Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04696575

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

Led by Roswell Park Cancer Institute · Updated on 2025-12-15

28

Participants Needed

1

Research Sites

312 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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 diagnosis of small cell lung cancer (SCLC)
  • Extensive stage disease defined by malignant pleural effusion, pulmonary metastases in different lung lobes, or extra-thoracic metastases
  • Measurable disease based on RECIST 1.1 before starting 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 no greater than 1.5 times institution upper limit normal and creatinine clearance at least 15 ml/min
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) no greater than 3 times upper limit normal (up to 5 times if liver metastases present)
  • Total serum bilirubin no greater than 1.5 times upper limit normal (up to 3 times if Gilbert's syndrome and normal direct bilirubin)
  • Newly diagnosed patients may have had no more than 1 cycle of chemotherapy or chemoimmunotherapy for current diagnosis
  • Patients with prior treatment eligible if only one line of platinum-based chemotherapy received and last treatment was at least 12 months before relapse with no progression during treatment
  • Participants of child-bearing potential must agree to use effective contraception
  • Ability to understand study and sign informed consent
Not Eligible

You will not qualify if you...

  • Receipt of anticancer chemotherapy or chemoimmunotherapy within 4 weeks before study drug except as allowed
  • Symptomatic brain metastases (treated brain metastases allowed if symptoms controlled and recovered for at least 2 weeks; asymptomatic brain metastases with no more than 6 lesions under 1 cm allowed)
  • Leptomeningeal involvement
  • Participation in another interventional study within 28 days before enrollment
  • Major surgery within 14 days before study drug or unresolved major side effects from prior surgery
  • Positive for immunosuppressive or immune depressing diseases such as AIDS
  • Active untreated hepatitis C virus infection; past hepatitis B infection allowed if DNA testing performed
  • Active serious infections or uncontrolled medical conditions including chronic viral hepatitis
  • Known allergy to study drugs or their components
  • History of recent severe heart conditions including myocardial infarction, unstable angina, congestive heart failure (NYHA class III or IV), or poorly controlled arrhythmias
  • Contraindications to atezolizumab including active or recent autoimmune disorders requiring immunosuppressive treatment within 2 years (patients may still receive other drugs if eligible)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Actively Recruiting

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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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