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Monoclonal Antibodies
Durvalumab + Lurbinectedin for Small Cell Lung Cancer
Phase 2
Recruiting
Led By Konstantinos Leventakos, M.D.
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
Must not have
History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Chemotherapy or targeted small molecule therapy < 21 days prior to registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial studies the effects of two drugs, durvalumab and lurbinectedin, on patients with advanced small cell lung cancer that has returned or not responded to previous treatments. Durvalumab boosts the immune system to fight cancer, and lurbinectedin stops cancer cells from growing. The goal is to see if this combination can help patients live longer without their cancer getting worse.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had a heart attack in the last 6 months and do not need ongoing therapy for severe heart rhythm problems.
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I haven't had chemotherapy or targeted therapy in the last 3 weeks.
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I do not have any serious ongoing illnesses that could interfere with the study.
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I have an active HIV infection.
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I stopped a cancer treatment because it caused me severe side effects.
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I have had severe side effects from immunotherapy, especially affecting my nerves or eyes.
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I am of childbearing age or can father a child and do not plan to use birth control.
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I have not had any other cancer within the last 6 months.
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I am currently on medication for an autoimmune disease.
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I have active cancer spread to my brain or spinal cord.
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My cancer has spread to the lining of my brain and spinal cord.
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I have not received a live vaccine in the last 30 days.
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I am not on any experimental drugs for my cancer.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
6-month progression-free survival rate (Group 2)
6-month survival rate (Group 1)
Secondary study objectives
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%
Anorexia
30%
Constipation
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Cough
15%
Abdominal Pain
15%
Back pain
15%
Increased Urinary Frequency
15%
Weight gain
13%
Arthralgia
10%
Dizziness
10%
Anxiety
10%
Bladder infection
10%
Nasal congestion
10%
Vaginal discharge
8%
Colitis
8%
Dry mouth
8%
Dry skin
8%
Fever
8%
Anal pain
8%
Edema limbs
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Small intestinal obstruction
8%
Thromboembolic event
8%
Urinary frequency
8%
Urinary tract pain
5%
Confusion
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Anemia
5%
Ascites
5%
Gastroesophageal reflux disease
5%
Hypomagnesemia
5%
Lymphedema
5%
Memory impairment
5%
Mucositis oral
5%
Pneumonitis
5%
Rash acneiform
5%
Sinus bradycardia
5%
Upper respiratory infection
5%
Urinary urgency
5%
Vaginal hemorrhage
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Alkaline phosphatase increased
3%
Colonic perforation
3%
Dysarthria
3%
Blood bilirubin increased
3%
CPK increased
3%
Creatinine increased
3%
Myositis
3%
Rectal hemorrhage
3%
Hypothyroidism
3%
Left ventricular systolic dysfunction
3%
Lethargy
3%
Muscle weakness left-sided
3%
Myocarditis
3%
Rectal pain
3%
Weight Loss
3%
Fall
3%
Generalized muscle weakness
3%
Hyperglycemia
3%
Hyperkalemia
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Pleural effusion
3%
Skin infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab
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 (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
~3750
Lurbinectedin
FDA approved
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Small Cell Lung Cancer (SCLC) include immunotherapies like Durvalumab and chemotherapeutic agents like Lurbinectedin. Durvalumab is a monoclonal antibody that targets PD-L1, a protein that allows cancer cells to evade the immune system.
By blocking PD-L1, Durvalumab enhances the immune system's ability to attack cancer cells. Lurbinectedin is an alkylating agent that binds to the DNA of cancer cells, causing DNA damage and leading to cell death.
These treatments are significant for SCLC patients as they offer a dual approach: enhancing the immune response while directly damaging cancer cells, potentially improving treatment outcomes.
The Evolving Continuum of Diagnosis in the Modern Age of Non-Small Cell Lung Cancer.Immunotherapy for LELC: Case Report and a Focused Review.Current challenges and opportunities in treating adult patients with Philadelphia-negative acute lymphoblastic leukaemia.
The Evolving Continuum of Diagnosis in the Modern Age of Non-Small Cell Lung Cancer.Immunotherapy for LELC: Case Report and a Focused Review.Current challenges and opportunities in treating adult patients with Philadelphia-negative acute lymphoblastic leukaemia.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,943 Previous Clinical Trials
41,024,595 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,355 Previous Clinical Trials
3,061,607 Total Patients Enrolled
Konstantinos Leventakos, M.D.Principal InvestigatorMayo Clinic in Rochester
2 Previous Clinical Trials
110 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.