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Can an HIV drug help beat lung cancer? new trial aims to stop resistance

NCT ID NCT04696575

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding lamivudine, an antiviral drug, to standard chemotherapy and immunotherapy can prevent or delay drug resistance in people with extensive-stage small cell lung cancer. About 28 adults will receive the combination treatment. The goal is to see if this approach improves how long the cancer stays under control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 28 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2021

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Roswell Park Cancer Institute

    RECRUITING

    Buffalo, New York, 14263, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.