Study Comparing ZL-1310 to Other Treatments for Relapsed Small Cell Lung Cancer
Sponsor: Zai Lab (Shanghai) Co., Ltd.
ClinicalTrials ID:NCT07218146
This clinical trial is testing a new drug, ZL-1310, to see if it is safe and effective compared to other treatments chosen by doctors for patients with small cell lung cancer that has returned after initial treatment.
Patient Parameters
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Program Overview
The aim of this study is to find out if the new drug ZL-1310 works better and is safer than other treatments chosen by doctors for patients whose small cell lung cancer has come back after previous treatment. Participants will receive either ZL-1310 or a treatment selected by their doctor, and researchers will monitor their health and the cancer's response to the treatment.
Eligibility Criteria
Inclusion Criteria
- Be 18 years or older, or considered an adult by local standards.
- Have signed a consent form agreeing to participate.
- Have a confirmed diagnosis of small cell lung cancer (SCLC).
- Have received initial treatment with platinum-based chemotherapy and experienced cancer progression during or after this treatment, or have received a second-line treatment called tarlatamab.
- Have measurable cancer according to specific medical criteria.
- Have a history of treated and stable, or untreated and symptom-free, cancer spread to the brain or spinal cord.
- Have good organ and bone marrow function.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have a life expectancy of at least 3 months.
- Be willing to undergo a tumor biopsy or provide a previous tumor sample.
- Be willing and able to follow the study procedures for its duration.
Exclusion Criteria
- Have received more than one line of treatment for extensive-stage small cell lung cancer.
- Have previously received a specific type of drug called ADC with topoisomerase 1 inhibitor.
- Have another type of cancer, with some exceptions.
- Have a history or suspicion of lung diseases like interstitial lung disease or pneumonitis.
- Have severe lung problems due to other lung illnesses.
- Have received any cancer treatment within 3 weeks before starting the study treatment.
- Have had prior radiation therapy before starting the study treatment, based on specific criteria.
- Have unresolved side effects from previous cancer treatments, except for hair loss and skin color changes.
- Have a known or active infection.
- Have significant heart disease or a history of blood clots in the arteries within 6 months before starting the study treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Zai Lab Site 02045 | 34711 | Clermont | Florida |
| Zai Lab Site 02031 | 32763 | Orange City | Florida |
| Zai Lab Site 02026 | 34232 | Sarasota | Florida |
| Zai Lab Site 02019 | 61615 | Peoria | Illinois |
| Zai Lab Site 02049 | 61637 | Peoria | Illinois |
| Zai Lab Site 02041 | 40202 | Louisville | Kentucky |
| Zai Lab Site 02003 | 20817 | Bethesda | Maryland |
| Zai Lab Site 02023 | 65201 | Columbia | Missouri |
| Zai Lab Site 02019 | 19063 | Media | Pennsylvania |
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