RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 30 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "After completion of study treatment, patients are followed up for 30 days and then every 60 days thereafter."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests adding lamivudine, a pill used to treat viruses, to usual chemotherapy and immune-based treatment. It is for adults with small cell lung cancer that has spread widely. Researchers want to learn if lamivudine helps keep the cancer from growing or becoming resistant, meaning treatment stops working.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have small cell lung cancer confirmed by a tissue or cell test, with cancer spread to other lung areas, fluid around the lungs, or outside the chest.
  • Be fully active or able to do light work despite some limits on hard physical activity.
  • Have cancer that could be measured before starting platinum-based chemotherapy.
  • Have blood counts and kidney and liver test results within the study’s required ranges.
  • If newly diagnosed, have had no more than 1 cycle of chemotherapy or chemotherapy with immune-based treatment. If cancer has returned, have had only 1 prior course of platinum-based treatment, with no worsening during treatment, and at least 12 months between the last treatment and the cancer’s return.
  • If able to become pregnant, agree to use birth control or avoid sex before joining. Tell the doctor right away if pregnancy occurs or is suspected during the study.
  • Understand that the treatment is being studied and sign a consent form before any study procedures.

Who can't join

  • Had chemotherapy or chemotherapy with immune-based treatment in the past 4 weeks, except treatment allowed above; or joined another study testing a treatment in the past 28 days.
  • Have brain cancer spread that causes symptoms. Treated brain spread may be allowed after recovery from radiation and at least 2 weeks of improved or controlled symptoms. Brain spread without symptoms may be allowed with chemotherapy alone if there are no more than 6 spots, each smaller than 1 cm.
  • Have cancer spread to the tissue covering the brain or spinal cord, even if treated.
  • Had major surgery in the past 14 days or have not recovered from major side effects of surgery. A tumor biopsy does not count as major surgery.
  • Have AIDS, another disease that weakens the immune system, a serious active infection, or a serious uncontrolled illness. HIV and hepatitis B and C testing is required. Past, cleared hepatitis B may be allowed; a positive hepatitis C antibody test is allowed only if testing finds no active virus.
  • Have a known allergy to the study drugs, their ingredients, or similar drugs.
  • Have a condition, treatment, or test result that the study doctor thinks makes joining unsafe or affects the study. Examples include a heart attack or blood clot in the past 6 months, severe heart failure, severe or unstable chest pain, or poorly controlled heartbeat problems.
  • Cannot receive atezolizumab if you have an active disease where the immune system attacks the body, or a past such disease needing immune-suppressing drugs within 2 years. You may still receive the other study drugs if otherwise eligible.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NY