Clinical trial NCT06198907: Golidocitinib in Combination With Sintilimab for PD-L1 Selected Treatment Locally Advanced or Metastatic Non-Small Cell Lung Cancer(NSCLC)
Official title: A Phase 2, Open-label, Single Arm Study to Investigate the Safety and Efficiency of Golidocitinib in Combination With Sintilimab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With PD-L1TPS ≥ 1%)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Non-Small-Cell Lung Cancer
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Dizal Pharmaceuticals
First posted: 2024-01-10
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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)

Primary outcomes:
measure: Overall response rate (ORR) (cohort1)
timeFrame: through study completion, an average of 1 year
measure: Progression-free survival (PFS) (cohort2)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: through study completion, up to 36 months
measure: Incidence of Adverse Events
timeFrame: through study completion, up to 36 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Jie Wang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: