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Checkpoint Inhibitor

Lamivudine + Chemoimmunotherapy for Small Cell Lung Cancer

Phase 2

Recruiting

Led By Grace K Dy

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Received no more than one-line of treatment with platinum-based chemotherapy for SCLC, and

Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC)

Must not have

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

Active, clinically serious infections or other serious uncontrolled medical conditions, including chronic viral hepatitis (testing for hepatitis B, C required)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from registration to death from any cause or 5 years from time of enrollment, whichever occurs first

Awards & highlights

No Placebo-Only Group

Summary

This trial studies if adding lamivudine to standard treatment can help patients with advanced small cell lung cancer. Lamivudine may prevent cancer cells from becoming resistant, while the standard treatment kills the cells and boosts the immune system.

Who is the study for?

Adults with extensive stage small cell lung cancer who have measurable disease, acceptable organ function, and an ECOG performance status of 0 or 1. They may have had one cycle of chemoimmunotherapy but no more than one prior line of platinum-based treatment at least a year ago without progression during that treatment. Participants must not be HIV positive or have certain other health conditions.

What is being tested?

The trial is testing the effectiveness of adding lamivudine to standard chemoimmunotherapy (carboplatin, etoposide, and atezolizumab) for treating extensive stage small cell lung cancer. The goal is to see if lamivudine can help prevent the tumor from becoming resistant to therapy.

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as inflammation in various organs, fatigue, digestive issues like nausea and diarrhea, blood-related problems including low counts leading to increased infection risk, liver enzyme changes, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had only one round of platinum-based chemotherapy for small cell lung cancer.

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My lung cancer diagnosis was confirmed through lab tests.

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My cancer has spread beyond my lungs.

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I have small cell lung cancer and have had only one round of chemotherapy or chemoimmunotherapy.

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I can carry out all my self-care but cannot work.

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I am 18 years old or older.

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My kidney function tests are within normal range.

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My cancer can be measured and tracked using specific criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition that weakens my immune system, such as HIV/AIDS.

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I do not have any serious infections or uncontrolled conditions, including hepatitis.

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My cancer has spread to the lining of my brain and spinal cord.

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I have irregular heartbeats that are not well-managed.

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I have brain metastasis causing symptoms.

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I haven't had major surgery or still recovering from one in the last 2 weeks.

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I haven't had chemotherapy or chemoimmunotherapy in the last 4 weeks, except for allowed treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from registration to death from any cause or 5 years from time of enrollment, whichever occurs first

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from registration to death from any cause or 5 years from time of enrollment, whichever occurs first

This trial's timeline: 3 weeks for screening, Varies for treatment, and from registration to death from any cause or 5 years from time of enrollment, whichever occurs first for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival

Secondary study objectives

Incidence of toxicities

Overall survival

Side effects data

From 2015 Phase 3 trial • 3526 Patients • NCT00074581

Blood bilirubin increased

Blood phosphorus decreased

Abnormal loss of weight

Neutropenia

Neutrophil count decreased

Hypophosphataemia

Aspartate aminotransferase increased

Hyperbilirubinaemia

Malaria

Alanine aminotransferase increased

Anaemia

Pneumonia

Haemoglobin decreased

Dizziness

Blood albumin decreased

Hypertension

Diarrhoea

Blood sodium decreased

Dyslipidaemia

Abortion spontaneous

Completed suicide

Suicidal ideation

Thrombocytopenia

Deep vein thrombosis

Diarrhoea haemorrhagic

Gastroenteritis

Pelvic inflammatory disease

Pneumonia bacterial

Platelet count decreased

Transaminases increased

Abortion incomplete

Death

Hepatotoxicity

Urinary tract infection

Suicide attempt

100%

80%

60%

40%

20%

Study treatment Arm

Early-ART

Delayed-ART

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (lamivudine, chemoimmunotherapy)Experimental Treatment4 Interventions

INDUCTION: 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lamivudine

2006

Completed Phase 4

~8120

Etoposide

2010

Completed Phase 3

~2960