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Extensive Stage Lung Small Cell CarcinomaPhase 2NCT04696575

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

A Phase 2 study testing Atezolizumab, Carboplatin and Etoposide in people with Extensive Stage Lung Small Cell Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atezolizumab, Carboplatin and Etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
2 Jul 2021to 1 Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Grace K. Dy, 716-845-8297, Grace.Dy@roswellpark.org

    Grace K. Dy

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the 6-month progression-free survival (PFS) rate of lamivudine in combination with platinum-based chemotherapy in patients with extensive stage small cell lung cancer (SCLC).

SECONDARY OBJECTIVES:

  1. To evaluate the 12-month survival and overall survival (OS) of patients with extensive stage SCLC receiving study treatment.

II. To assess the toxicity of the combination of lamivudine with platinum-based chemotherapy in this population.

EXPLORATORY OBJECTIVE:

  1. To study tissue and blood-based biomarkers as potential predictors of treatment outcomes.

OUTLINE:

INDUCTION: Patients receive lamivudine orally (PO) once daily (QD) on days 1-28. Patients also receive carboplatin intravenously (IV) over 30-60 minutes and atezolizumab IV on day 1, and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive lamivudine PO QD on days 1-28 and atezolizumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

NOTE: Patients who are not eligible for atezolizumab as outlined in exclusion criteria or who refuse to receive atezolizumab may still be treated in this study with carboplatin and etoposide as the IV drug component, in addition to lamivudine orally administered.

After completion of study treatment, patients are followed up for 30 days and then every 60 days thereafter.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabBiological

    Also called MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A

    Given IV

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • EtoposideDrug

    Also called Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar

    Given IV

  • LamivudineDrug

    Also called (-)-BCH-189, 3TC, Epivir, GR109714X

    Given PO

Study groups in NCT04696575
Study groupRoleWhat they receive
Treatment (lamivudine, chemoimmunotherapy)ExperimentalINDUCTION: Patients receive lamivudine PO QD on days 1-28. Patients also receive carboplatin IV over 30-60 minutes and atezolizumab IV on day 1, and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive lamivudine PO QD on days 1-28 and atezolizumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are not eligible for atezolizumab as outlined in exclusion criteria or who refuse to receive atezolizumab may still be treated in this study with carboplatin and etoposide as the IV drug component, in addition to lamivudine orally administered.
Receives: Biological: Atezolizumab; Drug: Carboplatin; Drug: Etoposide; Drug: Lamivudine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    The primary test of efficacy will be carried out using an exact binomial test of a proportion. Descriptive analyses will be carried out using the Kaplan-Meier product-limit estimator. Patients who are treated beyond RECIST progression and subsequently had tumor response while on study (and no other intervening treatment) will be classified as pseudoprogression and not counted as progression event.

    Measured: From the date of registration to the date of first confirmed progression or death, whichever occurred first, assessed at 6 months

Secondary outcomes (2)

  1. Overall survival

    Descriptive analyses will be carried out using the Kaplan-Meier product-limit estimator.

    Measured: From registration to death from any cause or 5 years from time of enrollment, whichever occurs first

  2. Incidence of toxicities

    Per National Cancer Institute Common Terminology Criteria for Adverse Events version 5, the term toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded for each patient and will be used for reporting. Frequency tables will be reviewed to determine toxicity patterns. In addition, all adverse event data graded as 3, 4, or 5 and classified as either "unrelated or unlikely to be related" to study treatment in the event of an actual relationship developing will be reviewed.

    Measured: Up to 30 days after the end of all treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2021
  2. Study start2 Jul 2021
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04696575
Sponsor's protocol ID
I 691720
Other IDs
NCI-2020-13169, I 691720
Status last verified
Dec 2025
First submitted
4 Jan 2021
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab, Carboplatin and Etoposide in people with Extensive Stage Lung Small Cell Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: From the date of registration to the date of first confirmed progression or death, whichever occurred first, assessed at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04696575.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.

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