RecruitingPhase 2NCT07110103

Golidocitinib With PD-1 Inhibitors as Maintenance Treatment for Previously Untreated ES-SCLC

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


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

20 participants

Start Date

Oct 31, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether golidocitinib (a JAK inhibitor that blocks certain immune signals) combined with a PD-1 immunotherapy drug can help maintain remission after first-line chemotherapy in people with extensive-stage small cell lung cancer (SCLC). SCLC is an aggressive type of lung cancer and better maintenance strategies are urgently needed. **You may be eligible if...** - You have extensive-stage small cell lung cancer (stage IV or widely spread disease) - You have not received any prior systemic treatment for advanced disease - You are in good physical condition (ECOG 0-1) with life expectancy of at least 3 months - You have at least one measurable tumor lesion outside the brain - If you had prior neoadjuvant/adjuvant therapy, it was completed a sufficient time ago **You may NOT be eligible if...** - You have received prior systemic treatment for your advanced SCLC - You have active brain metastases requiring treatment - You have significant autoimmune disease or are on immunosuppressants - Your organ function does not meet required levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGgolidocitinib with PD-1 inhibitors

Dose escalation: 75/150mg golidocitinib with PD-1 inhibitors as maintenance treatment after 4 cycles of PD-1 inhibitors and chemotherapy. Dose expansion: Selected dose (75mg or 150mg) of golidocitinib with PD-1 inhibitors as maintenance treatment after 4 cycles of PD-1 inhibitors and chemotherapy.


Locations(2)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

Xinqiao Hospital, Third Military Medical University

Chongqing, China

View Full Details on ClinicalTrials.gov

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NCT07110103


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