This clinical trial aims to assess whether the addition of bevacizumab to atezolizumab and chemotherapy can improve response to treatment and progression-free survival in patients with extensive-stage small cell lung cancer (ES-SCLC) with liver metastases.
The main questions it aims to answer are:
* In patients with ES-SCLC with liver metastases, can bevacizumab in combination with atezolizumab and chemotherapy prolong the length of time that the cancer does not progress? * Is bevacizumab safe and tolerable when combined with atezolizumab and chemotherapy in patients with ES-SCLC and liver metastases?
The study treatment includes two phases:
* Induction phase: bevacizumab will be administered in combination with atezolizumab and chemotherapy on a 21-day cycle for four cycles. * Maintenance: atezolizumab and bevacizumab will be administered every 21 days for up to 12 months, or until unacceptable toxicity or disease progression.
Participants will undergo blood tests every 3 weeks and tumor assessments every 6 weeks.
Ability for subject to sign informed consent form and ability for subject to comply with the requirements of the study.
Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group staging system), and radiographic confirmation of LM at diagnosis.
Patients with history of EGFR mutant non-small cell lung cancer with histologically confirmed transformation to small cell lung cancer with presence of liver metastases, who are chemotherapy and immunotherapy naïve are eligible.
No prior treatment for ES-SCLC. Note: patients who have received prior chemoradiotherapy for limited-stage SCLC must have been treated with curative intent and experienced a treatment-free interval of at least six months since the last chemotherapy, radiotherapy or chemoradiotherapy cycle prior to diagnosis of ES-SCLC
History of leptomeningeal disease
History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the 3 months prior to first dose of protocol therapy.
Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)
Anti-hypertensive therapy to achieve these parameters is allowable.
Single group
Bevacizumab
DrugAddition of Bevacizumab to current standard of care treatment (atezolizumab, carboplatin and etoposide) followed by maintenance Bevacizumab plus Atezolizumab for patients with ES-SCLC with LM
6- month Progression Free Survival (PFS) rate
Proportion of patients with first occurrence of disease progression or death from any cause (whichever occurs first)
Progression Free Survival (PFS)
Time from first dose 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
Overall Survival (OS)
The length of time from date of first study treatment to death of any cause
Objective Response Rate
Percent of patients who have either complete or partial response by CT/MRI imaging based on RECIST v1.1 criteria
Incidence of adverse events
Incidence of adverse events related to study treatment using CTCAE 5.0
Tissue and blood based biomarkers
Identify tissue or blood based biomarkers that are associated with response to treatment with induction ABCE followed by maintenance AB in ES-SCLC patients with LM
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Kamya Sankar
Lead sponsor
Cedars-Sinai Medical Center
Sponsor institution
Genentech, Inc.
Collaborator
University of Michigan
Collaborator
VA Ann Arbor Healthcare System
Collaborator
