🏛️ Verified NIH Record • Updated 2025-12-09

Lamivudine in Combination With Chemoimmunotherapy for the Treatment of Extensive Stage Small Cell Lung Cancer (NCT04696575)

A Phase II Trial of Lamivudine in Combination With Chemoimmunotherapy in Patients With Extensive Stage SCLC

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Roswell Park Cancer Institute

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (17 items) and avoid the listed exclusions (17 items).

Location: Roswell Park Cancer Institute — Buffalo, New York

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Receipt of anticancer chemotherapy/chemoimmunotherapy within 4 weeks prior to the first administration of study drug other than what is allowed in the inclusion criteria
  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • Roswell Park Cancer Institute — Buffalo, New York

📞 Contact the Study Coordinator

Phone: (716) 845-8297

Email: Grace.Dy@roswellpark.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
  • 💵 Compensation indicated: 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 stand...

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗