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

NCT07110103 | Recruiting Phase 2

• 1 other identifier: NCC5342
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

SCLC; SCLC, Extensive Stage

Keywords

golidocitinib; ES-SCLC

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  Time from the subject started treatment to disease progression or death due to any cause based on the investigators' evaluation

  From enrollment to the end of monitoring at 2 years

Secondary Outcomes (2)

• Overall Survival (OS)

  From enrollment to the end of monitoring at 2 years

• Safety and Tolerability

  From enrollment to the end of monitoring at 2 years

Study Arms (1)

golidocitinib with PD-1 inhibitors

EXPERIMENTAL

Patients will firstly receive 4 cycles of PD-1 inhibitors and chemotherapy as induction treatment, and patients who don't progress during induction period will continue to receive golidocitinib with PD-1 inhibitors as maintenance treatment until disease progression.

Drug: golidocitinib with PD-1 inhibitors

Interventions

golidocitinib with PD-1 inhibitors DRUG

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.

Also known as: AZD4205

golidocitinib with PD-1 inhibitors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide a signed and dated informed consent form, including compliance with the requirements and restrictions listed in the ICF and this protocol;
• Subjects are ≥ 18 years old when signing the ICF;
• Subjects have an ECOG performance status score of 0 or 1 and have not deteriorated in the past 2 weeks;
• Life expectancy ≥ 3 months;
• Histologically or cytologically confirmed ES-SCLC (stage IV \[any T stage, any N stage, M1 a/b/c stage\] according to the 8th edition of the AJCC TNM staging system for lung cancer, or T3-4 stage disease caused by multiple lung nodules and the disease is too diffuse, or the tumor/nodule volume is too large to be tolerated by a tolerable radiotherapy plan);
• The presence of at least one measurable lesion (based on RECIST 1.1): with a long diameter ≥ 10 mm (lymph node lesions require a short diameter of ≥15 mm) that can be accurately and repeatedly measured at baseline under CT or MRI; and there are measurable lesions outside the central nervous system;
• SCLC patients who have not received any systemic anti-tumor treatment for advanced disease; if the patient has received neoadjuvant/adjuvant therapy in the past, the interval between the diagnosis of ES-SCLC and the completion of the last treatment must be at least 6 months;
• Patients must be suitable for platinum (cisplatin or carboplatin)-based chemotherapy as the first-line treatment for ES-SCLC;
• Adequate bone marrow reserve and organ system function reserve, summarized as follows:
• Absolute neutrophil count (ANC) ≥ 1.5×109/L without growth factor support;
• Platelet ≥ 100×109/L without growth factor support or blood transfusion;
• Hemoglobin ≥ 9 g/dL or 90 g/L without erythropoietin or blood transfusion;
• Total bilirubin ≤ 1.5 × ULN; if suffering from Gilbert syndrome (unconjugated hyperbilirubinemia), total bilirubin should be ≤ 3 × ULN;
• ALT and AST ≤ 2.5 × ULN. For patients with documented liver metastases, AST and ALT levels ≤ 5 × ULN;
• Creatinine clearance calculated by the Cockcroft-Gault method, \>60 ml/min for patients receiving cisplatin and \>45 ml/min for patients receiving carboplatin;

You may not qualify if:

• Histopathological confirmation of the presence of mixed NSCLC and SCLC components;
• The presence of spinal cord compression or meningeal metastasis;
• Any of the following medical histories:
• Systemic treatment with Chinese patent medicines with anti-lung cancer indications or immunomodulatory drugs (including thymosin, interferon, interleukin, excluding local use for the control of pleural effusion) within 2 weeks before the first dose;
• Currently participating in interventional clinical research treatment, or receiving other research drugs or using research devices within 4 weeks before the first dose; any drug still in the development stage needs to be washed out for 5 half-lives (or discussed with the research team);
• Other major surgeries other than diagnosis or biopsy (excluding vascular access) within 4 weeks before the first dose, or major surgery is expected during the study;
• Palliative radiotherapy within 2 weeks before the first dose;
• Serious arterial/venous thrombotic events, including cerebrovascular accident (e.g., history of stroke or intracranial hemorrhage), deep vein thrombosis, and pulmonary embolism, occurred within 6 months before the first dose;
• Currently receiving (or unable to stop taking at least 1 week before the first dose) drugs, herbal supplements, and foods that are known to be strong inducers or inhibitors of CYP3A;
• Prior to the first dose, there was a CTCAE caused by previous treatment \> Grade 1 adverse events (except alopecia of any degree);
• Receiving solid organ or blood system transplantation (such as previous allogeneic bone marrow transplantation or whole blood transfusion within 120 days of sample collection during the study);
• Previous interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid hormone treatment, or current clinically active interstitial lung disease (including interstitial lung changes), immune pneumonitis caused by immunotherapy;
• Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, corticosteroids or immunosuppressants) within 2 years before the first dose. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment;
• Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of the study. Physiological doses of glucocorticoids (≤10 mg/day of prednisone or equivalent) are allowed;
• Diagnosed with other malignancies within 5 years before the first dose, excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been evaluated to be clinically cured;

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Dizal (Jiangsu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (2)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

Xinqiao Hospital, Third Military Medical University

Chongqing, China

RECRUITING

MeSH Terms

Interventions

Immune Checkpoint Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Zhijie Wang, MD, PhD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhijie Wang, MD, PhD

CONTACT

+86 010-67781331; jie_969@163.com

Boyang Sun

CONTACT

+8613002235072; boyangsun926@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 27, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)