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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
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chemotherapy as first-line therapy, followed by Sugemalimab 1200mg to 35 cycles, or until disease progression, or ICF withdrawn by participants, or death or unacceptable toxicity.
cancer hospital, Chinese Academy of medical sciences and Peking union medical college
Beijing, Beijing Municipality, China
RECRUITINGrw-PFS
rw-PFS, defined as the time from the start of 1st line treatment to tumor progression or death, which occurs first
Time frame: From enrollment to the end of treatment at 1 year
TTF
time from the start of the first dose of first-line therapy to treatment failure due to any cause.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 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.
Time frame: Up to 24 months from treatment initiation (with OS rates assessed at 12, 18, and 24 months)