Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors (EMERGE-201)

Advanced Solid Tumor Clinical Trial

— EMERGE-201  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05126433
• Other study ID #: JZP712-201
• Status: Completed
• Phase: Phase 2
• Start date: March 3, 2022
• Est. completion date: December 20, 2023

Study information

• Verified date: February 2024
• Source: Jazz Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Signed informed consent

2. = 18 years of age

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

4. Adequate organ and bone marrow function

5. Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

6. Have advanced (metastatic/unresectable) cancers in one of the following:

1. Histologically or cytologically confirmed urothelial cancer

2. Histologically or cytologically confirmed poorly differentiated neuroendocrine carcinoma

3. 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

7. Adequate contraceptive precautions

Exclusion Criteria:

1. Known symptomatic central nervous system (CNS) metastasis requiring steroids

2. History of prior malignancy within 2 years of enrollment

3. Clinically significant cardiovascular disease

4. Active infection requiring systemic therapy

5. Significant non-neoplastic liver disease

6. Prior treatment with trabectedin or lurbinectedin

7. Treatment with an investigational agent within 4 weeks of enrollment

8. Received live vaccine with 4 weeks of first dose

9. Prior allogeneic bone marrow or solid organ transplant

10. Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening

11. Positive human immunodeficiency virus (HIV) infection at screening

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Carcinoma, Neuroendocrine
• Metastatic Solid Tumor
• Neoplasms
• Urothelial Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Dana Farber	Boston	Massachusetts
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Sarah Cannon, Zangmeister Cancer Center	Columbus	Ohio
United States	Inova Schar Cancer Institute	Fairfax	Virginia
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Bon Secours Hematology and Oncology	Greenville	South Carolina
United States	MD Anderson	Houston	Texas
United States	Sarah Cannon, Tennesse Oncology	Nashville	Tennessee
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Eastern Connecticut Hematology and Oncology	Norwich	Connecticut
United States	Oncology Hematology West, PC dba Nebraska Cancer Specialists	Omaha	Nebraska
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Pikeville Medical Center	Pikeville	Kentucky
United States	UPMC Hillman Cancer Center Investigational Drug Service	Pittsburgh	Pennsylvania
United States	Sarah Cannon, Florida Cancer Specialist	Saint Petersburg	Florida
United States	Stanford Cancer Center	Stanford	California
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Jazz Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to disease progression or death, up to 36 weeks.
Secondary	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.	Baseline to disease progression or death, up to 36 weeks.
Secondary	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.	Baseline to disease progression or death, up to 36 weeks.
Secondary	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.	Baseline to disease progression or death, up to 36 weeks.
Secondary	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.	Baseline to disease progression or death, up to 36 weeks.
Secondary	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.	Baseline and every 3 months, up to 16 months.