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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

Must not have

Diagnosis of congenital long QT syndrome

Treatment, within 7 days prior to first dose of study drug, with medications that are known to prolong the QT interval and/or are associated with a risk of torsades de pointes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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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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.

Exclusion Criteria

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

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I have been diagnosed with congenital long QT syndrome.

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I haven't taken any heart-risk drugs in the last week.

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I have had a bone marrow or organ transplant in the past.

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I do not need frequent procedures to remove fluid from my chest or abdomen.

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I have been diagnosed with non-small cell lung cancer or a mix of non-small and small cell lung cancer.

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I am currently on antibiotics for an infection.

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I have been diagnosed with hepatitis B or C.

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I am HIV positive.

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I do not have serious heart conditions like recent heart attacks or severe heart disease.

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I haven't taken certain seizure medications in the last 7 days.

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I haven't taken warfarin in the last 7 days.

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I have high calcium levels in my blood that are not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Recommended phase II dose (RP2D)

Secondary study objectives

Duration of overall response

Incidence of safety and adverse events

Objective response rate (ORR)

+2 more

Other study objectives

AUC0-t of LB-100

AUC0-t of endothall

CL of LB-100

+8 more

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 (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

~5850

Carboplatin

2014

Completed Phase 3

~6120