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Recruiting Phase 2 NCT04696575

Lamivudine in Combination With Chemoimmunotherapy for the Treatment of Extensive Stage Small Cell Lung Cancer

Trial Parameters

Condition Extensive Stage Lung Small Cell Carcinoma
Sponsor Roswell Park Cancer Institute
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 28
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-07-02
Completion 2027-07-01
Interventions
AtezolizumabCarboplatinEtoposide

Brief 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.

Eligibility Criteria

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 starting platinum-based systemic chemotherapy * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L * Platelets \>= 100 x 10\^9/L * Hemoglobin \>= 9 g/dL * Serum creatinine =\< 1.5 x institution upper limit of normal (ULN) and calculated creatinine clearance of at least 15 ml/min * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x upper limit of normal (ULN) (ALT and AST =\< 5 x

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