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Alkylating agents
Durvalumab + Radiation for Small Cell Lung Cancer
Phase 2
Recruiting
Led By Christine Bestvina, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Body weight >30 kg
Patient is suitable to receive a platinum-based chemotherapy regimen as first line treatment for extensive stage small cell lung cancer
Must not have
Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
Active infection including tuberculosis, hepatitis B, hepatitis C, or HIV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
Summary
This trial will explore if combining radiation with durvalumab, carboplatin and etoposide can help treat extensive-stage small cell lung cancer. Participation lasts 48 months.
Who is the study for?
This trial is for adults over 18 with newly diagnosed extensive-stage small cell lung cancer that hasn't been treated yet. Participants must have a life expectancy of at least 12 weeks, be able to perform daily activities (ECOG status 0-2), and have tumors suitable for focused radiation. They should not be pregnant or breastfeeding, agree to use contraception, and cannot have had previous treatments like chemotherapy or certain immunotherapies for lung cancer.Check my eligibility
What is being tested?
The study tests if adding ablative radiation therapy to the FDA-approved combination of durvalumab (an immunotherapy drug), carboplatin, and etoposide can improve survival without cancer progression in patients with extensive-stage small cell lung cancer. The treatment's effectiveness will be monitored over approximately four years.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, fatigue, nausea from chemotherapy drugs, potential blood disorders due to bone marrow suppression by carboplatin and etoposide, as well as skin irritation or damage to nearby tissues from radiation therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh more than 30 kilograms.
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I am eligible for platinum-based chemotherapy as my first treatment for extensive small cell lung cancer.
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I can care for myself and am up and about more than 50% of my waking hours.
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My lung cancer has spread to other parts of my body.
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I have a tumor that can be measured and is suitable for targeted radiation therapy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any serious ongoing illnesses that could affect my participation in the study.
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I do not have active infections like TB, hepatitis B, C, or HIV.
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I have a condition related to my cancer that affects other parts of my body and requires strong medication.
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I have been treated with medications targeting PD-1/PD-L1 or CTLA4.
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I haven't had extensive radiation to my bone marrow or wide field radiation in the last 4 weeks.
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I haven't taken immunosuppressive drugs in the last 14 days.
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I've had significant radiation therapy to the area that will be treated in this trial.
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I have had treatments like chemotherapy or radiation for small cell lung cancer.
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I have or had an autoimmune or inflammatory disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
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 of Participant Until Disease Progression or Death
Secondary outcome measures
Overall Survival Rate of Participants After Treatment with Chemotherapy, Durvalumab and Ablative Radiation
Progression Free Survival at 12 Months
Rate of Participants with Grade 3/4 Adverse Events After 3 Months According to the Common Terminology Criteria for Adverse Events
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Participants With Extensive Small Cell Lung Cancer (All Participants)Experimental Treatment4 Interventions
This arm will involve all participants in the study who have extensive small cell lung cancer that has not responded to previous treatments. All participants will receive the same treatment of study drugs and radiation treatment in "cycles" (a specific window of time).
You will receive up to four 21-day cycles of chemotherapy using carboplatin, etoposide and durvalumab (immunotherapy) as part of a standard care treatment plan recommended by your doctor. These drugs will be combined with ablative radiation treatment during the second cycle of chemotherapy.
After completing these four cycles of chemotherapy (with radiation treatment added in cycle 2), you will continue to receive a fixed dose of durvalumab until your cancer progresses, you experience serious side effects, you decide to no longer be part of the study or the study doctor request to take you off the study for medical reasons.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3840
Carboplatin
2014
Completed Phase 3
~6670
Etoposide
2010
Completed Phase 3
~2440
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,018 Previous Clinical Trials
734,566 Total Patients Enrolled
Christine Bestvina, MDPrincipal InvestigatorUniversity of Chicago - Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I weigh more than 30 kilograms.I am eligible for platinum-based chemotherapy as my first treatment for extensive small cell lung cancer.I am not pregnant or breastfeeding and willing to use birth control during and up to 90 days after treatment.You have had an organ transplant from someone else.I don't have lasting side effects from cancer treatment, except for hair loss or skin changes.I haven't had major surgery in the last 28 days, except for minor procedures to relieve symptoms.You are expected to live for at least 12 more weeks.I do not have any serious ongoing illnesses that could affect my participation in the study.I can care for myself and am up and about more than 50% of my waking hours.I do not have active infections like TB, hepatitis B, C, or HIV.I agree to use birth control during and for 4 months after the study.I had cancer before, but it was treated over 5 years ago and is not likely to come back.I am using hormone therapy for reasons other than cancer.I have not received a live vaccine in the last 30 days.I can sign and follow the study's consent form and rules.I am willing and able to follow the study's treatment and visit schedule.I have a condition related to my cancer that affects other parts of my body and requires strong medication.I am using two birth control methods or am not having sex to join this study.I have been treated with medications targeting PD-1/PD-L1 or CTLA4.My brain metastases are stable without needing steroids or seizure medicine for 2 weeks.My lung cancer has spread to other parts of my body.I haven't had extensive radiation to my bone marrow or wide field radiation in the last 4 weeks.You have a history of a weakened immune system that is currently active.I haven't taken immunosuppressive drugs in the last 14 days.I am older than 18 years.I've had significant radiation therapy to the area that will be treated in this trial.I have had treatments like chemotherapy or radiation for small cell lung cancer.My blood tests show my organs and bone marrow are working well.I have or had an autoimmune or inflammatory disorder.I have a tumor that can be measured and is suitable for targeted radiation therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Participants With Extensive Small Cell Lung Cancer (All Participants)
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.
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