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

NCT06198907 | Not Yet Recruiting Phase 2

• 1 other identifier: DZ2023J0002
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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)

Conditions

Non-Small-Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Overall response rate (ORR) (cohort1)

  Complete response (CR) or partial response (PR) per investigator assessment according to RECIST 1.1

  through study completion, an average of 1 year

• Progression-free survival (PFS) (cohort2)

  Time from first administration of study drug to first documented disease progression or death per investigator assessment according to RECIST 1.1

  through study completion, an average of 1 year

Secondary Outcomes (2)

• Overall survival (OS)

  through study completion, up to 36 months

• Incidence of Adverse Events

  through study completion, up to 36 months

Study Arms (3)

Part A Dose escalation

EXPERIMENTAL

Dose escalation part Golidocitinib in combination with sintilimab

Drug: Golidocitinib; Drug: Sintilimab

Part B Dose expansion cohort 1 (PD-L1 TPS ≥ 50%)

EXPERIMENTAL

Dose expansion cohort 1, Golidositinib plus Sintilimab following Sintilimab

Drug: Golidocitinib; Drug: Sintilimab

Part B Dose expansion cohort 2 (PD-L1 TPS 1-49%)

EXPERIMENTAL

Dose expansion cohort 2, Golidositinib plus Sintilimab following Sintilimab + chemotherapy

Drug: Golidocitinib; Drug: Sintilimab; Drug: platinum doublet chemotherapy

Interventions

Golidocitinib DRUG

Daily dosing of golidocitinib

Part A Dose escalation; Part B Dose expansion cohort 1 (PD-L1 TPS ≥ 50%); Part B Dose expansion cohort 2 (PD-L1 TPS 1-49%)

Sintilimab DRUG

Sintilimab, 200mg, intravenous, every 3 weeks.

Part A Dose escalation; Part B Dose expansion cohort 1 (PD-L1 TPS ≥ 50%); Part B Dose expansion cohort 2 (PD-L1 TPS 1-49%)

platinum doublet chemotherapy DRUG

Pemetrexed or nab-paclitaxel +carboplatin, intravenous, every 3 weeks for 2 cycles

Part B Dose expansion cohort 2 (PD-L1 TPS 1-49%)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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:
• \. 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)

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Dizal Pharmaceuticals: collaborator

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sintilimab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jie Wang, MD,PhD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Wang, MD,PhD

CONTACT

010-87788219; zlhuxi@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 10, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 10, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)