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

ConditionExtensive Stage Lung Small Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoswell Park Cancer Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Atezolizumab

    Biological/Vaccine

    Given IV

  • Carboplatin

    Drug

    Given IV

  • Etoposide

    Drug

    Given IV

  • Lamivudine

    Drug

    Given PO

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Treatment (lamivudine, chemoimmunotherapy)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

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.

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

Secondary outcomes

1

Overall survival

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

Time frame
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.

Time frame
Up to 30 days after the end of all treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Roswell Park Cancer Institute

Lead sponsor

Source ClinicalTrials.gov
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