A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC

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

The purpose of this study is to evaluate the efficacy and safety of lurbinectedin in combination with durvalumab for the treatment of participants with extensive stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first line (1L) induction therapy.

Study Overview

• Status: Not yet recruiting
• Conditions: Extensive-stage Small-cell Lung Cancer
• Intervention / Treatment: Drug: Lurbinectedin; Drug: Durvalumab

Detailed Description

The study will evaluate the safety and efficacy of lurbinectedin in combination with durvalumab as maintenance therapy in participants with ES-SCLC after first line induction therapy with durvalumab and platinum plus etoposide containing regimen. In order to be considered for eligibility screening for the maintenance phase, participants need to have an ongoing CR, PR, or stable disease (SD) per RECIST v1.1 criteria after completion of 4 cycles of durvalumab and platinum plus etoposide containing regimen induction treatment.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Clinical Trial Disclosure & Transparency; Phone Number: 215-832-3750; Email: ClinicalTrialDisclosure@JazzPharma.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90067
      • Valkyrie Clinical Trials, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participant has histologically or cytologically confirmed ES-SCLC (per Veterans Administration Lung Study Group staging system).
2. Participant has received 4 cycles of definitive platinum-based chemotherapy with durvalumab
3. Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
4. Must have a life expectancy of ≥ 12 weeks as assessed by the treating physician.
5. Adequate hematologic and end-organ function for at least 7 days prior to dosing.
6. Has a body weight > 30 kg.
7. Adequate contraceptive precautions.

Exclusion Criteria:

1. History of leptomeningeal carcinomatosis.
2. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
3. History of another primary malignancy
4. Presence or history of Central Nervous System (CNS) metastases
5. History of allogeneic organ transplantation.
6. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest CT scan.
7. Any concurrent chemotherapy, study intervention, biologic, or hormonal therapy for cancer treatment.
8. Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention.
9. Concurrent enrollment in another clinical study
10. Prior enrollment or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.
11. Pregnant or breastfeeding or intending to become pregnant during the study or within 6 months after the last dose of study intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Durvalumab and lurbinectedin treatment arm; Durvalumab taken in combination with lurbinectedin in participants with ES-SCLC after first line induction therapy with durvalumab and platinum plus etoposide containing regimen.	Drug: Lurbinectedin; Administered by intravenous (IV) infusion; Other Names: Zepzelca; Drug: Durvalumab; Administered by intravenous (IV) infusion; Other Names: Imfinzi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator assessed PFS rate	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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator assessed PFS	PFS is defined as the time from the start of maintenance treatment until the first documentation of disease progression (as determined by the investigator according to RECIST v1.1) or death due to any cause, whichever occurs first.	Up to 2 years
Investigator-assessed confirmed ORR	Confirmed Objective Response Rate (ORR) is the proportion of participants with Complete Response (CR) or Partial Response (PR) on 2 consecutive occasions ≥ 4 weeks apart, after the start of maintenance treatment, as determined by the investigator according to RECIST v1.1.	Up to 2 years
Number of participants requiring dose modification		Up to 2 years
Number of participants requiring discontinuations of any component of the combination therapy		Up to 2 years
Plasma Concentrations of lurbinectedin		Up to 3 months

Collaborators and Investigators

• Sponsor: Jazz Pharmaceuticals
• Collaborators: Jazz Pharmaceuticals Ireland Limited

Study record dates

Study Major Dates

• Study Start (Estimated): June 12, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Lurbinectedin; Durvalumab; Imfinzi; Zepzelca
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Small Cell Lung Carcinoma; PM 01183; durvalumab
• Other Study ID Numbers: JZP712-203; 2025-524566-13-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No