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Advanced Solid TumorPhase 2JAZZ EMERGE201NCT05126433

Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors

A Phase 2 study testing Lurbinectedin in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by Jazz Pharmaceuticals at 17 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an open-label, multicenter, phase 2 study of lurbinectedin monotherapy in participants with advanced (metastatic and/or unresectable) solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lurbinectedin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
17 sitesUnited States
Study dates
3 Mar 2022to 20 Dec 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • ≥ 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ and bone marrow function
  • Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • Have advanced (metastatic/unresectable) cancers in one of the following:
Show all 10Show fewer
  • Histologically or cytologically confirmed urothelial cancer
  • Histologically or cytologically confirmed poorly differentiated neuroendocrine carcinoma
  • Histologically or cytologically confirmed homologous recombination deficient-positive malignancies agnostic, which may include 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
  • Adequate contraceptive precautions

Who cannot join

  • Known symptomatic central nervous system (CNS) metastasis requiring steroids
  • History of prior malignancy within 2 years of enrollment
  • Clinically significant cardiovascular disease
  • Active infection requiring systemic therapy
  • Significant non-neoplastic liver disease
  • Prior treatment with trabectedin or lurbinectedin
Show all 11Show fewer
  • Treatment with an investigational agent within 4 weeks of enrollment
  • Received live vaccine with 4 weeks of first dose
  • Prior allogeneic bone marrow or solid organ transplant
  • Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening
  • Positive human immunodeficiency virus (HIV) infection at screening

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Dana Farber

    Boston, Massachusetts, 02215

  • Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Sarah Cannon, Zangmeister Cancer Center

    Columbus, Ohio, 43219

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Bon Secours Hematology and Oncology

    Greenville, South Carolina, 29607

  • MD Anderson

    Houston, Texas, 77030

  • Sarah Cannon, Tennesse Oncology

    Nashville, Tennessee, 37203

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Eastern Connecticut Hematology and Oncology

    Norwich, Connecticut, 06360

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68124

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Pikeville Medical Center

    Pikeville, Kentucky, 41501

  • UPMC Hillman Cancer Center Investigational Drug Service

    Pittsburgh, Pennsylvania, 15232

  • Sarah Cannon, Florida Cancer Specialist

    St. Petersburg, Florida, 33705

  • Stanford Cancer Center

    Stanford, California, 94305

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: EMERGE-201: A Phase 2, Multicenter, Open-label Study of Lurbinectedin Efficacy and Safety in Participants With Advanced or Metastatic Solid Tumors

This is an open-label, multicenter, phase 2 study of lurbinectedin monotherapy in participants with advanced (metastatic and/or unresectable) solid tumors.

Read the detailed description

This phase 2, multicenter, open-label study is designed to assess the safety and efficacy of lurbinectedin monotherapy in 3 cohorts of participants with high-unmet medical need: advanced (metastatic and/or unresectable) urothelial cancer (UC), poorly differentiated neuroendocrine carcinomas (PD-NEC), and a homologous recombination deficient-positive malignancies agnostic cohort.

Being tested
Lurbinectedin
Keywords
Lurbinectedin, Monotherapy, Urothelial cancer, Poorly differentiated neuroendocrine carcinomas, Homologous recombination deficient-positive malignancies agnostic
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LurbinectedinDrug

    Lurbinectedin 3.2 mg/m^2 intravenous (IV) every 3 weeks (Q3W)

Study groups in NCT05126433
Study groupRoleWhat they receive
Urothelial Cancer CohortExperimentalParticipants 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.
Receives: Drug: Lurbinectedin
Poorly Differentiated Neuroendocrine Carcinomas CohortExperimentalParticipants 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.
Receives: Drug: Lurbinectedin
Homologous Recombination Deficient-Positive Malignancies Agnostic CohortExperimentalParticipants 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.
Receives: Drug: Lurbinectedin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The ORR is defined as the proportion of participants whose best overall response (BOR) is investigator-assessed confirmed complete response (CR) or partial response (PR) using the RECIST v1.1 criteria. BOR is defined as the best response recorded between the date of first dose and the date of objectively documented progression per RECIST v1.1, or the date of subsequent anticancer therapy, death due to any cause, loss to follow-up, or study discontinuation, whichever occurs first.

    Measured: Baseline to disease progression or death, up to 36 weeks.

Secondary outcomes (5)

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

    PFS is defined as the time from the first dosing date to the date of first documented disease progression or death due to any cause, whichever occurs first.

    Measured: Baseline to disease progression or death, up to 36 weeks

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

    TTR is defined as the time from the first dosing date to the date of the first confirmed response (complete response [CR] or partial response [PR]), as assessed by the investigators.

    Measured: Baseline to disease progression or death, up to 36 weeks

  3. Investigator-Assessed Duration of Response (DOR) as Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1

    DOR is defined as the time from the first confirmed response (complete response [CR] or partial response [PR]) to the date of the first documented tumor progression as determined using RECIST v1.1 criteria or death due to any cause, whichever occurs first

    Measured: Baseline to disease progression or death, up to 36 weeks

  4. Investigator-assessed Disease Control Rate (DCR) as Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1

    DCR is defined as the proportion of participants whose best overall response (BOR) is confirmed complete response (CR), or partial response (PR), or stable disease (SD) using the RECIST v1.1 criteria.

    Measured: Baseline to disease progression or death, up to 36 weeks.

  5. Overall Survival (OS) in Participants Treated With Lurbinectedin

    OS is defined as the time from the first dosing date to the date of death from any cause. A participant who has not died will be censored at the last known alive date

    Measured: Baseline and every 3 months, up to 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2021
  2. Study start3 Mar 2022
  3. Primary completion20 Dec 2023
  4. Study completion20 Dec 2023

Why it stopped: Termination of this study was a business decision made during portfolio review.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05126433
Sponsor's protocol ID
JZP712-201
Acronym
JAZZ EMERGE201
Status last verified
Feb 2025
First submitted
8 Nov 2021
Last updated
28 Feb 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lurbinectedin in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by Jazz Pharmaceuticals at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigator-Assessed Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 (time frame: Baseline to disease progression or death, up to 36 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05126433.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.

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