A Study of ZL-1310 in Subjects With Small Cell Lung Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
ZL-1310: Drug: ZL-1310
Atezolizumab: Drug Atezolizumab
Carboplatin: Drug Carboplatin
Study summary
An open-label, multicenter study of ZL-1310 as a single agent and in combination with Atezolizumab (with and without Carboplatin) to evaluate the safety, efficacy, and pharmacokinetics in subjects with small cell lung cancer
Eligibility
Primary outcome measure(s)
- Incidence of Dose Limiting Toxicities of ZL-1310 as a single agent (Part 1A), in combination with Atezolizumab (Part 1B), and in combination with atezolizumab and carboplatin (Part 1C) — up to 24 months
Number of subjects with Dose Limiting Toxicities (DLTs) - Incidence of Treatment Emergent Adverse-Events of ZL-1310 as a single agent (Part 1A), in combination with atezolizumab (Part 1B), and in combination with atezolizumab and carboplatin (Part 1C) — up to 24 months
Number of subjects with treatment-emergent adverse events (TEAEs) - Incidence of Serious Adverse Events of ZL-1310 as a single agent (Part 1A), in combination with atezolizumab (Part 1B), and in combination with atezolizumab and carboplatin (Part 1C) — up to 24 months
Number of subjects with serious adverse events - Incidence of Treatment Emergent Adverse Events of ZL-1310 as a single agent (Part 2), in combination with atezolizumab (Part 3) and in combination with atezolizumab and carboplatin (Part 4) — up to 24 months
Number of subjects with treatment emergent adverse events leading to dose modifications and/or study treatment discontinuation - Incidence of Serious Adverse-Events (SAEs) of ZL-1310 as a single agent (Part 2), in combination with atezolizumab (Part 3), and in combination with atezolizumab and carboplatin (Part 4) — up to 24 months
Number of subjects with serious adverse events - Antitumor activity per RECIST v1.1 by investigator's assessment of ZL-1310 as a single agent (Part 2), in combination with atezolizumab (Part 3), and in combination with atezolizumab and carboplatin (Part 4) — up to 24 months
antitumor activity per RECIST v1.1 by investigator's assessment - Objective response rate (ORR) per RECIST v1.1 of ZL-1310 as a single agent (Part 2) and in combination with atezolizumab and carboplatin (Part 4) — up to 24 months
objective response rate per RECIST v1.1 - Disease control rate (DCR) per RECIST v1.1 of ZL-1310 in combination with atezolizumab — up to 24 months
disease control rate per RECIST v1.1
Trial sites (41)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope | Duarte | California | Withdrawn |
| Yale Cancer Center | New Haven | Connecticut | Recruiting |
| Sarah Cannon Research Institute | Sarasota | Florida | Recruiting |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | Recruiting |
| Hackensack University Medical Center | Hackensack | New Jersey | Recruiting |
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | Recruiting |
| Duke University | Durham | North Carolina | Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | Recruiting |
| University of Pittsburgh Hillman Cancer Center | Pittsburgh | Pennsylvania | Recruiting |
| Medical University of South Carolina | Charleston | South Carolina | Recruiting |
| NEXT Virginia | Fairfax | Virginia | Recruiting |
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | Recruiting |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | Recruiting |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | Withdrawn |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | Recruiting |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | Withdrawn |
| Henan Cancer Hospital | Zhengzhou | Henan | Recruiting |
| Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology | Wuhan | Hubei | Recruiting |
| Hunan Cancer Hospital | Changsha | Hunan | Withdrawn |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu | Terminated |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | Terminated |
| Jilin Cancer Hospital | Ch’ang-ch’un | Jilin | Active Not Recruiting |
| Liaoning Cancer Hospital & Institute | Shenyang | Liaoning | Withdrawn |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | Withdrawn |
| Affiliated Cancer Hospital of Shandong First Medical University | Jinan | Shandong | Recruiting |
| Zhongshan Hospital Fudan University | Shanghai | Shanghai Municipality | Recruiting |
| Sichuan Cancer Hospital | Chengdu | Sichaun | Recruiting |
| Rabin Medical Center | Petah Tikva | Central District | Recruiting |
| The Chaim Sheba Medical Center | Ramat Gan | Central District | Recruiting |
| Tel Aviv Sourasky Medical Center Ichilov | Tel Aviv | Tel Aviv | Recruiting |
| Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON | Barcelona | Barcelona | Recruiting |
| Hospital Universitario Ramon y Cajal | Madrid | Madrid | Recruiting |
| Hospital Universitario 12 de Octubre | Madrid | Madrid | Recruiting |
| Hospital Universitario Virgen Macarena | Seville | Sevilla | Recruiting |
| Hospital Clinico Universitario de Valencia | Valencia | Valencia | Recruiting |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | Valencia | Recruiting |
| START Barcelona_HM Nou Delfos | Barcelona | Spain | Recruiting |
| START MADRID_Hospital Universitario HM Sanchinarro | Madrid | Spain | Recruiting |
| Hospital Regional Universitario de Malaga - Hospital General H | Málaga | Spain | Recruiting |
| NEXT Oncology - Hospital Quironsalud Madrid | Pozuelo de Alarcón | Spain | Recruiting |
+ 1 more sites — see the full list on the official registry below.
On this site
📄 Tecentriq (atezolizumab) drug profile →Other trials for the same condition
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 NCT06179069 on ClinicalTrials.gov ↗ ← All trials in Israel