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

NCT07459634 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: JZP712-2032025-524566-13-00
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Extensive-stage Small-cell Lung Cancer

Keywords

Zepzelca; Lurbinectedin; Durvalumab; Imfinzi

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Investigator assessed PFS

  Up to 2 years

• Investigator-assessed confirmed ORR

  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

Study Arms (1)

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.

Drug: Lurbinectedin; Drug: Durvalumab

Interventions

Lurbinectedin DRUG

Administered by intravenous (IV) infusion

Also known as: Zepzelca

Durvalumab and lurbinectedin treatment arm

Durvalumab DRUG

Administered by intravenous (IV) infusion

Also known as: Imfinzi

Durvalumab and lurbinectedin treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead
• Jazz Pharmaceuticals Ireland Limited: collaborator

Study Sites (1)

Valkyrie Clinical Trials, Inc.

Los Angeles, California, 90067, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

PM 01183; durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Clinical Trial Disclosure & Transparency

CONTACT

215-832-3750; ClinicalTrialDisclosure@JazzPharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 10, 2026
• Study Start: June 12, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)