle. Following the induction phase, participants will continue maintenance therapy with atezolizumab. Participants will be treated until loss of clinical benefit, or unaccepted toxicity, or withdrawal of consent, or death (whichever occurs first).
Intervention: Thoracic radiation therapy (TRT)
Outcomes
Primary Outcomes
Objective Response Rate
Time Frame: Baseline up to approximately 36 months
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).
Secondary Outcomes
- Progression Free Survival (PFS)(Baseline to the first occurrence of disease progression or death from any cause (whichever occurs first) (up to approximately 36 months))
- Duration of Response(Baseline to disease progression or death from any cause (whichever occurs first)(up to approximately 36 months))
- Disease Control Rate (DCR)(Baseline up to approximately 36 months)
- PFS Rate at 6 Months and 1 Year(Baseline up to 1 year)
- Percentage of Participants With Adverse Event(Baseline up to approximately 36 months)
- Overall Survival (OS)(Baseline until death (up to approximately 36 months))
- OS Rate at 1 Year and 2 Years(Baseline to 2 years or death, whichever occurs first.)