What side effects are associated with this type of intervention?

Common treatments for Small Cell Lung Cancer (SCLC) include monoclonal antibodies like Durvalumab and alkylating agents like Lurbinectedin. Durvalumab, a PD-L1 inhibitor, can cause side effects such as fatigue, cough, shortness of breath, and immune-related adverse events like pneumonitis, hepatitis, and colitis. Lurbinectedin, an alkylating agent, may lead to side effects including nausea, vomiting, fatigue, neutropenia, and anemia. Chemotherapy, often used in combination with these agents, can cause additional side effects such as hair loss, increased risk of infection, and gastrointestinal issues.

What prior FDA approvals exist?

The FDA has approved several treatments for Small Cell Lung Cancer (SCLC) that are similar to Durvalumab and Lurbinectedin. Atezolizumab, another PD-L1 inhibitor, was approved in combination with carboplatin and etoposide for the first-line treatment of extensive-stage SCLC. This combination showed improved overall survival and progression-free survival compared to chemotherapy alone. Additionally, the alkylating agent Lurbinectedin has been granted accelerated approval for adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy. These approvals highlight the ongoing efforts to enhance SCLC treatment through immunotherapy and alkylating agents.

What other types of research exist?

Promising novel alternatives for Small Cell Lung Cancer (SCLC) patients include: 1) Nivolumab (a PD-1 inhibitor) which has shown efficacy in patients with advanced SCLC, particularly in combination with Ipilimumab (a CTLA-4 inhibitor). 2) Atezolizumab (a PD-L1 inhibitor) in combination with chemotherapy, which has been approved for extensive-stage SCLC based on improved overall survival. 3) Lurbinectedin as a monotherapy, which has shown promising results in patients with relapsed SCLC. These alternatives offer different mechanisms of action and have demonstrated potential in clinical trials.

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Monoclonal Antibodies

Durvalumab + Lurbinectedin for Small Cell Lung Cancer

Q: What is the mechanism of action of this treatment?

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.

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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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 more

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129

65%

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

Colitis

Dry mouth

Dry skin

Fever

Anal pain

Edema limbs

Flatulence

Headache

Hot flashes

Myalgia

Small intestinal obstruction

Thromboembolic event

Urinary frequency

Urinary tract pain

Confusion

Renal and urinary disorders - Other, specify

Adrenal insufficiency

Anemia

Ascites

Gastroesophageal reflux disease

Hypomagnesemia

Lymphedema

Memory impairment

Mucositis oral

Pneumonitis

Rash acneiform

Sinus bradycardia

Upper respiratory infection

Urinary urgency

Vaginal hemorrhage

Alanine aminotransferase increased

Aspartate aminotransferase increased

Alkaline phosphatase increased

Colonic perforation

Dysarthria

Blood bilirubin increased

CPK increased

Creatinine increased

Myositis

Rectal hemorrhage

Hypothyroidism

Left ventricular systolic dysfunction

Lethargy

Muscle weakness left-sided

Myocarditis

Rectal pain

Weight Loss

Fall

Generalized muscle weakness

Hyperglycemia

Hyperkalemia

Pain in extremity

Peripheral sensory neuropathy

Pleural effusion

Skin infection

100%

80%

60%

40%

20%

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

0 / 19Eligibility criteria met

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.