A Single-Arm, Phase Ⅰb Study of Golidocitinib Combined With Anti-PD-1 for the Treatment of Previously Treated NSCLC

NCT06690671 | Not Yet Recruiting Phase 1

• 1 other identifier: IS24147
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a phase Ib, single-center, single-arm exploratory clinical study designed to evaluate the safety and efficacy of Golidocitinib in combination with anti-PD-1 monoclonal antibody in locally advanced or metastatic NSCLC treated with anti-PD-1 in combination with or without platinum-containing chemotherapy regimens.

Conditions

Lung Cancer, Non-Small Cell

Keywords

JAKi; anti-PD-1; resitance

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  To assess Golidocitinib overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR)

  Time from first dose to last dose, or up to 24 month

Secondary Outcomes (4)

• Progression-free survival (PFS)

  Time from first subject dose to study completion, or up to 36 month

• Duration of Response (DoR)

  Time from first subject dose to study completion, or up to 36 month

• Overall survival (OS)

  Time from first subject dose to study completion, or up to 36 month

• Adverse events (AEs) according to CTCAE 5.0

  From first dose until 28 days after the last dose, up to 24 month

Study Arms (1)

Golidocitinib in combination with anti-PD-1

EXPERIMENTAL

Golidocitinib 150/75 mg once daily (QD) with anti-PD-1 （200 mg IV Q3W），21 days in one cycle.

Drug: Golidocitinib in combination with anti-PD-1

Interventions

Golidocitinib in combination with anti-PD-1 DRUG

Golidocitinib 150/75 mg once daily (QD) with anti-PD-1 （200 mg IV Q3W），21 days in one cycle.

Golidocitinib in combination with anti-PD-1

Eligibility Criteria

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

You may qualify if:

• be able to provide signed and dated informed consent, including adherence to the requirements and limitations listed in the Informed Consent Form (ICF) and in this protocol;
• be ≥ 18 years of age, male or female, at the time of signing the ICF;
• ECOG score of 0 or 1;
• life expectancy ≥ 3 months;
• patients with histologically or cytologically confirmed NSCLC diagnosed as locally advanced (Stage IIIB/IIIC), metastatic or recurrent (Stage IV) according to the International Association for the Study of Lung Cancer and the Joint Committee on the American Classification of Cancers, 8th edition of the TNM staging of lung cancer, who are not suitable for radical surgery or concurrent radiotherapy;
• prior treatment with a first-line regimen of PD-1 monoclonal antibody (including, but not limited to, navulizumab, pabolizumab, treprostinil, sindilizumab, karelizumab, tirilizumab, and pegfilgrastimab) in combination with or without first-line regimen of platinum-containing chemotherapy, with a best-case outcome of CR/PR/SD that lasts at least 6 weeks;
• intolerance to standard chemotherapy or refusal of chemotherapy;
• at least one measurable lesion (RECIST v1.1);
• adequate bone marrow reserve and organ system functional reserve, as summarized below:
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L under conditions not receiving growth factor support.
• Platelets ≥ 100 × 109/L under conditions of no growth factor support or transfusion.
• Hemoglobin ≥ 9 g/dL without transfusion or receiving erythropoietin.
• Total bilirubin ≤ 1.5 × ULN; if Gilbert syndrome (unconjugated hyperbilirubinemia) is present, total bilirubin should be ≤ 3 × ULN.
• ALT and AST ≤ 2.5 × ULN; for patients with documented liver metastases, AST and ALT levels ≤ 5 × ULN.
• Blood creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min calculated by the Cockcroft-Gault method, or urinary creatinine clearance ≥ 50 mL/min measured over 24 hours.

You may not qualify if:

• histopathologically confirmed presence of a mixture of NSCLC and small cell lung cancer components;
• the known presence of an EGFR-sensitive mutation/exon 20 insertion mutation or ALK/ROS1/RET fusion or MET14 jump mutation;
• the known presence of interstitial pneumonitis/immune pneumonitis or interstitial changes
• the known presence of spinal cord compression or meningeal metastases;
• a history of any of the following:
• Currently participating in an interventional clinical study treatment and any drug still in the developmental phase requiring a washout of 5 half-lives (or discuss with study team);
• Received palliative radiotherapy within 2 weeks prior to the first dose, for more than 30% of the bone marrow for radiotherapy or extensive radiotherapy, which needs to be completed within 4 weeks prior to the first dose;
• Currently receiving (or unable to discontinue use of) medications, herbal supplements, and foods known to be potent inducers or potent inhibitors of CYP3A at least 1 week prior to first dose;
• Presence of an adverse event due to prior therapy via CTCAE \> Grade 1 (with the exception of any degree of alopecia) prior to the first dose;
• Known serious hematologic adverse event caused by a drug on prior first-line therapy that does not recover within 7 days to a Common Criteria for Terminology of Adverse Events (CTCAE) 5.0 rating of 2 or less.
• receipt of a solid organ or hematologic transplant (e.g., previous allogeneic bone marrow transplant or whole blood transfusion within 120 days of sample collection during the study period)
• subjects with severe pulmonary function decline (i.e., any FEV1 or DLCO \< 60% of predicted). Prior interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid hormone therapy or current clinically active interstitial lung disease (including interstitial changes in the lungs), immunotherapy-induced immune pneumonitis of degree 3 or greater or resulting in treatment termination;
• active autoimmune disease requiring systemic therapy (e.g., use of disease-mitigating drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency, etc.) are not considered systemic therapy;
• physiologic doses of glucocorticoids (≤10 mg/day of prednisone or equivalent) are permitted for a diagnosis of immunodeficiency or if systemic glucocorticoid therapy or any other form of immunosuppressive therapy is being received within 7 days prior to the first dose of the study;
• diagnosis of another malignancy within 5 years prior to the first dose, with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ that has been evaluated and clinically cured;

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

241, West Huaihai Road, Shanghai, Shanghai, Shanghai 200030

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Hua Zhong, MD

CONTACT

+86-021-22200000; eddiedong8@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 15, 2024
• Study Start: December 15, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)