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 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT07110103
Brief Summary:
This is an open-label, single-arm, phase 2 study to evaluate the safety and efficacy of golidocitinib with PD-1 inhibitors as maintenance treatment in patients with previously untreated extensive-stage small cell lung cancer.
Detailed Description:
This study is a single-arm clinical study to evaluate the safety and efficacy of golidocitinib combined with PD-1 inhibitors in ES-SCLC. The study consists of two parts:
Part A (dose escalation), which will include previously untreated ES-SCLC subjects, aims to explore the safety and tolerability of golidocitinib combined with PD-1 inhibitors in this population and determine the recommended dose of the combination.
Part B (dose expansion), which will include previously untreated ES-SCLC subjects, aims to explore the preliminary efficacy of golidocitinib combined with PD-1 inhibitors in this population and evaluate the efficacy and safety.
After completing the required assessments during the screening period and meeting the eligibility criteria, the subjects will first receive 4 cycles of PD-1 inhibitor combined with chemotherapy in the induction phase, followed by maintenance treatment with PD-1 inhibitor combined with golidocitinib. Subjects will continue to receive PD-1 inhibitor combined with golidocitinib until disease progression, intolerable toxicity, death, withdrawal of informed consent by the subject, or 24 months of treatment.
Study:
NCT07110103
Study Brief:
Protocol Section:
NCT07110103