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Label indication 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. FDA label
Also known as PM01183, Zepzelca, JZP712
Lurbinectedin · 6 trials · 10 indications
PFS was defined as the time from randomization to the date of first documented PD as determined by the IRF according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or death, whichever occurs first. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimetres (mm).
OS was defined as the time from randomization to the date of death from any cause.
To evaluate the antitumor activity of Lurbinectedin in terms of overall response rate (ORR), according to RECIST v.1.1, in patients with advanced pancreatic cancer with DNA repair mutations.
Progression Free Survival (PFS) rate is the proportion of participants who have not experienced disease progression (as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) or death from any cause
Will be defined as having one or none of the following: * Grade 4 or 5 serious adverse events possibly, probably, or definitely related to protocol treatment from 30 days from the start of RT. * Any adverse events possibly, probably, or definitely related to protocol treatment that leads to prolonged dose delays (defined as with-holding of two consecutive doses of lurbinectedin). * Any adverse event possibly, probably, or definitely related to treatment resulting in the permanent discontinuation of lurbinectedin. Will be analyzed separately for safety cohorts 1 and 2 and will be summarized descriptively using frequencies and percentages. These will be compared to rates reported by Trigo et al. from lurbinectedin monotherapy.
The number of incidences of grade 3 or dose-limiting toxicities of the combination of lurbinectedin with osimertinib assessed using NCI CTCAE v5.0 criteria.
| Arm | Type | Description |
|---|---|---|
| Arm A: Atezolizumab+Lurbinectedin | EXPERIMENTAL | Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle in combination with lurbinectedin on Day 1 of each 21-day cycle. |
| Arm B: Atezolizumab | ACTIVE_COMPARATOR | Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle. |
| Lurbinectedin | EXPERIMENTAL | Lurbinectedin will be administered intravenously (IV) as a 1-hour (±10 min) infusion on Day 1 of each cycle (one cycle = 3 weeks ± 48 hours). |
| Durvalumab and lurbinectedin treatment arm | EXPERIMENTAL | Durvalumab taken in combination with lurbinectedin in participants with ES-SCLC after first line induction therapy with durvalumab and platinum plus etoposide containing regimen. |
| Treatment (lurbinectedin and palliative radiation therapy) | EXPERIMENTAL | Patients undergo palliative RT over 5 or 10 treatment fractions at the discretion of the treating physician daily for 21 days. Patients also receive lurbinectedin IV over 1 hour on day 1 of each cycle. Cycles of lurbinectedin repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
| Phase I Does De-Escalation | EXPERIMENTAL | 3.2 mg/m2 or 2.6 mg/m2 dose of lurbinectedin with 80 mg or 40 mg daily dose of osimertinib. This will occur day 1 of each 21 day cycle. |
| Phase II Dose Expansion | EXPERIMENTAL | 3.2 mg/m2 or 2.6 mg/m2 dose of lurbinectedin with 80 mg or 40 mg daily dose of osimertinib. This will occur day 1 of each 21 day cycle. |
| Phase 1 Part 1: Dose Selection | EXPERIMENTAL | Pediatric participants ≥ 2 to \< 18 years of age with previously treated solid tumors of any histology at 5 dose levels to determine the RP2D, followed by a safety expansion cohort. Participants aged ≥ 6 to \< 18 years will be enrolled at the starting dose of 3.2 mg/m\^2 lurbinectedin. If, after review, the starting dose of 3.2 mg/m\^2 lurbinectedin Q3W is deemed safe in participants aged ≥ 6 to \< 18 years, participants aged ≥ 2 to \< 6 years may enroll and start at the dose as determined by the DMC. After this, the study opens to all participants (aged ≥ 2 to \< 18 years) for all dose levels. Upon completion of the cohort at all dose levels, participants may be eligible to enroll in a safety expansion cohort. |
| Phase 1 Part 2: RP2D | EXPERIMENTAL | Participants aged ≥ 2 to ≤ 30 years with recurrent/refractory Ewing sarcoma at the RP2D to assess safety and efficacy signals. |
| Phase 2 | EXPERIMENTAL | If a signal of efficacy is observed in Phase 1 Part 2, additional participants aged ≥ 2 to ≤ 30 years with recurrent/refractory Ewing sarcoma will be enrolled. Phase 2 will further assess the safety and efficacy of lurbinectedin monotherapy. |
| Name | Type | Description |
|---|---|---|
| Atezolizumab | DRUG | Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle for 4 cycles in the induction phase. Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle in the maintenance phase. |
| Lurbinectedin | DRUG | Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 of each 21-day cycle in the maintenance phase. |
| Carboplatin | DRUG | Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase. |
| Etoposide | DRUG | Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase. |
| Lurbinectedin 4 MG Injection [Zepzelca] | DRUG | Lurbinectedin will be administered with a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride). Lurbinectedin will be administered intravenously through peripheral or central lines at a dose of 3.2 mg/m2 at a fixed infusion rate. |
| Durvalumab | DRUG | Administered by intravenous (IV) infusion |
| Palliative Radiation Therapy | RADIATION | Undergo RT |
| Osimertinib | DRUG | Two osimertinib does of 80 mg or 40 mg orally once daily, as assigned by the dose de-escalation cohort for each 21 day cycle. |
Inclusion Criteria for the Induction Phase: * ECOG PS of 0 or 1 * No prior systemic therapy for ES-SCLC * Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC * Histologically or cytologic...
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Lurbinectedin is a small molecule oncology drug developed by Jazz Pharmaceuticals plc (ticker JAZZ). It is being studied in extensive-stage small-cell lung cancer, gastrointestinal malignancies, and refractory Ewing sarcoma. It is also known by the name Lurbinectedin 4 MG Injection [Zepzelca]. It is investigational and remains in clinical development.
Lurbinectedin is being studied for extensive-stage small-cell lung cancer, including transformed small-cell lung cancer, as well as gastrointestinal malignancies and relapsed or refractory Ewing sarcoma. Research includes use as monotherapy and in combinations with agents such as durvalumab, osimertinib, and palliative radiotherapy. It is investigational and not established as an approved treatment.
Lurbinectedin is developed by Jazz Pharmaceuticals plc, which trades under the ticker JAZZ. The company is the sponsor behind the clinical trial program evaluating the drug across small-cell lung cancer and Ewing sarcoma studies in the United States and Canada.
Lurbinectedin is in clinical development, with trials spanning Phase 1 and Phase 2. It is investigational and has not been established as approved. The program includes Phase 1 studies in Ewing sarcoma and transformed small-cell lung cancer, and a Phase 2 study combining lurbinectedin with durvalumab in extensive-stage small-cell lung cancer.
Active lurbinectedin trials include NCT07459634, a Phase 2 study with durvalumab in extensive-stage small-cell lung cancer; NCT07153055, a Phase 1 study with osimertinib in transformed small-cell lung cancer; NCT05734066, a Phase 1 monotherapy study in relapsed or refractory Ewing sarcoma; and NCT05244239, a Phase 1 study with palliative radiotherapy in extensive-stage small-cell lung cancer.
Lurbinectedin is also known as Lurbinectedin 4 MG Injection [Zepzelca]. Searches for Zepzelca refer to the same small molecule oncology drug developed by Jazz Pharmaceuticals plc (ticker JAZZ) and studied across small-cell lung cancer, gastrointestinal malignancies, and Ewing sarcoma.