Actively Recruiting
A Phase II Trial of Lamivudine Combined With Chemoimmunotherapy for Extensive Stage Small Cell Lung Cancer
Led by Roswell Park Cancer Institute ยท Updated on 2025-12-15
28
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effect of lamivudine combined with standard chemoimmunotherapy in patients with extensive stage small cell lung cancer (SCLC). This phase II trial explores whether lamivudine, an oral antiviral drug, can help reduce tumor resistance to treatment, which often develops after initial response to chemotherapy. The study also evaluates survival rates and potential treatment side effects while examining biomarkers that may predict outcomes. Participants receive lamivudine orally once daily along with carboplatin, etoposide, and atezolizumab intravenously during the induction phase, which lasts up to four 28-day cycles if there is no disease progression or unacceptable toxicity. In the maintenance phase, lamivudine and atezolizumab continue every 28 days under the same conditions. Patients not eligible for or refusing atezolizumab still receive carboplatin, etoposide, and lamivudine. During the study, patients undergo regular assessments for tumor progression, survival, and treatment toxicity, with follow-up visits extending 30 days after treatment and continuing every 60 days. Researchers collect tissue and blood samples to study biomarkers. The primary outcome is progression-free survival at six months, with secondary outcomes including overall survival and treatment side effects. Participation continues until disease progression, unacceptable toxicity, or patient withdrawal.
CONDITIONS
Brief Title
Lamivudine in Combination With Chemoimmunotherapy for the Treatment of Extensive Stage Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at treatment start
- Histologically or cytologically confirmed small cell lung cancer
- Extensive stage disease with specific spread to lungs or other organs
- Measurable disease based on RECIST 1.1 before starting platinum-based chemotherapy
- Absolute neutrophil count (ANC) at least 1.5 x 10^9/L
- Platelet count at least 100 x 10^9/L
- Hemoglobin level at least 9 g/dL
- Serum creatinine at or below 1.5 times upper limit of normal and creatinine clearance at least 15 ml/min
- Liver enzymes (ALT and AST) at or below 3 times upper limit of normal (up to 5 times if liver metastases present)
- Total serum bilirubin at or below 1.5 times upper limit of normal (up to 3 times with normal direct bilirubin for Gilbert's syndrome)
- Newly diagnosed patients may have received no more than 1 cycle of standard chemotherapy or chemoimmunotherapy
- Patients with prior platinum-based treatment are eligible if only one line was given and last treatment was at least 12 months ago without progression during treatment
- Agreement to use effective contraception if of child-bearing potential
- Ability to understand and sign informed consent
You will not qualify if you...
- Received anticancer chemotherapy or chemoimmunotherapy within 4 weeks prior to study drug, except as allowed
- Symptomatic brain metastases (treated and stable or asymptomatic with limited small lesions allowed)
- Leptomeningeal disease
- Participation in another interventional study within 28 days before enrollment
- Major surgery within 14 days before study drug or not fully recovered from major surgery side effects
- Positive for immunosuppressive diseases like AIDS or other immune disorders; specific hepatitis B and C virus infection rules apply
- Active, serious infections or other uncontrolled serious medical conditions
- Known allergy to study drugs or related compounds
- Recent serious heart conditions or poorly controlled arrhythmias
- Contraindications to atezolizumab, such as active autoimmune disorders requiring immunosuppressive treatment within the last two years (may still receive other drugs if eligible)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 cycles of induction and ongoing maintenance cycles every 28 days until disease progression or unacceptable toxicity
Participants receive lamivudine orally daily and chemoimmunotherapy including carboplatin, atezolizumab, and etoposide intravenously in 28-day cycles. The induction phase lasts up to 4 cycles with lamivudine daily and carboplatin, atezolizumab, and etoposide given on specific days of each cycle. This is followed by maintenance cycles with lamivudine daily and atezolizumab on day 1 of each 28-day cycle. Treatment continues until disease progression or unacceptable toxicity.
Cycles repeat every 28 days with multiple visits per cycle for infusions and daily oral medication
Duration - 30 days initially, then every 60 days thereafter
After completing treatment, participants are followed up to monitor health status and any delayed effects of treatment.
Visits every 60 days after the first 30-day follow-up
Trial Site Locations
Total: 1 location
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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