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| Name | Class |
|---|---|
| Dizal Pharmaceuticals | INDUSTRY |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Dose escalation | Experimental | Dose escalation part Golidocitinib in combination with sintilimab |
|
| Part B Dose expansion cohort 1 (PD-L1 TPS ≥ 50%) | Experimental | Dose expansion cohort 1, Golidositinib plus Sintilimab following Sintilimab |
|
| Part B Dose expansion cohort 2 (PD-L1 TPS 1-49%) | Experimental | Dose expansion cohort 2, Golidositinib plus Sintilimab following Sintilimab + chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golidocitinib | Drug | Daily dosing of golidocitinib |
|
| 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 |
| 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. |
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Inclusion Criteria:
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:
Exclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Wang, MD,PhD | Contact | 010-87788219 | zlhuxi@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jie Wang, MD,PhD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China |
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| Sintilimab | Drug | Sintilimab, 200mg, intravenous, every 3 weeks. |
|
| platinum doublet chemotherapy | Drug | Pemetrexed or nab-paclitaxel +carboplatin, intravenous, every 3 weeks for 2 cycles |
|
| through study completion, up to 36 months |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
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