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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)
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
Study Summary
This trial is studying the effect of lamivudine, in combination with standard chemoimmunotherapy, on treating patients with small cell lung cancer that has spread to other parts of the body.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival
Secondary outcome measures
Incidence of toxicities
Overall survival
Side effects data
From 2015 Phase 3 trial • 3526 Patients • NCT000745818%
Blood bilirubin increased
8%
Blood phosphorus decreased
8%
Abnormal loss of weight
7%
Neutropenia
7%
Neutrophil count decreased
5%
Hypophosphataemia
4%
Aspartate aminotransferase increased
4%
Hyperbilirubinaemia
3%
Malaria
2%
Alanine aminotransferase increased
2%
Anaemia
2%
Pneumonia
2%
Haemoglobin decreased
2%
Dizziness
1%
Hypertension
1%
Blood albumin decreased
1%
Diarrhoea
1%
Blood sodium decreased
1%
Dyslipidaemia
1%
Abortion spontaneous
1%
Completed suicide
1%
Suicidal ideation
1%
Thrombocytopenia
1%
Deep vein thrombosis
1%
Diarrhoea haemorrhagic
1%
Gastroenteritis
1%
Pelvic inflammatory disease
1%
Pneumonia bacterial
1%
Platelet count decreased
1%
Transaminases increased
1%
Abortion incomplete
1%
Death
1%
Hepatotoxicity
1%
Urinary tract infection
1%
Suicide attempt
100%
80%
60%
40%
20%
0%
Study treatment Arm
Early-ART
Delayed-ART
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
Etoposide
2010
Completed Phase 3
~2440
Lamivudine
2006
Completed Phase 4
~8120
Atezolizumab
2017
Completed Phase 3
~5860
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,779 Total Patients Enrolled
Grace K DyPrincipal InvestigatorRoswell Park Cancer Institute
2 Previous Clinical Trials
17 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that weakens my immune system, such as HIV/AIDS.I haven't had a heart attack or blood clot in the last 6 months, and I don't have severe heart disease.I have not had an autoimmune disorder requiring immunosuppressants in the last 2 years.Your liver enzymes (ALT and AST) are not more than 3 times the upper limit of normal. If you have cancer that has spread to your liver, it's okay if your liver enzymes are not more than 5 times the upper limit of normal.I have had only one round of platinum-based chemotherapy for small cell lung cancer.I do not have any serious infections or uncontrolled conditions, including hepatitis.My lung cancer diagnosis was confirmed through lab tests.My cancer has spread to the lining of my brain and spinal cord.My cancer has spread beyond my lungs.I have small cell lung cancer and have had only one round of chemotherapy or chemoimmunotherapy.I have irregular heartbeats that are not well-managed.I have brain metastasis causing symptoms.I have had severe heart failure in the last 6 months.I haven't had major surgery or still recovering from one in the last 2 weeks.Your blood platelet count is at least 100 billion per liter.I can carry out all my self-care but cannot work.I am 18 years old or older.Your absolute neutrophil count is at least 1.5 billion per liter.My kidney function tests are within normal range.Your hemoglobin level is at least 9 grams per deciliter.I haven't had chemotherapy or chemoimmunotherapy in the last 4 weeks, except for allowed treatments.My last treatment with platinum was over a year ago and my small cell lung cancer did not worsen during that treatment.My cancer can be measured and tracked using specific criteria.Your bilirubin levels in your blood need to be within a certain range, unless you have a documented condition called Gilbert's syndrome, in which case slightly higher levels may be acceptable.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (lamivudine, chemoimmunotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what circumstances is Lamivudine usually recommended?
"Lamivudine is often prescribed to treat recurrent, as well as advance directives, advanced cervical cancer, and gestational trophoblastic disease."
Answered by AI
Are there unfilled slots available for prospective participants in this experiment?
"According to the clinicaltrials.gov webpage, this medical trial is still searching for participants; it was initiated on July 2nd 2021 with its most recent update being October 20th 2022."
Answered by AI
What earlier studies utilized Lamivudine as a therapeutic agent?
"Presently, Lamivudine is the subject of 1209 clinical studies with 332 trials in Phase 3. An abundance of research sites are exploring this medication, from Shanghai to 68270 other locations across the world."
Answered by AI
What is the danger-profile of Lamivudine treatments?
"Our team at Power has evaluated Lamivudine's safety as a 2 on their rating system. This judgement is based off the evidence presented in Phase 2 trials, which have offered some insight into its security but no confirmation of efficacy."
Answered by AI
How many participants are being recruited for this trial?
"Affirmative. Clinicaltrials.gov indicates that this medical investigation is recruiting now and was initially posted on July 2nd 2021 with the most recent update occuring October 20th 2022. The trial requires 28 test subjects to be sourced from 1 healthcare facility."
Answered by AI
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