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New treatment option for Extensive Stage Lung Small Cell Carcinoma
Official title Lamivudine in Combination With Chemoimmunotherapy for the Treatment of Extensive Stage Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT04696575
What this study is testing
What is Atezolizumab?
Atezolizumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for extensive stage lung small cell carcinoma.
Also referred to as MPDL 3280A, MPDL 328OA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 prior to starting platinum-based systemic chemotherapy
You likely can't join if
- Receipt of anticancer chemotherapy/chemoimmunotherapy within 4 weeks prior to the first administration of study drug other than what is allowed in...
- Symptomatic brain metastasis
- Patients with treated brain metastases are eligible provided they have recovered from effects of radiation and neurological symptoms are improved or...
- Patients with asymptomatic brain metastases who are being treated with systemic chemotherapy alone are also eligible if no more than 6 lesions each...
- Leptomeningeal involvement regardless of treatment status
- Participation in another treatment study within the last 28 days of study enrollment
See the full eligibility criteria
Who can join
- 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...
- 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...
- Participant must understand the investigational nature of this study and sign an approved written informed consent form prior to receiving any study related procedure
What rules you out
- 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...
- Leptomeningeal involvement regardless of treatment status
- Participation in another treatment 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Buffalo, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buffalo, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.