This is a phase II clinical study to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetics of JS207 (anti-PD-1/VEGF bispecific antibody) combined with platinum-based doublet chemotherapy in subjects with stage II-III non-small cell lung cancer. The study consists of 2 cohorts, including treatment-naïve and resectable subjects with stage II-III NSCLC (cohort 1), treatment-naïve and unresectalbe subjects with stage III NSCLC (cohort 2). Subjects in both cohorts will receive 3 cycles of JS207 + platinum-based doublet chemotherapy as neoadjuvant therapy, followed by surgery or definitive chemoradiotherapy, and then adjuvant therapy with JS207 (post-surgery) or consolidation therapy with JS207 (post-chemoradiotherapy).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Carboplatin Injection: One dose of carboplatin AUC 5 IV on Day 1 of each 3-week cycle. Cisplatin injection: Cisplatin 75 mg/m2 IV on Day 1 of every 3-week cycle. Paclitaxel injection: 175 mg/m2 IV on Day 1 of each 3-week cycle. Pemetrexed Injection: Pemetrexed 500 mg/m2 IV on Day 1 of each 3-week cycle.
Subjects with surgical indications will undergo radical surgery for NSCLC,within 4-6 weeks after the last dose of neoadjuvant therapy.
If radical surgery is not suitable after MDT evaluation, the subjects will receive comprehensive treatment mainly based on radiotherapy.
JS207 will be administered every 3 weeks for a treatment cycle of 21 days.
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
PCR rate
To evaluate the pathologic complete response rate (pCR rate) of JS207 combined with platinum-based doublet chemotherapy in subjects with resectable stage II-III NSCLC and subjects with uresectable stage III NSCLC.
Time frame: 2 years
MPR rate
To evaluate the pathologic MPR rate of JS207 combined with platinum-based doublet chemotherapy in subjects with resectable stage II-III NSCLC and subjects with uresectable stage III NSCLC.
Time frame: 2 years
EFS
Time from the beginning of randomization until disease progression under the RECIST1.1 criteria is first recorded leading to inoperable or CRT, local progression leading to inoperable tumor resection or CRT, CRT or postoperative disease recurrence or progression, or death from any cause, whichever occurs first
Time frame: 2 years
ORR
Subjects with partial response (PR) or complete response (CR) at BOR
Time frame: 2 years
DCR
Proportion of subjects with CR, PR, or stable disease (SD) at BOR
Time frame: 2 years
OS
The time from first dose to death from any cause
Time frame: 2 years
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