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PD-L1 Inhibitor

Radiation + Chemo-immunotherapy for Small Cell Lung Cancer

Phase 2

Recruiting

Research Sponsored by Brian Henick, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate hematologic and end organ function, defined by specific laboratory results

No prior treatment for ES-SCLC

Must not have

Women who are pregnant, lactating, or intending to become pregnant during the study

Prior treatment with immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1therapeutic antibodies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding radiation to the standard chemo-immunotherapy treatment for extensive stage small cell lung cancer that has spread to the liver can improve responses in this patient population.

Who is the study for?

This trial is for adults with extensive stage small cell lung cancer (ES-SCLC) that has spread to the liver. They should not have had previous treatments for ES-SCLC, must be in good physical condition (ECOG 0 or 1), and cannot be on steroids for brain metastases. Participants need at least one liver tumor of a certain size and must provide a tissue sample before treatment starts. Women who can bear children and men must agree to use contraception.

What is being tested?

The study tests if adding radiation therapy targeting liver tumors improves outcomes when combined with standard chemo-immunotherapy (carboplatin, etoposide, atezolizumab) in patients with ES-SCLC that has spread to the liver. All participants will receive both chemo-immunotherapy and stereotactic body radiation therapy.

What are the potential side effects?

Possible side effects include reactions related to chemotherapy such as nausea, fatigue, hair loss; immunotherapy may cause immune-related issues like rash or colitis; radiation could lead to localized pain or changes in liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood and organ tests meet the required health standards.

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I have not received any treatment for small cell lung cancer.

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I have a cancer that can be measured by scans, besides the liver cancer being treated with SBRT.

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I am 18 years old or older.

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I have provided a liver tumor sample before starting treatment.

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My brain cancer has not worsened after my last treatment.

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I have a liver tumor that is at least 1 cm big.

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I agree to not have sex or to use a condom, and not to donate sperm.

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I am not on steroids for brain-related issues.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My small cell lung cancer diagnosis is confirmed by lab tests.

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My cancer has spread only to the upper brain and cerebellum.

Exclusion Criteria

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

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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I have previously been treated with immune checkpoint inhibitors.

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I have high calcium levels in my blood that are causing symptoms.

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I am allergic to certain medications made in Chinese hamster ovary cells or ingredients in atezolizumab.

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

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I have had treatment targeting my liver.

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I have had treatment for small cell lung cancer before.

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My spinal cord compression hasn't been treated or stabilized for at least 1 week.

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I have had radiation for small cell lung cancer outside of my brain.

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My cancer has spread to the lining of my brain and spinal cord.

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I haven't had major surgery in the last 28 days and don't expect any during the study.

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My liver disease is classified as moderate to severe.

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I do not have any severe infections currently.

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I have active hepatitis B or C.

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I have active tuberculosis.

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I have a serious heart condition.

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I have brain metastases that are either active or not treated yet.

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I am willing to switch from denosumab to a bisphosphonate for the study.

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I frequently need procedures to remove excess fluid from my chest or abdomen.

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

Progression Free Survival (PFS) Rate

Secondary study objectives

Disease control rate (DCR)

Overall Survival Rate

Side effects data

From 2018 Phase 2 trial • 35 Patients • NCT01360593

21%

Anemia

18%

Neutropenia

15%

Hypoalbuminemia

15%

White blood cell decreased ( leukopenia)

15%

Diarrhea

12%

Liver Dysfunction

Hand-Foot

Bleeding

Stroke

Abdominal Infection

Ileus

Mucositis

Edema

Dermatitis

Platelet count decreased ( Thrombocytopenia)

100%

80%

60%

40%

20%

Study treatment Arm

Gem + Xeloda + SBRT

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: Experimental: Chemotherapy+SBRTExperimental Treatment4 Interventions

Addition of SBRT, directed at liver metastases, to standard of care (SOC) treatment atezolizumab+chemotherapy in SCLC. All patients must undergo a mandatory biopsy of a liver lesion prior to chemotherapy initiation. Cycle 1 of chemoimmunotherapy will be administered as per standard of care, with radiation planning to be done subsequently in anticipation of liver-directed SBRT.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Etoposide

2010

Completed Phase 3

~2960