Lurbinectedin plus durvalumab for extensive-stage small-cell lung cancer after initial treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial evaluates the safety and efficacy of combining lurbinectedin with durvalumab as maintenance therapy in extensive-stage small-cell lung cancer after completion of first-line platinum-based chemotherapy with durvalumab and etoposide. Eligibility requires measurable disease response or stability after 4 cycles of platinum-based therapy with at least 3 cycles of durvalumab during induction. Participants must have good performance status and organ function, and meet age-appropriate contraception and other standard safety criteria.

Why it matters

Who can join: the full rules

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

Where it's running

• Valkyrie Clinical Trials, Inc.
  Los Angeles, California, United States Recruiting
• Cancer Specialists of North Florida
  Jacksonville, Florida, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• Baptist Health
  Lexington, Kentucky, United States Recruiting
• MidAmerica Cancer Centre
  Kansas City, Missouri, United States Recruiting
• Carolina Blood and Cancer Care
  Rock Hill, South Carolina, United States Recruiting

Study contacts

• Study coordinator: Clinical Trial Disclosure & Transparency
• Email: ClinicalTrialDisclosure@JazzPharma.com
• Phone: 215-832-3750

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.