What side effects are associated with this type of intervention?

Common treatments for bladder cancer, such as chemotherapy and radiation therapy, have several known side effects. Chemotherapy regimens, including cisplatin-based combinations, can cause neutropenic sepsis, neuropathy, nausea, vomiting, diarrhea, and alopecia. Radiation therapy, often used in conjunction with chemotherapy, can lead to local and locoregional control issues, and may cause side effects such as cystitis and gastrointestinal discomfort. These treatments aim to induce apoptosis and inhibit tumor growth, similar to the mechanism of Lurbinectedin, which binds to the DNA minor groove, causing DNA damage and cell death.

What prior FDA approvals exist?

Several drugs have been approved by the FDA for the treatment of bladder cancer, particularly for advanced or metastatic cases. Cisplatin-based chemotherapy regimens, such as methotrexate, vinblastine, doxorubicin, and cyclophosphamide, have been standard treatments. More recently, immune checkpoint inhibitors like Atezolizumab and Pembrolizumab, which target PD-1/PD-L1 pathways to enhance the immune response against cancer cells, have been approved. These treatments, while not identical to Lurbinectedin, share the goal of inducing cancer cell death through different mechanisms.

What other types of research exist?

Promising novel alternatives to Lurbinectedin for bladder cancer patients include: 1) Lupulone, which exhibits anticancer activity by inducing apoptosis and regulating proteins associated with cell death. 2) Luteolin, which has anti-inflammatory, antioxidant, and antiapoptotic properties, and has shown effectiveness in reducing bladder damage and apoptosis in cyclophosphamide-induced cystitis models. Both agents have demonstrated potential in preclinical studies and could be considered for further investigation in bladder cancer treatment.

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Alkylating agents

Lurbinectedin for Solid Tumors (EMERGE-201 Trial)

Phase 2

Waitlist Available

Research Sponsored by Jazz Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 18 years of age

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Must not have

Known symptomatic central nervous system (CNS) metastasis requiring steroids

History of prior malignancy within 2 years of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and every 3 months, up to 16 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a medication called lurbinectedin, which is given alone. It is aimed at patients with advanced cancers that are hard to treat and have few options. The medication works by targeting the DNA in cancer cells, making it difficult for them to grow and spread. Lurbinectedin received FDA accelerated approval for treating metastatic small cell lung cancer after progression on platinum-based chemotherapy.

Who is the study for?

This trial is for adults over 18 with advanced solid tumors, including specific cancers like urothelial and neuroendocrine carcinoma. Participants must have measurable disease, be in good physical condition (ECOG 0 or 1), and have proper organ function. They can't join if they've had cancer within the last two years, significant heart issues, recent investigational drugs or live vaccines, transplants, active hepatitis B/C or HIV infections, symptomatic brain metastasis requiring steroids, ongoing infection treatments or liver disease.

What is being tested?

The study tests Lurbinectedin as a single therapy for various advanced solid tumors to see how effective it is on its own. It's an open-label phase 2 trial where all participants receive lurbinectedin and are monitored for their response according to standard criteria.

What are the potential side effects?

Lurbinectedin may cause side effects such as fatigue; nausea; hair loss; decreased blood cells leading to higher infection risk, bruising or bleeding; liver problems; lung issues causing breathing difficulties; allergic reactions during infusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My cancer is advanced and cannot be removed by surgery, and it's one of the specified types with a certain genetic mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need steroids for my brain metastasis symptoms.

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I have had cancer other than my current one in the last 2 years.

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I have a serious heart condition.

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I am currently on medication for an infection.

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I have a serious liver condition not caused by cancer.

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I have previously been treated with trabectedin or lurbinectedin.

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I have had a bone marrow or organ transplant from another person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and every 3 months, up to 16 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and every 3 months, up to 16 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and every 3 months, up to 16 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Investigator-Assessed Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1

Secondary study objectives

Investigator-Assessed Duration of response (DOR) as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1

Investigator-Assessed Progression Free Survival (PFS) as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1

Investigator-Assessed Time-To-Response (TTR) as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Urothelial Cancer CohortExperimental Treatment1 Intervention

Participants with advanced (metastatic and/or unresectable) urothelial carcinoma who have progressed on platinum-containing regimen (prior therapies may include but are not limited to immune checkpoint inhibitor, enformumab vendotin, or sacituzumab govitecan) will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.

Group II: Poorly Differentiated Neuroendocrine Carcinomas CohortExperimental Treatment1 Intervention

Participants with advanced (metastatic and/or unresectable) poorly differentiated neuroendocrine carcinomas who received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.

Group III: Homologous Recombination Deficient-Positive Malignancies Agnostic CohortExperimental Treatment1 Intervention

Participants with advanced (metastatic and/or unresectable) endometrial, biliary tract, urothelial, breast (TNBC or HR+HER2- breast cancer), pancreas, gastric, or esophageal solid tumors with preidentified germline and/or somatic pathogenic mutation and received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lurbinectedin

2022

Completed Phase 3

~780

0 / 10Eligibility 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

Common treatments for bladder cancer include chemotherapy, radiation, and targeted therapies. Chemotherapy drugs, such as cisplatin and methotrexate, work by damaging the DNA of cancer cells, leading to cell death. Radiation therapy uses high-energy rays to kill cancer cells by causing DNA damage. Targeted therapies, like those being studied with Lurbinectedin, inhibit specific molecules involved in cancer cell growth and survival. Lurbinectedin binds to the DNA minor groove, causing DNA damage and inducing apoptosis. These mechanisms are crucial for bladder cancer patients as they directly target the cancer cells' ability to proliferate and survive, potentially leading to better treatment outcomes.

Altered RECQL5 expression in urothelial bladder carcinoma increases cellular proliferation and makes RECQL5 helicase activity a novel target for chemotherapy.Role of XIAP in the malignant phenotype of transitional cell cancer (TCC) and therapeutic activity of XIAP antisense oligonucleotides against multidrug-resistant TCC in vitro.