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To determine the optimal objective response rate (ORR) of tislelizumab combined with albumin-bound paclitaxel and platinum agents in patients with KRAS-mutant lung cancer who are ineligible for curative surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KRAS-mutated lung cancer | KRAS mutation-positive lung cancer not amenable to radical surgery, treated with tislelizumab in combination with nab-paclitaxel and platinum chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tislelizumab in combination with nab-paclitaxel and platinum chemotherapy | Drug | Unresectable KRAS mutation-positive lung cancer receiving tislelizumab plus nab-paclitaxel and platinum-based chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate (ORR) | ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | The time from the enrollment date until death from any cause. | Up to approximately 5 years |
| AE | AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with KRAS-mutant, non-small cell lung cancer (NSCLC) who are ineligible for curative surgery; or patients with mixed small cell lung cancer (SCLC) containing an NSCLC component
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China |
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| Up to approximately 2 years |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| C520255 | 130-nm albumin-bound paclitaxel |
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