lurbinectedin
lurbinectedin: sourced relationships with 1 company · 17 clinical trials tracked · 1 FDA decision.
lurbinectedin evidence translation
What we can confirm
1 FDA record · 17 tracked trials
What it means
What to watch
Prepared research question
How could lurbinectedin → JAZZ affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 2 study sponsors
Related indications
Dated Pipeline Records (2)
| Company | Dated record stage |
|---|---|
| Jazz Pharmaceuticals plc (JAZZ) | Approved |
| Jazz Pharmaceuticals plc (JAZZ) Reported 2020-06-15 · Current development: unknownSource Refractory Ewing Sarcoma; Advanced Solid Tumor; Extensive St… | Phase 2 |
Clinical Trial Registry Records (17)showing 10 most recent
A Phase 2, Multicenter, Open-Label, Single-Arm Study of Lurbinectedin in Combination With Durvalumab as First-line Maintenance Therapy in Participants With Extensive-Stage Small-Cell Lung Cancer Following Induction Treatment With Platinum Based Chemotherapy and Durvalumab
Primary endpoint: Investigator assessed PFS rate
Phase I/II Trial of Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer
Primary endpoint: Grade 3 or dose-limiting toxicities
A Phase 3 Randomized, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of ABBV-706 Versus Standard of Care in Subjects With Relapsed/Refractory Small Cell Lung Cancer (SCLC)
Primary endpoint: Objective Response (OR) as Measured by Overall Response Rate (ORR) Based on Blinded Independent Central Review (BICR)
A Phase 2 Randomized, Open Label, Multicenter Study to Evaluate the Optimal Dose, Safety, and Efficacy of ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Subjects With Previously Untreated Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Primary endpoint: Number of Participants with Adverse Events (AE)s
A Global, Multicenter, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care (SOC) in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Primary endpoint: Overall Survival (OS)
A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice (TPC) in Subjects With Relapsed Small Cell Lung Cancer (SCLC) (IDeate-Lung02)
Primary endpoint: Overall Survival (OS)
Randomized, Controlled, Open-label, Phase III Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Patients With Metastatic Leiomyosarcoma
Primary endpoint: PFS by IRC
Lurbinectedin in FET-Fusion Tumors (LIFFT)
Primary endpoint: Phase 1: Dose Limiting Toxicities (DLTs)
Phase 1b of Lurbinectedin in Combination With Weekly Paclitaxel and Bevacizumab in Platinum-resistant Ovarian Cancer
Primary endpoint: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
A Phase 1/2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Recommended Phase 2 Dose (RP2D), and Efficacy of Lurbinectedin Monotherapy in Pediatric Participants With Previously Treated Solid Tumors Followed by Expansion to Assess Efficacy and Safety in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma.
Primary endpoint: Phase 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with lurbinectedin?
lurbinectedin has dated SEC/FDA relationship records for Jazz Pharmaceuticals plc.
How many clinical trials involve lurbinectedin?
BioSniper tracks 17 clinical trials involving lurbinectedin.
What is lurbinectedin's latest FDA decision?
The most recent tracked FDA decision for lurbinectedin is Approval for 1 INDICATIONS AND USAGE ZEPZELCA is an alkylating drug indicated: • in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, for the maintenance treatment of adult patients with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide. ( 1.1 ) • For the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. ( 1.2 ) This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.2 ) 1.1 Extensive-Stage Small Cell Lung Cancer ZEPZELCA, in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, is indicated for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide. 1.2 Metastatic Small Cell Lung Cancer ZEPZELCA is indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s)., dated June 15, 2020.