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Chemotherapy
Chemo-Immunotherapy + Radiotherapy for Stage IV Small Cell Lung Cancer
Phase 2
Waitlist Available
Led By Ashish Saxena, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults ≥ 18 years old
Pathological diagnosis of SCLC from biopsy (core biopsy or fine needle aspiration); mixed-histology (NSCLC and SCLC) allowed
Timeline
Screening 2 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is for people with Stage IV small cell lung cancer who haven't started treatment yet. They'll get radiation therapy for 5 days, then standard chemo-immunotherapy for 4 cycles. They may keep getting durvalumab until their disease progresses.
Who is the study for?
This trial is for adults over 18 with untreated Stage IV small cell lung cancer. Participants must weigh more than 30kg, have a good performance status (able to carry out daily activities), and not have had prior immunotherapy or treatment for their lung cancer. They should be able to measure at least one lesion, have no major organ dysfunction, and women must not be pregnant and use birth control.Check my eligibility
What is being tested?
The study tests radiation therapy followed by chemo-immunotherapy combining etoposide with either carboplatin or cisplatin plus durvalumab for four cycles. Patients may continue durvalumab post-cycles until disease progression. The goal is to assess the effectiveness of this combined treatment approach.See study design
What are the potential side effects?
Possible side effects include reactions related to infusion treatments, fatigue, blood disorders like low platelet count or anemia, potential liver enzyme elevations indicating liver stress, kidney function changes due to creatinine clearance alterations, and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My cancer diagnosis came from a biopsy and is small cell lung cancer, possibly mixed with non-small cell lung cancer.
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My small cell lung cancer is at an advanced stage, not suitable for radiation due to its size or spread.
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My body weight is over 30kg.
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I have a tumor that can be measured and tracked over time.
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I have never received immunotherapy treatments.
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My white blood cell count is high enough without medication.
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My liver enzymes are within the required range for my cancer condition.
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My kidney function is good enough for certain chemotherapy drugs.
Timeline
Screening ~ 2 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months1 visit
Screening ~ 2 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of multi-site, non-ablative radiation to standard systemic therapy for patients with extensive-stage small cell lung, as measured by a change in disease response
Number of toxicities Grade 3 or above related to therapy
Secondary outcome measures
Objective response rate, determined by disease response rate defined by the RECIST 1.1 criteria
Overall survival, defined as the time from first study treatment to the time of death from any cause
Pattern of disease progression, defined by the progression in radiated lesions vs. non-radiated lesions and the rates of new lesions as determined by RECIST 1.1
Other outcome measures
Evaluation of inflammatory protein composition in those that respond to treatment vs those that do not respond
Evaluation of the circulating immune cell in those that respond to treatment vs those that do not respond
Evaluation of the tumor-immune microenvironment in those that respond to treatment vs those that do not respond
Side effects data
From 2008 Phase 2 trial • 20 Patients • NCT0035014215%
ulcer
10%
vomiting
5%
Perforation
5%
pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
SBRT With Gem
Trial Design
1Treatment groups
Experimental Treatment
Group I: Radiation + Chemo-ImmunotherapyExperimental Treatment5 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved
Stereotactic Body Radiotherapy
2017
Completed Phase 2
~220
Carboplatin
FDA approved
Cisplatin
FDA approved
Etoposide
FDA approved
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,486 Total Patients Enrolled
Ashish Saxena, MDPrincipal InvestigatorWeill Medical College of Cornell University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an active autoimmune or inflammatory disorder that is not under control.I cannot undergo radiation therapy due to health reasons.I have had radiation therapy at the same site where SBRT is proposed.I am not on any cancer treatments except for hormone therapy for non-cancer reasons, bisphosphonates, or RANKL inhibitors.I had early-stage cancer that was treated, and now there's no sign of it.You have received an organ transplant from someone else in the past.I haven't had major surgery in the last 28 days, except for minor procedures to relieve symptoms.You have celiac disease but can control it with diet alone.I haven't had any live vaccines in the last 30 days.My small cell lung cancer is at an advanced stage, not suitable for radiation due to its size or spread.I haven't had radiation therapy in the last 3 years, except for brain metastases from small cell lung cancer.My organs are functioning well.My white blood cell count is high enough without medication.I am receiving treatment for an autoimmune condition linked to my cancer.You are expected to live for at least 12 weeks from the beginning of the treatment.I was treated for early-stage small cell lung cancer with chemo and radiation at the same time.I cannot stay still for radiation treatment.My cancer diagnosis came from a biopsy and is small cell lung cancer, possibly mixed with non-small cell lung cancer.I haven't had active disease in the last 5 years and have consulted with a specialist.I do not have any serious ongoing illnesses that my doctor is not able to control.I am 18 years old or older.I do not have an active infection like TB, HBV, HCV, or HIV.My kidney function, based on a calculation involving my age, weight, and creatinine levels, is adequate.I have nerve damage that affects my daily activities.My thyroid condition is stable with medication.I cannot receive platinum-based chemotherapy due to health reasons.My cancer was treated over 3 years ago, and it's unlikely to come back.I had skin cancer (not melanoma) treated and currently show no signs of it.I am using steroids that are inhaled, nasal, topical, or injected into joints.I am allergic to durvalumab, etoposide, carboplatin, cisplatin, or their ingredients.I haven't taken immunosuppressive drugs in the last 14 days.I am taking a low dose of steroids, not more than 10 mg/day of prednisone or its equivalent.You have a skin condition called vitiligo or hair loss condition called alopecia.I have had cancer before, but it was a different type than my current diagnosis.I have received treatment for Small Cell Lung Cancer before.I have never received immunotherapy treatments.My body weight is over 30kg.I am mostly active but may have some limitations due to my small cell lung cancer.I am post-menopausal or not pregnant if of childbearing age.I am under 50 and considered post-menopausal due to no periods for 12 months, hormone levels, or surgery.I have a tumor that can be measured and tracked over time.My kidney function, based on a formula considering my age, weight, and creatinine levels, is adequate.I am a woman over 50 and have not had a period for more than a year due to menopause or surgery.I have a lasting side effect that won't worsen with durvalumab, as confirmed by a study doctor.I don't have lasting side effects from cancer treatment, except for hair loss or skin changes.I am taking steroids only as a premedication for allergies or before chemotherapy.My liver enzymes are within the required range for my cancer condition.My kidney function is good enough for certain chemotherapy drugs.I have brain metastases but don't need high-dose steroids or have been treated.I am not pregnant, breastfeeding, and willing to use birth control during and up to 90 days after treatment.I have a skin condition that doesn't need treatment with pills or injections.
Research Study Groups:
This trial has the following groups:- Group 1: Radiation + Chemo-Immunotherapy
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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 2 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 3 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 12 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.
Is the enrollment period for this research study still open?
"Indeed, according to clinicaltrials.gov the trial is actively recruiting for 42 participants across 3 sites since its initial release on July 12th 2021 and latest edits made in late July 2022."
Answered by AI
How many individuals are actively participating in this experiment?
"Affirmative. According to information provided on clinicaltrials.gov, this trial began recruitment of participants on July 12th 2021 and is still recruiting as of the last update on July 28th 2022. A total 42 people will be admitted at 3 medical centres."
Answered by AI
In what ways has Stereotactic Body Radiotherapy been demonstrated to be beneficial?
"Stereotactic Body Radiotherapy is a common course of treatment for hodgkin disease and has also been known to be effective in treating malignant pleural mesothelioma, advanced head and neck cancer, as well as other advance directives."
Answered by AI
Have there been any other investigations into the efficacy of Stereotactic Body Radiotherapy?
"At the present moment, there are 1535 ongoing trials involving Stereotactic Body Radiotherapy with 442 of these in Phase 3. Though most of them are based in Shanghai, a total 79373 sites globally have begun conducting research on this treatment modality."
Answered by AI
What potential adverse effects are associated with Stereotactic Body Radiotherapy?
"The safety of Stereotactic Body Radiotherapy was rated a 2, which indicates that there has been some data substantiating its security but none vouching for its effectiveness."
Answered by AI
Who else is applying?
What site did they apply to?
New York-Presbyterian Brooklyn Methodist Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
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