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New treatment option for Extensive-stage Small-cell Lung Cancer
Official title A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
ClinicalTrials.gov ID: NCT07459634
What this study is testing
What is Lurbinectedin?
Lurbinectedin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for extensive-stage small-cell lung cancer.
Also referred to as Zepzelca.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join 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...
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Jacksonville, Florida, United States
- Atlanta, Georgia, United States
- Rock Hill, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Jacksonville, Florida, United States; Atlanta, Georgia, United States; Rock Hill, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.