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

NCT ID: NCT06198907

Last Updated: 2024-01-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2027-12-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A Dose escalation

Dose escalation part Golidocitinib in combination with sintilimab

Group Type: EXPERIMENTAL

Golidocitinib

Intervention Type: DRUG

Daily dosing of golidocitinib

Sintilimab

Intervention Type: DRUG

Sintilimab, 200mg, intravenous, every 3 weeks.

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

Dose expansion cohort 1, Golidositinib plus Sintilimab following Sintilimab

Group Type: EXPERIMENTAL

Golidocitinib

Intervention Type: DRUG

Daily dosing of golidocitinib

Sintilimab

Intervention Type: DRUG

Sintilimab, 200mg, intravenous, every 3 weeks.

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

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

Group Type: EXPERIMENTAL

Golidocitinib

Intervention Type: DRUG

Daily dosing of golidocitinib

Sintilimab

Intervention Type: DRUG

Sintilimab, 200mg, intravenous, every 3 weeks.

platinum doublet chemotherapy

Intervention Type: DRUG

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

Interventions

Golidocitinib

Daily dosing of golidocitinib

Intervention Type: DRUG

Sintilimab

Sintilimab, 200mg, intravenous, every 3 weeks.

Intervention Type: DRUG

platinum doublet chemotherapy

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

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dizal Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Jie Wang

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jie Wang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Jie Wang, MD,PhD

Role: CONTACT

zlhuxi@163.com

010-87788219

Facility Contacts

Jie Wang, MD, PhD

Role: primary

zlhuxi@163.com

010-87788219

Other Identifiers

DZ2023J0002

Identifier Type: -

Identifier Source: org_study_id