Lamivudine with Chemoimmunotherapy for Extensive Stage Small Cell Lung Cancer
This study is looking at how a drug called lamivudine, when combined with standard chemoimmunotherapy, affects people with extensive stage small cell lung cancer. Extensive stage means the cancer has spread. Small cell lung cancer often stops responding to initial treatments, and lamivudine is an antiviral drug that might help prevent this resistance. The standard treatment includes atezolizumab (an immunotherapy), carboplatin, and etoposide (chemotherapy drugs). Researchers want to see if adding lamivudine improves how long people live without their cancer getting worse. You might be able to join if you are at least 18 years old, have extensive stage small cell lung cancer, and meet certain health criteria.
- Study design
- This is a Phase II interventional study planning to enroll 28 participants. It is a single-arm study, meaning all participants receive the same treatment.
- What's involved
- Participants will take lamivudine by mouth daily and receive atezolizumab, carboplatin, and etoposide through an IV. This treatment repeats every 28 days for up to 4 cycles, followed by maintenance treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess how long participants live without their cancer progressing at 6 months, and overall survival at 12 months.
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NCT04696575
Lamivudine in Combination With Chemoimmunotherapy for the Treatment of Extensive Stage Small Cell Lung Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentRoswell Park Cancer InstituteInvestigator-initiated
~28 participants
Updated 2025-12-15 on ClinicalTrials.gov
What's tested:AtezolizumabCarboplatinEtoposideLamivudine
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival
Measured over From the date of registration to the date of first confirmed progression or death, whichever occurred first, assessed at 6 months
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Grace K Dy · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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 ULN is acceptable if liver metastases are present)
Total serum bilirubin =\< 1.5 x ULN. For patients with well documented Gilbert's syndrome, total bilirubin =\< 3 x ULN with direct bilirubin within normal range
Newly diagnosed SCLC patients may receive no more than 1 cycle of standard chemotherapy or chemoimmunotherapy for their current diagnosis prior to study treatment
Patients who have progressed on prior treatment for SCLC will be eligible if both of the following conditions are met:
Received no more than one-line of treatment with platinum-based chemotherapy for SCLC, and
Last platinum-based treatment administered \>= 12 months prior to diagnosis of recurrence/relapse. Patients should not have experienced disease progression while receiving prior platinum-based treatment for SCLC
Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Participant must understand the investigational nature of this study and sign an approved written informed consent form prior to receiving any study related procedure
Symptomatic brain metastasis
Patients with treated brain metastases are eligible provided they have recovered from effects of radiation and neurological symptoms are improved or controlled for at least two weeks prior to enrollment
Patients with asymptomatic brain metastases who are being treated with systemic chemotherapy alone are also eligible if no more than 6 lesions each less than 1 cm in size is present at the time of initiating protocol treatment
Leptomeningeal involvement regardless of treatment status
Participation in another interventional study within the last 28 days of study enrollment
Had major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered major surgery) resulting from a prior surgery
Positive for immunosuppressive disease, acquired immunodeficiency syndrome (AIDS) or other immune depressing diseases. For human immunodeficiency virus (HIV), HVC and HBC-mandatory testing is required prior to enrollment
Note: Patients with past or resolved hepatitis B virus (HBV) infection (defined as the presence of hepatitis B surface antibody \[HBsAb\] and absence of hepatitis B surface antigen \[HBsAg\]) are eligible (HBV deoxyribonucleic acid \[DNA\] should be obtained in patients if only anti-hepatitis B core \[HBc\] antibody was present prior to randomization). Patients with active/untreated hepatitis C virus (HCV) will be excluded from the study; patients who test positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
Active, clinically serious infections or other serious uncontrolled medical conditions, including chronic viral hepatitis (testing for hepatitis B, C required)
Patient has known hypersensitivity to the components of the study drugs or any analogs
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator, including, but not limited to:
Myocardial infarction or arterial or venous thromboembolic events within 6 months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) class III or IV disease
History of documented congestive heart failure (New York Heart Association functional classification III or IV) within 6 months prior to baseline
Poorly controlled arrhythmias
Contraindications to atezolizumab: Patients with active autoimmune disorder or prior history of autoimmune disorder requiring immunosuppressive agents within preceding two years will not be allowed to receive atezolizumab but will be able to receive the other drugs included in the treatment regimen, if eligible
What this trial measures
- Progression-free survivalFrom the date of registration to the date of first confirmed progression or death, whichever occurred first, assessed at 6 months
The primary test of efficacy will be carried out using an exact binomial test of a proportion. Descriptive analyses will be carried out using the Kaplan-Meier product-limit estimator. Patients who are treated beyond RECIST progression and subsequently had tumor response while on study (and no other intervening treatment) will be classified as pseudoprogression and not counted as progression event.