This is a prospective, single arm, multicenter phase II study aimed at evaluating the efficacy and safety of Envafolimab combined with standard platinum containing dual drug chemotherapy and Recombinant Human Endostatin in patients with advanced (stage IIIB-IV) squamous non-small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Envafolimab: 300 mg,D1,Q3W,until PD or intolerable toxicity Chemotherapy: Paclitaxel / NAB-Paclitaxel, 175 / 260mg / m2, D1, Q3w; Cisplatin: 75mg / m2, 1-3 days, or carboplatin: AUC 5, D1, Q3w, 4-6 cycles in total. Recombinant Human Endostatin:210mg,CIV 72h,d1-3,Q3W,4-6 cycles in total.
Qilu hospital of Shandong univertisy
Jinan, Shandong, China
RECRUITINGShandong Cancer Hospital
Jinan, China
NOT_YET_RECRUITING1 year PFS rate
12-month progression free survival in ITT population
Time frame: 12 months after the last subject participating in
ORR
The proportion of subjects with complete response (CR) and partial response (PR) in total subjects
Time frame: 24 months after the last subject participating in
DOR
DoR (per RECIST 1.1) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.
Time frame: 24 months after the last subject participating in
PFS
Progression-free survival (PFS per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first
Time frame: 24 months after the last subject participating in
OS
OS is defined as the time from the starting date of study drug to the date of death due to any cause.
Time frame: 24 months after the last subject participating in
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