Golidocitinib in Combination With Sintilimab for PD-L1 Selected Treatment Locally Advanced or Metastatic Non-Small Cell Lung Cancer(NSCLC)

Phase 2

Not yet recruiting

• Conditions: Non-Small-Cell Lung Cancer
• Interventions: Drug: Golidocitinib; Drug: Sintilimab; Drug: platinum doublet chemotherapy

• Registration Number: NCT06198907
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary

This is a phase 2 Study to investigate the safety, tolerability, and anti-tumor activity of golidocitinib in combination with sintilimab as the front-line treatment for patients with metastatic PD-L1 positive non-small cell lung cancer (NSCLC)

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-28
• Study First Submitted QC: 2023-12-28
• Last Update Submitted: 2023-12-28
• Study Start: 2024-01
• Study First Posted: 2024-01-10
• Last Update Posted: 2024-01-10
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

1. Be able to provide a signed and dated, written informed consent.
2. Adults aged ≥18 to 75 years.
3. ECOG performance status 0-1.
4. Predicted life expectancy ≥ 12 weeks
5. Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC) , Stage IIIB/IIIC (not suitable for concomitant chemoradiotherapy) or Stage IV according to AJCC 8th
6. Without EGFR or ALK mutations.
7. Adequate bone marrow reserve and organ system functions.
8. Patients with stable and symptomatic brain metastasis (BM) can be enrolled.

Part A Dose escalation:

Patients must have relapsed after or been refractory/intolerant to ≥ 1 prior systemic therapy(ies) for NSCLC

Part B dose expansion:

1. At least one measurable lesion according to RECIST 1.1.
2. Previously systemic untreated for advanced disease.
3. PD-L1 TPS ≥ 50% (cohort 1), PD-L1 TPS 1-49% (cohort 2)

Exclusion Criteria

1. Histopathology confirmed a mixture of NSCLC and small-cell lung cancer
2. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
3. Prior malignancy within 5 years
4. History of organ transplantation or hematopoietic stem cell transplantation
5. Sever lung function decline or interstitial lung disease that has required oral or IV steroids
6. Active autoimmune disease requiring systemic therapy within 2 years
7. Immunodeficiency, or being treated with immunosuppressive therapy (including systemic glucocorticoid) within 7 days prior to the first dose of study treatment.
8. Active infections
9. Significant cardiac disorder
10. Other serious or uncontrolled systemic diseases assessed by the investigator.

Part A Dose escalation:

1. Prior systemic therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or stimulatory or synergistic T-cell receptor (CTLA-4、OX-40、CD137) within 4 weeks

Part B Dose Expansion:

1. Any prior systemic anti-tumor therapy
2. Prior systemic immunotherapy, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or stimulatory or synergistic T-cell receptor (CTLA-4、OX-40、CD137)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part B Dose expansion cohort 2 (PD-L1 TPS 1-49%)	platinum doublet chemotherapy	Dose expansion cohort 2, Golidositinib plus Sintilimab following Sintilimab + chemotherapy
Part B Dose expansion cohort 1 (PD-L1 TPS ≥ 50%)	Sintilimab	Dose expansion cohort 1, Golidositinib plus Sintilimab following Sintilimab
Part A Dose escalation	Sintilimab	Dose escalation part Golidocitinib in combination with sintilimab
Part A Dose escalation	Golidocitinib	Dose escalation part Golidocitinib in combination with sintilimab
Part B Dose expansion cohort 1 (PD-L1 TPS ≥ 50%)	Golidocitinib	Dose expansion cohort 1, Golidositinib plus Sintilimab following Sintilimab
Part B Dose expansion cohort 2 (PD-L1 TPS 1-49%)	Sintilimab	Dose expansion cohort 2, Golidositinib plus Sintilimab following Sintilimab + chemotherapy
Part B Dose expansion cohort 2 (PD-L1 TPS 1-49%)	Golidocitinib	Dose expansion cohort 2, Golidositinib plus Sintilimab following Sintilimab + chemotherapy

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) (cohort2)	through study completion, an average of 1 year	Time from first administration of study drug to first documented disease progression or death per investigator assessment according to RECIST 1.1
Overall response rate (ORR) (cohort1)	through study completion, an average of 1 year	Complete response (CR) or partial response (PR) per investigator assessment according to RECIST 1.1

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	through study completion, up to 36 months	time from first administration of study drug to death
Incidence of Adverse Events	through study completion, up to 36 months	Frequency an severity of AEs according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Trial Locations

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China