Non-Small-Cell Lung Cancer
Conditions
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)
Interventions
DRUGGolidocitinib
Daily dosing of golidocitinib
DRUGSintilimab
Sintilimab, 200mg, intravenous, every 3 weeks.
Pemetrexed or nab-paclitaxel +carboplatin, intravenous, every 3 weeks for 2 cycles
Sponsors
Dizal Pharmaceuticals
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactJie Wang, MD,PhD
Outcome results
None listed