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

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

NCT ID: NCT06198907

Condition: Non-Small-Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Golidocitinib
Description: Daily dosing of golidocitinib
Arm group label: Part A Dose escalation
Arm group label: Part B Dose expansion cohort 1 (PD-L1 TPS ≥ 50%)
Arm group label: Part B Dose expansion cohort 2 (PD-L1 TPS 1-49%)

Intervention type: Drug
Intervention name: Sintilimab
Description: Sintilimab, 200mg, intravenous, every 3 weeks.
Arm group label: Part A Dose escalation
Arm group label: Part B Dose expansion cohort 1 (PD-L1 TPS ≥ 50%)
Arm group label: Part B Dose expansion cohort 2 (PD-L1 TPS 1-49%)

Intervention type: Drug
Intervention name: platinum doublet chemotherapy
Description: Pemetrexed or nab-paclitaxel +carboplatin, intravenous, every 3 weeks for 2 cycles
Arm group label: Part B Dose expansion cohort 2 (PD-L1 TPS 1-49%)

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)

Criteria for eligibility:
Criteria:
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)

Gender: All

Gender based: Yes

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Address:
City: Beijing
Zip: 100021
Country: China

Contact:
Last name: Jie Wang, MD, PhD

Phone: 010-87788219
Email: zlhuxi@163.com

Start date: January 2024

Completion date: December 2027

Lead sponsor:
Agency: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class: Other

Collaborator:
Agency: Dizal Pharmaceuticals
Agency class: Industry

Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06198907