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

Non-Small-Cell Lung Cancer Clinical Trial

— JACKPOT33  

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%)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06198907
• Other study ID #: DZ2023J0002
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 2024
• Est. completion date: December 2027

Study information

• Verified date: December 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Jie Wang, MD,PhD
• Phone: 010-87788219
• Email: zlhuxi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 69
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Dizal Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Overall survival (OS)	time from first administration of study drug to death	through study completion, up to 36 months
Secondary	Incidence of Adverse Events	Frequency an severity of AEs according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	through study completion, up to 36 months