Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-24 @ 5:21 PM
NCT ID:
NCT05685550
Brief Summary:
This study aims to explore the safety and efficacy of etoposide capsules combined with Anlotinib and Envafolimab in elderly patients with extensive small cell lung cancer.This is a single-center, single-arm exploratory clinical study. 30 patients with extensive small-cell lung cancer are scheduled to be enrolled. Treatment regimen is etoposide capsule 100mg PO qd\*7d, Anlotinib 12mg PO qd\*14d, Envafolimab 300mg/ IH Q3W. Based on the safety and other data from the subjects, the combination regimen was administered for 4 to 6 cycles, with a maximum of 6 cycles. In principle, at least 4 cycles were required unless chemotherapy-related toxicity necessitated early termination. Subsequently, patients without evidence of disease progression received maintenance therapy with envolumab plus anlotinib until disease progression, intolerable adverse events, or death.
Detailed Description:
The primary objective of this study was to explore the safety and median PFS of etoposide capsules combined with Anlotinib and Envafolimab as first-line treatment in elderly patients with extensive small-cell lung cancer (as assessed by the investigators according to RECIST 1.1 criteria).The secondary objective of this study was to evaluate the OS, ORR, and QOL of etoposide capsules combined with Envafolimab and Anlotinib as first-line treatment in elderly patients with extensive small-cell lung cancer.Exploratory aims are to explore predictive or prognostic biomarkers (tissue and/or plasma) associated with therapeutic response or resistance to disease; Analysis of potential biomarkers in biopsy tissue samples and blood samples after disease progression to explore possible mechanisms of therapeutic resistance. To provide a better treatment plan for elderly patients with extensive small cell lung cancer.
Study:
NCT05685550
Study Brief:
Protocol Section:
NCT05685550