Actively Recruiting
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
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-02-27
20
Participants Needed
2
Research Sites
65 weeks
Total Duration
On this page
Sponsors
C
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead Sponsor
D
Dizal (Jiangsu) Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of golidocitinib combined with PD-1 inhibitors as a maintenance treatment for patients with previously untreated extensive-stage small cell lung cancer (ES-SCLC). This is an open-label, single-arm phase 2 study that aims to determine the recommended dose and preliminary efficacy of this combination treatment in this patient population. The study has two parts: Part A explores the safety and dose tolerance of golidocitinib with PD-1 inhibitors, while Part B assesses the preliminary effectiveness and safety of the selected dose. Participants first receive 4 cycles of PD-1 inhibitors combined with chemotherapy during an induction phase. Those without disease progression then continue with maintenance treatment using the combination of golidocitinib and PD-1 inhibitors. Treatment may continue until disease progression, unacceptable side effects, death, withdrawal of consent, or completion of 24 months. Participants will undergo screening assessments to confirm eligibility before starting treatment. During the study, researchers will monitor progression-free survival over a 2-year period as the primary outcome. Other measures include overall survival and safety assessments. Participants will have regular evaluations including laboratory tests, imaging scans, and clinical examinations to track treatment effects and side effects throughout the study duration.
CONDITIONS
Brief Title
Golidocitinib With PD-1 Inhibitors as Maintenance Treatment for Previously Untreated ES-SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide signed informed consent and comply with study requirements
- 18 years of age or older at consent
- ECOG performance status of 0 or 1 and stable for at least 2 weeks
- Life expectancy of 3 months or longer
- Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC)
- At least one measurable lesion outside the central nervous system
- No prior systemic anti-tumor treatment for advanced ES-SCLC
- Suitable for platinum-based chemotherapy as first-line treatment
- Adequate bone marrow and organ function as specified
- If central nervous system metastases present, must meet stability criteria
- Negative pregnancy test for women of childbearing potential and agreement to use contraception
- Ability to understand and comply with study procedures
- Suitable for starting maintenance treatment with golidocitinib and PD-1 inhibitors as judged by investigator
You will not qualify if you...
- Mixed non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) components
- Presence of spinal cord compression or meningeal metastasis
- Recent systemic treatment with certain anti-lung cancer or immunomodulatory drugs
- Participation in other clinical trials or use of investigational drugs within specified time
- Major surgery or palliative radiotherapy within specified time before study
- Recent serious thrombotic events within 6 months
- Use of drugs that strongly affect CYP3A within 1 week before first dose
- Previous grade >1 adverse events from prior treatments (except alopecia)
- History of organ or blood system transplantation within 120 days
- Current or prior interstitial lung disease or immune pneumonitis
- Active autoimmune disease requiring systemic treatment within 2 years
- Immunodeficiency or recent immunosuppressive therapy
- Other malignancies diagnosed within 5 years (with exceptions)
- Live vaccination within 30 days before first dose
- Known active tuberculosis or uncontrolled infections
- Active infections including hepatitis B, C, HIV, or COVID-19
- Significant cardiac conditions or abnormalities
- Allergy to study drugs or ingredients
- Severe gastrointestinal issues affecting drug absorption
- Pregnant or breastfeeding women
- Known bleeding disorders
- Severe or uncontrolled systemic diseases that may affect study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of 4 treatment cycles
Participants receive 4 cycles of PD-1 inhibitors combined with chemotherapy.
4 treatment visits
Duration - Up to 24 months
Participants receive maintenance treatment with golidocitinib combined with PD-1 inhibitors until disease progression, intolerable toxicity, death, withdrawal, or 24 months of treatment.
Regular visits during maintenance treatment
Trial Site Locations
Total: 2 locations
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
2
Xinqiao Hospital, Third Military Medical University
Chongqing, China
Actively Recruiting
Research Team
Z
Zhijie Wang, MD, PhD
B
Boyang Sun
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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