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PD-L1 Inhibitor
LB-100 + Chemotherapy + Immunotherapy for Small Cell Lung Cancer
Phase 1
Recruiting
Led By Ravi Salgia
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed extensive-stage disease small cell lung carcinoma per the Veterans Administration Lung Study Group (VALG) staging system
For women: Must be surgically sterile (surgical procedure: bilateral tubal ligation), post-menopausal (at least 12 consecutive months of amenorrhea) or have a negative pregnancy test. Women of childbearing potential must be compliant with a medically approved contraceptive regimen (intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test within 14 days before study drug treatment and must not be breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is studying the side effects and best dose of LB-100 when given with carboplatin, etoposide, and atezolizumab to treat patients with extensive-stage small cell lung cancer that has not been treated before.
Who is the study for?
This trial is for adults with untreated extensive-stage small cell lung cancer. Participants must have proper liver, kidney, and blood function, not be pregnant or breastfeeding, agree to use contraception if of childbearing potential, and have no prior treatments for SCLC. They should also have a life expectancy of at least 12 weeks and an ECOG performance status of 0-2.Check my eligibility
What is being tested?
The study tests the combination of LB-100 with standard chemotherapy drugs (carboplatin and etoposide) plus immunotherapy drug Atezolizumab. It aims to find the best dose of LB-100 that enhances the effectiveness of these drugs in killing tumor cells by blocking a protein called PP2A.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in organs or infusion-related reactions; typical chemotherapy side effects like nausea, fatigue, hair loss; blood disorders; increased risk of infections due to lowered immunity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is confirmed to be extensive-stage small cell type.
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I am a woman not able to have children, not pregnant, and not breastfeeding.
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I agree to use contraception or remain abstinent to prevent pregnancy during and for 6 months after the study.
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My kidney function, measured by creatinine clearance, is good.
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I haven't had any drug treatments for small cell lung cancer.
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I can take care of myself and perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended phase II dose (RP2D)
Secondary outcome measures
Duration of overall response
Incidence of safety and adverse events
Objective response rate (ORR)
+2 moreOther outcome measures
AUC0-t of LB-100
AUC0-t of endothall
CL of LB-100
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (LB-100, carboplatin, etoposide, atezolizumab)Experimental Treatment4 Interventions
INDUCTION: Patients receive LB-100 IV over 15 minutes on days 1 and 3, atezolizumab IV over 30-60 minutes on day 1, carboplatin IV over 30-60 minutes on day 1, and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: After completion of induction therapy, patients receive LB-100 IV over 15 minutes on days 1 and 3 and atezolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Carboplatin
2014
Completed Phase 3
~6670
Etoposide
2010
Completed Phase 3
~2440
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,439 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,620 Total Patients Enrolled
Ravi SalgiaPrincipal InvestigatorCity of Hope Medical Center
4 Previous Clinical Trials
120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with congenital long QT syndrome.I haven't taken any kidney-damaging drugs in the last week.My lung cancer is confirmed to be extensive-stage small cell type.Your bilirubin levels must be within a certain range to be eligible.I have a history of lung scarring or inflammation but not due to radiation.I haven't taken any heart-risk drugs in the last week.I am a woman not able to have children, not pregnant, and not breastfeeding.I have had a bone marrow or organ transplant in the past.Your heart's electrical activity is too high on multiple EKG tests.I haven't taken strong P-glycoprotein inhibitors in the last 7 days.You are expected to live for at least 12 more weeks.I agree to use contraception or remain abstinent to prevent pregnancy during and for 6 months after the study.Your liver enzyme levels need to be within a certain range, unless you have liver tumors.You must have at least 100 platelets per microliter of blood.My kidney function, measured by creatinine clearance, is good.I had brain metastases but am now symptom-free, off steroids for 1 week, and finished radiation 2 weeks ago.I do not need frequent procedures to remove fluid from my chest or abdomen.I have not had cancer before, except for specific types or those treated over 5 years ago without coming back.I have been diagnosed with non-small cell lung cancer or a mix of non-small and small cell lung cancer.I have not received a live vaccine in the last 28 days.I haven't had any drug treatments for small cell lung cancer.I am currently on antibiotics for an infection.I haven't taken any drugs that affect liver enzymes in the last week.Your absolute neutrophil count is equal to or greater than 1.5 x 10/L.Your hemoglobin level needs to be at least 9 grams per deciliter.I have been diagnosed with hepatitis B or C.I am HIV positive.I do not have serious heart conditions like recent heart attacks or severe heart disease.I haven't taken certain seizure medications in the last 7 days.I haven't taken warfarin in the last 7 days.I have an autoimmune disease but don't need strong medication for it.I am not on high-dose steroids or immunosuppressants, except for specific allowed conditions.I have high calcium levels in my blood that are not under control.I can take care of myself and perform daily activities.You have a tumor that can be measured and evaluated using specific guidelines called RECIST.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (LB-100, carboplatin, etoposide, atezolizumab)
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.
Are participants currently being recruited for this clinical trial?
"Affirmative, the clinical trial is currently on the hunt for participants. This medical trial was initially posted on May 28th 2021 and has been kept up to date as of March 9th 2022. The study seeks 21 individuals across 1 site."
Answered by AI
What therapeutic benefits have been observed with the application of Protein Phosphatase 2A Inhibitor LB-100?
"Protein Phosphatase 2A Inhibitor LB-100 is a frequently used treatment for recurrent cases. It has also demonstrated effectiveness in addressing advanced directives, gestational trophoblastic disease and the management of certain forms of cervical cancer."
Answered by AI
To what extent is the cohort size of this research study?
"Affirmative. Clinicaltrials.gov contains evidence that on May 28th 2021, this trial began looking for participants and the most recent update was made on March 9th 2022. The study requires 21 individuals at a single clinic to complete it's research objectives."
Answered by AI
Is LB-100, a Protein Phosphatase 2A Inhibitor, formally sanctioned by the FDA?
"Given the limited evidence pertaining to Protein Phosphatase 2A Inhibitor LB-100's safety and efficacy, this compound was assigned a score of 1."
Answered by AI
Has research been conducted into the efficacy of Protein Phosphatase 2A Inhibitor LB-100 in a clinical setting?
"At present, 318 clinical trials for Protein Phosphatase 2A Inhibitor LB-100 are in their third phase with a total of 1175 live studies. Shanghai is the leading city hosting tests related to this medication; however there are 68,053 locations worldwide conducting investigations on its effectiveness and safety."
Answered by AI
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