This study is a single-arm, phase II clinical trial evaluating the safety and efficacy of IBI363 combined with chemotherapy as a neoadjuvant treatment of non-small cell lung cancer.
NSCLC patients receive IBI363 combined with platinum-based chemotherapy. If multidisciplinary team (MDT) assessment determines the patient is surgically eligible, surgery is performed followed by 1 year of standard adjuvant therapy. If, after 4 treatment cycles, MDT assessment determines the tumor remains unresectable, concurrent chemoradiotherapy followed by immune checkpoint inhibitor consolidation therapy is administered. This study aims to evaluate the efficacy of IBI363 combined with chemotherapy for neoadjuvant treatment of initially unresectable NSCLC based on R0 resection rate, major pathological response (MPR) rate, and pathological complete response (pCR) rate.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
1. Neoadjuvant treatment: IBI363 combined with platinum-based chemotherapy. 2. Multidisciplinary team(MDT) assessment: Participants deemed operable by the MDT will undergo surgery, and then can continue to receive standard adjuvant therapy for one year. If the NSCLC remained unresectable, concurrent chemoradiotherapy was administered followed by immune checkpoint inhibitor consolidation therapy to maintain.
Shanghai Pulmonary Hospital
Shanghai, China
RECRUITINGR0 Rate
The proportion of subjects who underwent lung cancer resection and achieved complete resection (R0) among those receiving IBI363 combined chemotherapy conversion therapy.
Time frame: about 4 months after enrollment
MPR Rate
Defined as the proportion of patients who have achieved major pathologic response (with ≤10% viable tumor cells) in all patients after surgery.
Time frame: about 5 months after enrollment
pCR Rate
Defined as the proportion of all patients who completed treatment and had no invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after surgery
Time frame: about 5 months after enrollment
Tumor Downstaging Rate
Defined as the proportion of patients whose imaging stage is downgraded through conversion therapy.
Time frame: up to 4 months
Overall Response Rate (ORR)
The proportion of patients who have had a complete response (CR) or partial response (PR) (according to RECIST1.1) after the neoadjuvant therapy.
Time frame: 12 weeks
2-Year EFS Rate
The 2-year EFS rate is estimated using Kaplan-Meier survival analysis. The time from randomization to first occurrence of progression, disease recurrence (including local and distant recurrence), or death from any cause is assessed according to RECIST v1.1.
Time frame: up to 2 years
2-Year OS Rate
The 2-year OS rate is estimated based on the Kaplan-Meier survival analysis. OS is defined as the time from enrollment to death due to any cause.
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Time frame: up to 2 years
Incidence of Treatment-related Adverse Events
Number of participants with treatment-related adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v6.0.
Time frame: From the subject's written consent to participate in the study through 30 days after the final administration of the drug