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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and every 3 months, up to 16 months.
Awards & highlights

EMERGE-201 Trial Summary

This trial is testing lurbinectedin, a new cancer drug, on people with advanced solid tumors.

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.Check my eligibility
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.See study design
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.

EMERGE-201 Trial 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.

EMERGE-201 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Investigator-Assessed Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
Secondary outcome measures
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

EMERGE-201 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 2
~90

Find a Location

Who is running the clinical trial?

Jazz PharmaceuticalsLead Sponsor
248 Previous Clinical Trials
34,312 Total Patients Enrolled

Media Library

Lurbinectedin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05126433 — Phase 2
Bladder Cancer Research Study Groups: Urothelial Cancer Cohort, Poorly Differentiated Neuroendocrine Carcinomas Cohort, Homologous Recombination Deficient-Positive Malignancies Agnostic Cohort
Bladder Cancer Clinical Trial 2023: Lurbinectedin Highlights & Side Effects. Trial Name: NCT05126433 — Phase 2
Lurbinectedin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05126433 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many locales are overseeing this experiment?

"Potential participants have the opportunity to join this study at 15 different locations, including Levine Cancer Institute in Charlotte, Moffit Cancer Center in Tampa and Florida Cancer Specialist in Fort Myers."

Answered by AI

Is Lurbinectedin a reliable treatment with minimal risk to patients?

"Due to the lack of clinical data supporting efficacy, our team at Power gave Lurbinectedin a safety rating of 2."

Answered by AI

Has a comparable investigation ever been conducted before?

"PharmaMar's Lurbinectedin has been trialled since 2016, with 16 trials already concluded. Currently there are 9 active studies for this drug in 21 countries and 65 cities around the world. The first trial had 320 participants and helped to secure Phase 1 & 2 approval from the relevant authorities."

Answered by AI

What is the scope of participants in this clinical trial?

"To ensure data validity, this trial necessitates 60 individuals that satisfy the prerequisites. Patients can enroll at Levine Cancer Institute in Charlotte, North carolina and Moffit Cancer Center in Tampa, Florida."

Answered by AI

Is the enrollment period for this clinical experiment still active?

"According to the clinicaltrials.gov data, this medical trial is accepting participants. It was first published on March 3rd 2022 and recently edited on October 27th 2022."

Answered by AI

Are other experiments being conducted with Lurbinectedin?

"Initially studied in 2016 at Massachusetts General Hospital, lurbinectedin has been subject to 16 finished studies. Currently there are 9 ongoing trials with a significant number based out of Charlotte, North carolina."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors (EMERGE-201)
2022. "Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors (EMERGE-201)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05126433.
~15 spots leftby Apr 2025
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