Clinical Trials Logo
  1. Home
  2. Small Cell Lung Cancer
  3. NCT04291937
  4. Details
NCT04291937 Clinical Trial

A Multicenter Expanded Access Treatment Protocol of Lurbinectedin in Previously Treated SCLC in the USA

Small Cell Lung Cancer Clinical Trial

Official title:
A Multicenter Expanded Access Treatment Protocol of Lurbinectedin (PM01183) in Previously Treated Small Cell Lung Cancer in the USA

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT04291937
Other study ID # LUR_EAP-001-2019
Secondary ID
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date June 2020
Source Jazz Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

This is an expanded access program in the USA to enable eligible patients with previously treated small cell lung cancer to access lurbinectedin treatment prior to FDA approval. Sites must apply to participate in the program. A medical doctor must assess whether the potential benefit outweighs the risk of the investigational therapy considering the program eligibility criteria and the individual patient's medical history.

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Legally competent adult

- Confirmed and unresectable Small Cell Lung Cancer (SCLC)

- Patients must have received one prior chemotherapy containing line

- Adequate organ, hematological, kidney, metabolic and liver function

- Recovery from toxicities related to previous treatment(s)

- Pregnancy must be excluded, medically acceptable contraception method

Exclusion Criteria:

- Prior treatment with lurbinectedin

- Certain concomitant diseases/conditions

- Symptomatic, steroid-requiring or progressive CNS involvement.

- Pregnant or breast-feeding women.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lurbinectedin
Powder for concentrate for solution for infusion in 4 mg vials

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Jazz Pharmaceuticals
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03651219 - Mesylate Apatinib Combined With Irinotecan in Treatment of Recurrent Small Cell Lung Cancer Phase 3
Active, not recruiting NCT03958045 - Combination Rucaparib With Nivolumab in Small Cell Lung Carcinoma Phase 2
Completed NCT04381910 - Irinotecan Hydrochloride Liposome Injection (LY01610) For Small Cell Lung Cancer Phase 2
Active, not recruiting NCT04885998 - AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC) Phase 1
Active, not recruiting NCT03703297 - Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy Phase 3
Recruiting NCT05903092 - MOnaliZumab in Combination With durvAlumab (MEDI4736) Plus Platinum-based chemotheRapy for First-line Treatment of Extensive Stage Small Cell Lung Cancer Phase 2
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Terminated NCT04422210 - A Study Evaluating The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Venetoclax In Combination With Atezolizumab, Carboplatin, And Etoposide In Participants With Untreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC). Phase 1
Not yet recruiting NCT02875457 - Apatinib as the Maintenance Therapy for Extensive Stage Small Cell Lung Cancer After Combined With Etoposide/Cisplatin Phase 3
Recruiting NCT02605811 - Temozolomide in Preventing Brain Metastases in Small Cell Lung Cancer Phase 2
Recruiting NCT02577627 - Multi-Indication, Retrospective Oncological Study to Validate the Accuracy in Predicting TTP by PrediCare in Patients Under SOC N/A
Completed NCT02551432 - Pembrolizumab and Paclitaxel in Refractory Small Cell Lung Cancer Phase 2
Withdrawn NCT02542137 - Abscopal Effect for Metastatic Small Cell Lung Cancer Phase 2
Recruiting NCT02262897 - The Efficacy and Safety of Nab-paclitaxel in Pretreated Patients With Extensive Disease of Small Cell Lung Cancer Phase 2
Completed NCT01943578 - Value of Physical Capacity Tests in Lung Cancer N/A
Completed NCT01831089 - Phase I Study of Lurbinectedin (PM01183) in Combination With Paclitaxel, With or Without Bevacizumab, in Selected Advanced Solid Tumors Phase 1
Terminated NCT00969306 - Chloroquine as an Anti-Autophagy Drug in Stage IV Small Cell Lung Cancer (SCLC) Patients Phase 1
Completed NCT01497873 - A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer Phase 2
Terminated NCT00958022 - Carboplatin and Etoposide Plus LBH589 for Small Cell Lung Cancer Phase 1
Completed NCT00930891 - Bevacizumab in Extensive Small Cell Lung Cancer Phase 2/Phase 3