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Not yet recruiting NCT06198907

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

Phase II Interventional Non-Small-Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Golidocitinib, Sintilimab, platinum doublet chemotherapy.
Who it may be relevant to
Registry conditions: Non-Small-Cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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%)

Overview

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

  • Drug Golidocitinib
    Daily dosing of golidocitinib
  • Drug Sintilimab
    Sintilimab, 200mg, intravenous, every 3 weeks.
  • Drug platinum doublet chemotherapy
    Pemetrexed or nab-paclitaxel +carboplatin, intravenous, every 3 weeks for 2 cycles

Primary outcome measures

  • Overall response rate (ORR) (cohort1) [Time frame: through study completion, an average of 1 year]
  • Progression-free survival (PFS) (cohort2) [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (2)
  • Overall survival (OS) [Time frame: through study completion, up to 36 months]
  • Incidence of Adverse Events [Time frame: through study completion, up to 36 months]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing

Identifiers

NCT: NCT06198907 · DZ2023J0002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗