Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors

Browse trials for

• Neoplasms 9,371
• Carcinoma, Neuroendocrine 236

Keywords

• Lurbinectedin
• Monotherapy
• Urothelial cancer
• Poorly differentiated neuroendocrine carcinomas
• Homologous recombination deficient-positive malignancies agnostic

Neoplasms

9,371 studies on the registry are indexed under Neoplasms; 2,492 are open to participants now.

This study's enrollment of 47 is close to the median of 50 across 7,258 interventional studies indexed under Neoplasms.

Lead sponsor

Jazz Pharmaceuticals is the lead sponsor of 167 studies on the registry; 20 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.

Study arms

• Experimental
  Urothelial Cancer Cohort

  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.

  Drug: Lurbinectedin

• Experimental
  Poorly Differentiated Neuroendocrine Carcinomas Cohort

  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.

  Drug: Lurbinectedin

• Experimental
  Homologous Recombination Deficient-Positive Malignancies Agnostic Cohort

  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.

  Drug: Lurbinectedin

Interventions

• DrugLurbinectedin

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

Primary outcomes

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.

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

Secondary outcomes

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.

   Time frame: 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.

   Time frame: 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

   Time frame: 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.

   Time frame: 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

   Time frame: Baseline and every 3 months, up to 16 months

Baseline characteristics

Study documents

• Study protocol · Oct 6, 2022
• Statistical analysis plan · Jan 19, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.