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DNA Transcription Inhibitor
Lurbinectedin + Radiotherapy for Small Cell Lung Cancer
Phase 1
Recruiting
Led By Kristin Higgins, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status =< 3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial is testing whether it's safe to use two cancer treatments at the same time to treat small cell lung cancer.
Who is the study for?
Adults with extensive stage small cell lung cancer that has spread and grown after chemotherapy can join this trial. They must have proper liver, blood, and bone marrow function, not be pregnant or breastfeeding, agree to use contraception, and have an ECOG performance status of 3 or less (which means they are capable of limited self-care).
What is being tested?
The trial is testing the safety of combining lurbinectedin (a drug that disrupts cancer cell DNA) with palliative radiotherapy in patients whose lung cancer has metastasized. The goal is to see if using them together improves effectiveness without increasing side effects.
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, fatigue, hair loss, increased risk of infection due to low blood counts; and for radiation therapy like skin irritation at the treatment site and fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I can take care of myself but can't do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events of palliative radio therapy (RT) with lurbinectedin
Secondary study objectives
Overall survival (OS)
Pain response rates
Patient-reported toxicity
+3 moreOther study objectives
Hematologic toxicity rate
Side effects data
From undefined Phase 1 trial • 2 Patients • NCT0231982450%
shortness of breath
50%
cough
50%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Radiation and NY-ESO-1-specific T Cells)
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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: Treatment (lurbinectedin and palliative radiation therapy)Experimental Treatment2 Interventions
Patients undergo palliative RT over 5 or 10 treatment fractions at the discretion of the treating physician daily for 21 days. Patients also receive lurbinectedin IV over 1 hour on day 1 of each cycle. Cycles of lurbinectedin repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lurbinectedin
FDA approved
Palliative Radiation Therapy
2015
Completed Phase 1
~80
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,920 Previous Clinical Trials
41,017,104 Total Patients Enrolled
Jazz PharmaceuticalsIndustry Sponsor
249 Previous Clinical Trials
34,818 Total Patients Enrolled
Emory UniversityLead Sponsor
1,697 Previous Clinical Trials
2,603,896 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand my cancer diagnosis and the risks and benefits of the study.I am not pregnant and can prove it with a test before starting treatment.I agree to use birth control during and after the study as required.I finished all my cancer treatments except lurbinectedin 3 weeks ago.I had radiation therapy, but my current cancer treatment area is not close to previously treated critical areas.I am willing and able to follow the study's schedule and procedures.Your hemoglobin level is higher than 7.0 grams per deciliter.I have brain metastases and take less than 10 mg of dexamethasone daily.I have small cell lung cancer and am eligible for or receiving lurbinectedin after my first treatment didn’t work.You need to have at least 100,000 platelets per cubic millimeter of blood.I am 18 years old or older.Your total bilirubin level should be less than 1.5 times the upper limit of normal.My cancer has spread to my bones or organs, confirmed by a scan within the last 3 months.I can take care of myself but can't do heavy physical work.You need to have a certain level of a type of white blood cell called neutrophils in your blood.Your liver enzymes (AST/ALT) are not more than 3 times the upper limit of normal (or not more than 5 times if you have liver involvement).Your alkaline phosphatase levels are not too high, unless you have liver or bone metastases, in which case they can be a little higher.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (lurbinectedin and palliative radiation therapy)
Awards:
This trial has 2 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.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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