Small Cell Lung Cancer, Neuroendocrine Carcinoma
Conditions
Brief summary
This study is a randomized, multicenter, Phase Ib/II clinical trial, aimed at evaluating the efficacy and safety of the combination of ZG006 and ZG005 in patients with advanced small cell lung cancer and neuroendocrine carcinoma.
Interventions
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Fully understand the study and voluntarily sign the informed consent form. * Male or female 18-70 years of age. * Participants with advanced small cell lung cancer or neuroendocrine carcinoma confirmed by histopathology or cytology. * Eastern Cooperative Oncology Group (ECOG) 0 to 1. * Life expectancy \> 3 months.
Exclusion criteria
* The investigator believes that the subject has other reasons that make them unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced Dose-limiting Toxicity (DLT) | up to 28 days | — |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to 2 years | — |
| Objective Response Rate (ORR) | Up to 2 years | The objective response rate was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) based on the modified RECIST v1.1. |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response (DOR) | Up to 2 years |
| Overall Survival (OS) | Up to 2 years |
| Disease Control Rate (DCR) | Up to 2 years |
| Progression-free Survival (PFS) | Up to 2 years |
Countries
China
Contacts
Primary ContactHewen Yin
Outcome results
None listed