Recruiting
Phase 2

Lurbinectedin & Durvalumab

Sponsor:

Jazz Pharmaceuticals

Code:

NCT07459634

Conditions

Extensive-stage Small-cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lurbinectedin

Durvalumab

Study Details

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

Study ID

NCT07459634

Start date

Aug 30, 2026

Status verified date

Jul, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Lurbinectedin

Administered by intravenous (IV) infusion

Durvalumab

Administered by intravenous (IV) infusion

Primary outcome measure

  • Investigator assessed PFS rate [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Clinical Trial Disclosure & Transparency

215-832-3750ClinicalTrialDisclosure@JazzPharma.com

Locations

Valkyrie Clinical Trials, Inc.

Recruiting

Los Angeles, California, United States, 90067

Cancer Specialists of North Florida

Recruiting

Jacksonville, Florida, United States, 32256

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Carolina Blood and Cancer Care

Recruiting

Rock Hill, South Carolina, United States, 29732

More Information

Sponsor

Jazz Pharmaceuticals

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

  • Zepzelca
  • Lurbinectedin
  • Durvalumab
  • Imfinzi

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jazz Pharmaceuticals on 2026-07-20.