Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-30 @ 2:01 PM
Study NCT ID:
NCT07110103
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-07
First Post:
2025-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Golidocitinib With PD-1 Inhibitors as Maintenance Treatment for Previously Untreated ES-SCLC
Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Organization:
Study Overview
Official Title:
Golidocitinib With PD-1 Inhibitors as Maintenance Treatment in Patients With Previously Untreated Extensive-stage Small Cell Lung Cancer: an Open-label, Single-arm, Phase 2 Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JACKPOT38
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: