Using lamivudine with chemoimmunotherapy for extensive stage small cell lung cancer

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

This study is testing if adding lamivudine to standard chemoimmunotherapy can help people with extensive stage small cell lung cancer live longer and stay cancer-free for longer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Roswell Park Cancer Institute (other)
• Drugs / interventions: atezolizumab, chemotherapy, radiation, Immunotherapy
• Locations: 1 site (Buffalo, New York)
• Trial ID: NCT04696575 on ClinicalTrials.gov

What this trial studies

This phase II trial investigates the effects of lamivudine combined with standard chemoimmunotherapy on patients with extensive stage small cell lung cancer (SCLC). The study aims to evaluate the 6-month progression-free survival rate and overall survival of patients receiving this combination treatment. Lamivudine, an oral antiviral, may help prevent drug resistance in tumors, while chemotherapy and immunotherapy work to kill cancer cells and enhance the immune response against the cancer. Patients will receive lamivudine alongside carboplatin and etoposide, with the option of including atezolizumab, depending on eligibility. The study also explores biomarkers that could predict treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of extensive stage small cell lung cancer and measurable disease.

Not a fit: Patients with limited stage small cell lung cancer or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could improve survival rates and delay disease progression for patients with extensive stage small cell lung cancer.

How similar studies have performed: While the combination of lamivudine with standard treatments is novel, previous studies have shown success with similar approaches in enhancing treatment efficacy for resistant cancers.

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 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

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
* 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

Where this trial is running

Buffalo, New York

• Roswell Park Cancer Institute — Buffalo, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Grace K Dy — Roswell Park Cancer Institute

Conditions: Extensive Stage Lung Small Cell Carcinoma