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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
Study 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.
Select...
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.
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
~3870
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
1,004 Previous Clinical Trials
819,728 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for the trial still open?
"As per the information on clinicaltrials.gov, this research is looking for volunteers and has been in operation since August 19th of 2022 with a recent update occurring on February 14th 2023."
Answered by AI
Has the application for Participants With Extensive Small Cell Lung Cancer (All Participants) been accepted by the FDA?
"Our collective sentiment at Power is that Participants With Extensive Small cell lung cancer (All Participants) have the safety rating of 2, as it has been tested in Phase 2 clinical trials and only preliminary evidence for its efficacy exists."
Answered by AI
Have any experiments been conducted that included patients diagnosed with extensive small cell lung cancer?
"At present, 1091 clinical trials for Participants With Extensive Small cell lung cancer (All Participants) are live with 293 of those trials in the most advanced phase. Although a number of these studies can be located in Orlando, Florida, there is an expansive network of 58978 research centres researching this disease across the world."
Answered by AI
What health concerns can be addressed by Participants With Extensive Small Cell Lung Cancer (All Participants)?
"Patients with Extensive Small cell lung cancer (All Participants) often receive this medication to address recurrent cancers. It is also used off-label for advanced cervical cancer, gestational trophoblastic disease and other medical concerns."
Answered by AI
What is the current enrollment number for this clinical trial?
"Affirmative. Clinicaltrials.gov attests that this research study, which was initially posted on August 19th 2022, is presently recruiting individuals for participation. 49 people are needed to be enrolled from a solitary medical location."
Answered by AI
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