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Monoclonal Antibodies
Durvalumab + Lurbinectedin for Small Cell Lung Cancer
Phase 2
Recruiting
Led By Konstantinos Leventakos
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prior therapy must have been an etoposide platinum doublet combined with PD-1 or PD-L1 inhibitor
Histological or cytological confirmation of small cell lung cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing the effects of two different combinations of drugs on patients with small cell lung cancer that has come back or has not responded to previous treatment.
Who is the study for?
This trial is for adults with small cell lung cancer that has returned or didn't respond to chemo and immunotherapy. Participants must have had only one prior treatment regimen, be in good health otherwise, and willing to use contraception. They can't join if they've had severe reactions to similar drugs, active infections or other cancers, certain heart conditions, or are pregnant/nursing.Check my eligibility
What is being tested?
The trial tests Durvalumab (a monoclonal antibody) combined with Lurbinectedin (an alkylating agent) on patients with relapsed/refractory extensive stage small cell lung cancer. It aims to see if this combination helps control the disease better and improves survival rates.See study design
What are the potential side effects?
Durvalumab may cause immune-related side effects like inflammation of organs; Lurbinectedin could lead to fatigue, nausea, blood count changes. Both drugs might increase infection risk and cause allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My previous treatment included etoposide, platinum, and a PD-1 or PD-L1 inhibitor.
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My lung cancer diagnosis was confirmed through lab tests.
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I am fully active or can carry out light work.
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I am 18 years old or older.
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I weigh more than 30 kilograms.
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My cancer returned or worsened after one chemotherapy and PD-1/PD-L1 treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
6-month progression-free survival rate (Group 2)
6-month survival rate (Group 1)
Secondary outcome measures
Incidence of adverse events (AEs)
Overall survival (OS)
Progression-free survival (PFS)
+1 moreSide effects data
From 2022 Phase 2 trial • 80 Patients • NCT0301512965%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (durvalumab, lurbinectedin)Experimental Treatment2 Interventions
Patients receive durvalumab IV over 60 minutes on day 1 and lurbinectedin IV over 60 minutes on day 1. Cycles 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
Durvalumab
2017
Completed Phase 2
~3870
Lurbinectedin
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,799 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,209 Previous Clinical Trials
3,767,028 Total Patients Enrolled
Konstantinos LeventakosPrincipal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your bilirubin levels must be within a certain range, and this will be checked within two weeks before you join the study.Your platelet count needs to be at least 100,000 per cubic millimeter.I have not had a heart attack in the last 6 months and do not need ongoing therapy for severe heart rhythm problems.My cancer returned more than 90 days after my last treatment, making it platinum-sensitive.I have not had radiation therapy in the last 3 weeks.I haven't taken immunosuppressive drugs in the last 14 days.I haven't had chemotherapy or targeted therapy in the last 3 weeks.Your hemoglobin level is at least 9.0 grams per deciliter.I have not had surgery in the last 28 days.Your albumin level in your blood is at least 2.5 mg/dL, based on a test taken within the last 15 days.My kidney function tests are within the required range.I have not used any experimental treatments or devices in the last 14 days.My previous treatment included etoposide, platinum, and a PD-1 or PD-L1 inhibitor.Your white blood cell count needs to be at least 1500 per cubic millimeter.Your liver enzymes (ALT and AST) are not more than 2.5 times the upper limit of normal, or not more than 5 times the upper limit of normal if you have liver involvement.I do not have any serious ongoing illnesses that could interfere with the study.I have an active HIV infection.I stopped a cancer treatment because it caused me severe side effects.My lung cancer diagnosis was confirmed through lab tests.You are expected to live for at least 12 more weeks.I have had severe side effects from immunotherapy, especially affecting my nerves or eyes.I am of childbearing age or can father a child and do not plan to use birth control.I have not had any other cancer within the last 6 months.My condition may be responsive or not to platinum-based chemotherapy.You have a disease that can be measured or seen.I am currently on medication for an autoimmune disease.I have active cancer spread to my brain or spinal cord.My cancer has spread to the lining of my brain and spinal cord.I will use birth control during and for 4 months after treatment.I have not received a live vaccine in the last 30 days.You are allergic to durvalumab or any of the substances it contains.I am not on any experimental drugs for my cancer.I am willing to give tissue samples for research.Women who can get pregnant must have a negative pregnancy test within 7 days before joining the study.I am fully active or can carry out light work.I am 18 years old or older.I weigh more than 30 kilograms.My cancer returned or worsened after one chemotherapy and PD-1/PD-L1 treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (durvalumab, lurbinectedin)
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.
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.
How many subjects have participated in this experiment?
"Affirmative. Clinicaltrials.gov states that this medical research is actively seeking contributors, having first been uploaded on December 4th 2020 and last updated on November 1st 2022. There are 106 places open at one particular site for enrolment in the study."
Answered by AI
Is enrollment open for this experiment?
"As depicted on clinicaltrials.gov, this medical research is actively seeking volunteers to join the trial which was originally posted on December 4th 2020 and received its latest update November 1st 2022."
Answered by AI
What symptoms does Topotecan Hydrochloride typically treat?
"Topotecan Hydrochloride is typically used for the treatment of acute myelocytic leukemia. It can also prove effective in mitigating sarcoma, refractory neuroblastoma, and other forms of central nervous system malignancies."
Answered by AI
What is the primary aim of this exploration?
"This clinical trial aims to evaluate the 6-month survival rate and further measure Overall Survival, Progression-free Survival, as well as Incidence of Adverse Events. To report this data, Kaplan Meier's method will be employed and CTCAE version 5.0 will be used for AE monitoring. Additionally, 90% confidence intervals are expected to accompany each treatment group separately."
Answered by AI
Have any other research projects focused on the utilization of Topotecan Hydrochloride?
"As of now, 392 studies are currently underway for Topotecan Hydrochloride with 69 trials in the final stage. Although most locations conducting these tests are in Houston, Texas, there exists a total of 15739 sites where such clinical research is conducted."
Answered by AI
How efficacious is Topotecan Hydrochloride in terms of safety for human use?
"Our team at Power assigned the safety of Topotecan Hydrochloride a rating of 2, as there has been preliminary research conducted to validate its security but no clinical trials have yet established efficacy."
Answered by AI
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