A Phase II Trial of Lamivudine in Combination With Chemoimmunotherapy in Patients With Extensive Stage SCLC
Roswell Park Cancer Institute
Summary
This phase II trial studies the effect of lamivudine in combination with standard of care chemoimmunotherapy in treating patients with extensive stage small cell lung cancer. Even though small cell lung cancer is initially highly responsive to first-line chemotherapy treatment, treatment resistance inevitably emerges; treatment resistance is when tumor cells stop responding to a drug treatment that they had previously responded to. Lamivudine is an oral antiviral a drug that may be able to reduce the ability of tumors to develop drug resistance. Chemotherapy drugs, such as carboplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lamivudine together with the usual standard of care chemoimmunotherapy may help prevent the growth and spread of the tumor cells to other parts of the body.
Description
PRIMARY OBJECTIVE: I. To evaluate the 6-month progression-free survival (PFS) rate of lamivudine in combination with platinum-based chemotherapy in patients with extensive stage small cell lung cancer (SCLC). SECONDARY OBJECTIVES: I. To evaluate the 12-month survival and overall survival (OS) of patients with extensive stage SCLC receiving study treatment. II. To assess the toxicity of the combination of lamivudine with platinum-based chemotherapy in this population. EXPLORATORY OBJECTIVE: I. To study tissue and blood-based biomarkers as potential predictors of treatment outcomes. OUTLI…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age \>= 18 years of age * Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1 at the time of study treatment initiation * Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC) * Patient should have extensive stage disease, defined as, malignant pleural effusion, pulmonary metastases in a different lobe in the ipsilateral lung or contralateral lung, and/or the presence of extra-thoracic metastatic disease * Must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 prior to start…
Interventions
- BiologicalAtezolizumab
Given IV
- DrugCarboplatin
Given IV
- DrugEtoposide
Given IV
- DrugLamivudine
Given PO
Location
- Roswell Park Cancer InstituteBuffalo, New York