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This study is a randomized, open-label, controlled, multicenter Phase III clinical trial to evaluate the efficacy and safety of SHR-8068 combined with adebrelimab and platinum-based chemotherapy versus tislelizumab combined with platinum-based chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-8068,adebelizumab and platinum-based chemotherapy | Experimental |
| |
| tislelizumab, and platinum-based chemotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-8068,adebelizumab and platinum-based chemotherapy | Drug | SHR-8068,adebelizumab and platinum-based chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) by Blinded Independent Central Review [BICR] | PFS (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1]) by BICR was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression) | Approximately 32 months. |
| OS | OS was defined as the time from the date of randomization until death due to any cause. | Approximately 64 months. |
| Measure | Description | Time Frame |
|---|---|---|
| PFS by the investigator | PFS (per RECIST 1.1) by the investigator was defined as time from date of randomization until date of objective disease or death (by any cause in the absence of progression) | Approximately 32 months. |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weixia Li | Contact | +86 021-61053363 | weixia.li@hengrui.com | |
| Yang Wang | Contact | +86 021-61053363 | yang.wang.yw263@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Cancer Hospital of Shandong First Medical University | Recruiting | Jinan | Shandong | 250117 | China |
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| tislelizumab, and platinum-based chemotherapy | Drug | tislelizumab, and platinum-based chemotherapy |
|
ORR (per RECIST 1.1) by BICR or the investigator was defined as the percentage of patients with at least one visit response of complete response (CR) or partial response (PR). |
| Approximately 32 months. |
| Duration of Response (DoR) | DoR (per RECIST 1.1) by BICR or the investigator was defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression. | Approximately 32 month |
| Incidence and Severity of Adverse Events (AEs) | Incidence and severity of treatment emergent adverse events (TEAEs) will be reported. Any adverse event occurring at or after the initial administration of study treatment through the day of last dose plus 60 days, or until the start of subsequent anticancer therapy (if earlier), is considered to be treatment emergent. | Approximately 64 months. |
| Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ C30-Lung Cancer Module 13 (QLQ-LC13) | The EORTC QLQ-LC13 is a disease-specific 13-item self-administered questionnaire for lung cancer, to be used in conjunction with the EORTC QLQ-C30. It comprises both multi-item and single-item measures of lung cancer-associated symptoms and treatment-related symptoms from conventional chemotherapy and radiotherapy. Scores from 0 to 100 were derived for each symptom item, with higher scores representing greater level of symptoms. Time to deterioration was defined as time from randomization until the date of first clinically meaningful deterioration that was confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration. | Approximately 64 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 |
|---|---|
| D017671 | Platinum Compounds |
| C000707970 | tislelizumab |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
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