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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Progression Free Survival (PFS) Rate
Secondary outcome measures
Disease control rate (DCR)
Overall Survival Rate
Side effects data
From 2018 Phase 2 trial • 35 Patients • NCT0136059321%
Anemia
18%
Neutropenia
15%
Hypoalbuminemia
15%
White blood cell decreased ( leukopenia)
15%
Diarrhea
12%
Liver Dysfunction
9%
Hand-Foot
3%
Bleeding
3%
Stroke
3%
Abdominal Infection
3%
Ileus
3%
Mucositis
3%
Edema
3%
Dermatitis
3%
Platelet count decreased ( Thrombocytopenia)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gem + Xeloda + SBRT
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
~6670
Etoposide
2010
Completed Phase 3
~2440
Atezolizumab
2017
Completed Phase 3
~5860
Stereotactic Body Radiation Therapy (SBRT)
2018
Completed Phase 2
~740
Find a Location
Who is running the clinical trial?
Brian Henick, MDLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I have previously been treated with immune checkpoint inhibitors.My blood and organ tests meet the required health standards.I have high calcium levels in my blood that are causing symptoms.I am allergic to certain medications made in Chinese hamster ovary cells or ingredients in atezolizumab.I have had a bone marrow or organ transplant in the past.I have not received any treatment for small cell lung cancer.I haven't taken any immune-weakening drugs in the last 2 weeks.I have a cancer that can be measured by scans, besides the liver cancer being treated with SBRT.I have had treatment targeting my liver.I am 18 years old or older.I have provided a liver tumor sample before starting treatment.You have had serious allergic reactions to certain types of medication in the past.My brain cancer has not worsened after my last treatment.I have a liver tumor that is at least 1 cm big.I agree to not have sex or to use a condom, and not to donate sperm.I have had treatment for small cell lung cancer before.I have not had brain radiation in the last week.I am not on steroids for brain-related issues.I am fully active or restricted in physically strenuous activity but can do light work.My spinal cord compression hasn't been treated or stabilized for at least 1 week.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.I have had radiation for small cell lung cancer outside of my brain.My cancer has spread to the lining of my brain and spinal cord.I do not have any health conditions that would make it unsafe for me to take a new drug.I had brain metastases treated and currently have no symptoms.I haven't had major surgery in the last 28 days and don't expect any during the study.My liver disease is classified as moderate to severe.I haven't had cancer other than small cell lung cancer in the last 5 years.My small cell lung cancer diagnosis is confirmed by lab tests.You need to have a negative HIV test, with some special cases.I do not have any severe infections currently.I have active hepatitis B or C.I have active tuberculosis.You have a history of autoimmune diseases.I have a serious heart condition.You have had allergic reactions to carboplatin or etoposide in the past.I have brain metastases that are either active or not treated yet.I am willing to switch from denosumab to a bisphosphonate for the study.My cancer has spread only to the upper brain and cerebellum.I frequently need procedures to remove excess fluid from my chest or abdomen.I have treated my new, symptom-free brain metastases and meet all other criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: Chemotherapy+SBRT
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 there currently any individuals eligible to join this research project?
"Present data accessible on clinicaltrials.gov attests to the fact that this trial is recruiting participants - with first posting occuring on September 20th 2021 and most recent modification taking place April 7th 2022."
Answered by AI
What maladies have been successfully managed with Stereotactic Body Radiation Therapy (SBRT)?
"Stereotactic Body Radiation Therapy (SBRT) is a viable option for those dealing with recurrent conditions. Additionally, this therapeutic approach can target advanced cervical cancer, gestational trophoblastic disease and other advance directives."
Answered by AI
How many participants have been accepted for this research trial?
"Affirmative. Details displayed on clinicialtrials.gov verify that this research is actively searching for participants, having been posted on September 20th 2021 and edited most recently April 7th 2022. The study requires 18 individuals to be recruited from one medical centre."
Answered by AI
Has the FDA sanctioned Stereotactic Body Radiation Therapy (SBRT) for medicinal use?
"Although there is some evidence of Stereotactic Body Radiation Therapy (SBRT)'s safety, the absence of clinical data to affirm its efficacy resulted in a rating of 2 out 3."
Answered by AI
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