Golidocitinib in Combination With Sintilimab for PD-L1 Selected Treatment Locally Advanced or Metastatic Non-Small Cell Lung Cancer(NSCLC) (JACKPOT33)

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%)

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Non-Small-Cell Lung Cancer
• Intervention / Treatment: Drug: Golidocitinib; Drug: Sintilimab; Drug: platinum doublet chemotherapy

• Study Type: Interventional
• Enrollment (Estimated): 69
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jie Wang, MD,PhD; Phone Number: 010-87788219; Email: zlhuxi@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
      • Contact: Jie Wang, MD, PhD; Phone Number: 010-87788219; Email: zlhuxi@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A Dose escalation; Dose escalation part Golidocitinib in combination with sintilimab	Drug: Golidocitinib; Daily dosing of golidocitinib; Drug: Sintilimab; Sintilimab, 200mg, intravenous, every 3 weeks.
Experimental: Part B Dose expansion cohort 1 (PD-L1 TPS ≥ 50%); Dose expansion cohort 1, Golidositinib plus Sintilimab following Sintilimab	Drug: Golidocitinib; Daily dosing of golidocitinib; Drug: Sintilimab; Sintilimab, 200mg, intravenous, every 3 weeks.
Experimental: Part B Dose expansion cohort 2 (PD-L1 TPS 1-49%); Dose expansion cohort 2, Golidositinib plus Sintilimab following Sintilimab + chemotherapy	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	time from first administration of study drug to death	through study completion, up to 36 months
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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: Dizal Pharmaceuticals
• Investigators: Principal Investigator: Jie Wang, MD,PhD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 28, 2023
• First Submitted That Met QC Criteria: December 28, 2023
• First Posted (Actual): January 10, 2024

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: DZ2023J0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No