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RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well lurbinectedin with durvalumab works and how safe it is. It is for people with small cell lung cancer that has spread widely and has not gotten worse after their first treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Tests of tissue or cells confirm small cell lung cancer that has spread widely.
  • Have had 4 rounds of platinum-based chemotherapy, including at least 3 rounds of durvalumab.
  • Are fully active or can do light work but not hard physical activity.
  • Your doctor expects you to live at least 12 weeks.
  • Have good enough blood counts and organ function for at least 7 days before treatment.
  • Weigh more than 30 kg (about 66 pounds).
  • Use suitable birth control.

Who can't join

  • Have cancer in the lining around the brain or spinal cord, or have ever had cancer spread to the brain or spinal cord.
  • Have fluid around the lungs or heart, or in the belly, that is not controlled and needs repeated draining.
  • Had serious heart or blood vessel disease within 3 months before joining.
  • Have a history of another separate cancer or have received an organ transplant from another person.
  • Have a history of certain lung scarring or inflammation, including inflammation caused by medicine or with no known cause, or have active lung inflammation on the screening CT scan.
  • Are getting other chemotherapy, study treatment, biologic therapy, or hormone therapy for cancer.
  • Received a vaccine containing a weakened live germ within 30 days before the first study dose.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study or within 6 months after the last study dose.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (5)

CA

FL

GA

KY

SC