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This single-arm, multi-center study is to evaluate Sugemalimab plus platinum-based chemotherapy as first-line therapy for patients with locally advanced and metastatic NSCLC in a real-world setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stage IV NSCLC. | Experimental | Sugemalimab 1200mg plus 4-6 cycles of platinum-based chemotherapy |
|
| stage III NSCLC. | Experimental | sugemalimab+platinum-based chemotherapy in stage III NSCLC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugemalimab and Chemotherapy | Drug | Sugemalimab 1200mg plus 4-6 cycles of platinum-based chemotherapy as first-line therapy, followed by Sugemalimab 1200mg to 35 cycles, or until disease progression, or ICF withdrawn by participants, or death or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| rw-PFS | rw-PFS, defined as the time from the start of 1st line treatment to tumor progression or death, which occurs first | From enrollment to the end of treatment at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| TTF | time from the start of the first dose of first-line therapy to treatment failure due to any cause. | From enrollment to the end of treatment at 1 year |
| OS | OS defined as the time from the start of treatment to death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Junling doctor | Contact | +86 13801178891 | lijunling@cicams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| cancer hospital, Chinese Academy of medical sciences and Peking union medical college | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| ID | Term |
|---|---|
| C000723018 | sugemalimab |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| From enrollment to the end of treatment at 1 year |
| Objective response rate (ORR) | the proportion of patients with a complete response (CR) or a partial response (PR), as assessed by RECIST version 1.1 Subjects with measurable disease and CR or PR determined at least 4 weeks after initial CR or PR would be considered responders. | From enrollment to the end of treatment at 1 year |
| DCR | the proportion of patients with disease control (CR,PR or SD), as assessed by RECIST version 1.1 | From enrollment to the end of treatment at 1 year |
| DOR | For subjects who demonstrated CR or PR, duration of response (DOR) is defined as the time from first documented evidence of CR or PR until disease progression or death | From enrollment to the end of treatment at 1 year |
| Safety, number of participants with treatment-related adverse events (AEs) | Including treatment-emergent adverse reactions (AEs), drug-related AEs, serious adverse reactions (SAEs), and drug-related SAEs | From enrollment to the end of treatment at 1 year |
| 12-month, 18-month, and 24-month overall survival (OS) rates | The 12-, 18-, and 24-month overall survival (OS) rates are defined as the proportions of patients who are alive at 12, 18, and 24 months after treatment initiation, respectively. | Up to 24 months from treatment initiation (with OS rates assessed at 12, 18, and 24 months) |