Real-world First-line Sugemalimab-Chemotherapy in Advanced NSCLC
ConditionNSCLC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years.
Patients voluntarily join the study and sign an informed consent form for the study.
ECOG PS score 0-3 (patients with PS score 2-3 would be enrolled if due to the tumor disease and anticipated to be improved at investigators' decision).
Histologically documented, stage III, IV non-Small Cell Lung Cancer (according to version 8th of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and previously untreated systematically(excluding local therapy for local lesions or symptomatic relief, palliative radiotherapy, intervention, intrathecal injection, nerve block, etc.).
Disqualifiers
All patients carry activating mutations of EGFR, ALK, ROS1, and RET. (No more mutation test needed).
Small cell lung cancer (including patients with mixed small cell lung cancer and non-small cell lung cancer).
Histopathologically or cytopathologically confirmed non-NSCLC.
Any prior treatment of antibody/drug that targets T-cell coregulatory proteins (not limited to CTLA-4 inhibitors or other agents targeting T cells).
Trial design
Design model
Parallel
Treatments tested in this trial
Sugemalimab and Chemotherapy
DrugSugemalimab 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chemotherapy as first-line therapy, followed by Sugemalimab 1200mg to 35 cycles, or until disease progression, or ICF withdrawn by participants, or death or unacceptable toxicity.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: stage IV NSCLC.Experimental treatment 1 intervention
Group B: stage III NSCLC.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
rw-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 yearSecondary outcomes
1
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 year2
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 year3
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 year4
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 yearSponsors and contacts
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Source ClinicalTrials.gov