Status:
NOT_YET_RECRUITING
Golidocitinib in Combination With Sintilimab for PD-L1 Selected Treatment Locally Advanced or Metastatic Non-Small Cell Lung Cancer(NSCLC)
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborating Sponsors:
Dizal Pharmaceuticals
Conditions:
Non-Small-Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Be able to provide a signed and dated, written informed consent.
- Adults aged ≥18 to 75 years.
- ECOG performance status 0-1.
- Predicted life expectancy ≥ 12 weeks
- 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
- Without EGFR or ALK mutations.
- Adequate bone marrow reserve and organ system functions.
- 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:
- At least one measurable lesion according to RECIST 1.1.
- Previously systemic untreated for advanced disease.
- PD-L1 TPS ≥ 50% (cohort 1), PD-L1 TPS 1-49% (cohort 2)
Exclusion
- Histopathology confirmed a mixture of NSCLC and small-cell lung cancer
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Prior malignancy within 5 years
- History of organ transplantation or hematopoietic stem cell transplantation
- Sever lung function decline or interstitial lung disease that has required oral or IV steroids
- Active autoimmune disease requiring systemic therapy within 2 years
- Immunodeficiency, or being treated with immunosuppressive therapy (including systemic glucocorticoid) within 7 days prior to the first dose of study treatment.
- Active infections
- Significant cardiac disorder
- 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:
- Any prior systemic anti-tumor therapy
- 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)
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT06198907
Start Date
January 1 2024
End Date
December 1 2027
Last Update
January 10 2024
Active Locations (1)
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1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021