Clinical Trials in Italy / NCT07218146
Recruiting
Phase 3
A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE)
NCT07218146 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Small-cell Lung Cancer
Investigational drug(s) / intervention(s)
ZL-1310 →Investigator's Choice of Therapy
ZL-1310: ZL-1310 as a single-agent
Investigator's Choice of Therapy: Topotecan or Amrubicin
Study summary
The purpose of this study is to evaluate the efficacy and safety of ZL-1310 compared to Investigator's Choice Therapy in participants with relapsed Small Cell Lung Cancer.
Eligibility
Inclusion Criteria:
* Age \>/= 18 years, or considered an adult by local regulations, at the time of consent
* Signed informed consent
* Histologically or cytologically confirmed SCLC. Received 1L platinum-based systemic therapy and had documented disease progression during or after the most recent systemic therapy. Or received 2L tarlatamab is allowed.
* Measurable disease according to RECIST v1.1 as assessed by the investigator.
* Participants with a history of treated and stable or untreated and asymptomatic CNS metastases based on criteria per protocol.
* Adequate organ and marrow function
* Eastern Cooperative Group (ECOG) performance status of 0 or 1
* Life expectancy of at least 3 months
* Participants must be willing to undergo a tumor biopsy or provide archived tumor tissue sample at Screening
* Participants must be willing and able to comply with protocol for the duration of the study
Exclusion Criteria:
* Received more than one line of systemic therapy for Extensive-Stage SCLC.
* Received any prior ADC with topoisomerase 1 inhibitor payload
* Participants with another known malignancy with exceptions defined in the protocol.
* History or suspected ILD/pneumonitis based on criteria per protocol
* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
* Receipt of anti-cancer treatment known to treat cancers within 3 weeks before the first dose of study treatment.
* Prior radiotherapy before study treatment based on criteria per protocol
* Unresolved toxicity of Grade \>/= 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation.
* Known infection or active infection defined in the protocol.
* Clinically significant active cardiovascular disease or history of arterial thromboembolic event within 6 months prior to the first dose of study treatment based on criteria per protocol.
Primary outcome measure(s)
- Confirmed objective response rate (ORR) assessed by Blinded Independent Central Review of ZL-1310 compared to Investigator's Choice Therapy (ICT) — up to 30 months
- Overall survival of ZL-1310 compared to Investigator's Choice Therapy (ICT) — up to 30 months
Trial sites (155)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California San Diego | La Jolla | California | Recruiting |
| UC Davis Comprehensive Cancer Center | Sacramento | California | Recruiting |
| University of Colorado | Aurora | Colorado | Recruiting |
| Yale Cancer Center/Clinical Trials Office | New Haven | Connecticut | Recruiting |
| Clermont Oncology Center | Clermont | Florida | Recruiting |
| Mid Florida Hematology and Oncology Center | Orange City | Florida | Recruiting |
| Cancer Centers of Bevard | Rockledge | Florida | Recruiting |
| Sarah Cannon Research Institute | Sarasota | Florida | Recruiting |
| Florida Cancer Specialists - North | St. Petersburg | Florida | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | Recruiting |
| Florida Cancer Specialists - East | West Palm Beach | Florida | Recruiting |
| Illinois Cancer Care | Peoria | Illinois | Recruiting |
| OSF St. Francis Medical Center | Peoria | Illinois | Recruiting |
| University of Iowa | Iowa City | Iowa | Recruiting |
| University of Iowa Mission Health Cancer + Blood | Waukee | Iowa | Recruiting |
| Norton Cancer Institute | Louisville | Kentucky | Recruiting |
| American Oncology Partners, PA - The Center for Cancer and Blood Disorders | Bethesda | Maryland | Recruiting |
| Maryland Oncology Hematology | Silver Spring | Maryland | Recruiting |
| Henry Ford Health Cancer | Detroit | Michigan | Recruiting |
| Missouri Cancer Associates | Columbia | Missouri | Recruiting |
| Mercy South | St Louis | Missouri | Recruiting |
| Stony Brook Cancer Center | Stony Brook | New York | Recruiting |
| Montefiore Medical Center | The Bronx | New York | Recruiting |
| Cleveland Clinic - Akron General Medical Center | Akron | Ohio | Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | Recruiting |
| Cleveland Clinic - Fairview Hospital Molly Pavilion | Cleveland | Ohio | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| Cleveland Clinic - Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio | Recruiting |
| Consultants in Medical Oncology and Hematology | Broomall | Pennsylvania | Recruiting |
| Alliance Cancer Specialists | Media | Pennsylvania | Recruiting |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | Recruiting |
| University of Pittsburgh (UPMC) Hillman Cancer Center | Pittsburgh | Pennsylvania | Recruiting |
| SCRI OP (Oncology Partners) | Nashville | Tennessee | Recruiting |
| Texas Oncology - Central South | Austin | Texas | Recruiting |
| University of Texas Southwestern Medical Center/Clinical Research Department | Dallas | Texas | Recruiting |
| Texas Oncology - West Texas | Odessa | Texas | Recruiting |
| Virginia Cancer Specialists | Fairfax | Virginia | Recruiting |
| Uniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU Department of Internal Medicine III | Salzburg | Austria | Recruiting |
| Universitair Ziekenhuis Antwerpen | Edegem | Belgium | Recruiting |
| Algemeen Ziekenhuis Sint-Lucas | Ghent | Belgium | Recruiting |
+ 115 more sites — see the full list on the official registry below.
Other trials for the same condition
Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07218146 on ClinicalTrials.gov ↗ ← All trials in Italy