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.
The patient shall sign the informed consent.
Age ≥ 18 years.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Histologically or cytologically confirmed Stage III (per AJCC 9th) squamous or non-squamous non-small-cell lung cancer (NSCLC) deemed unresectable by the investigator.
Non-squamous and squamous NSCLC with EGFR active mutation positive, ALK rearrangement, or any other driver mutation with an approved targeted therapy.
History of other malignant tumors within five years or concurrently present, except adequately treated cervical carcinoma in situ, basal- or squamous-cell skin carcinoma, localized prostate cancer after radical prostatectomy, ductal carcinoma in situ after radical prostatectomy, or other tumor deemed cured by the investigator.
Histologically confirmed the presence of small cell lung cancer component.
Participants who have received any systemic anti-cancer treatment.
Single group
IBI363 + Chemotherapy
Drug1. 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.
R0 Rate
The proportion of subjects who underwent lung cancer resection and achieved complete resection (R0) among those receiving IBI363 combined chemotherapy conversion therapy.
MPR Rate
Defined as the proportion of patients who have achieved major pathologic response (with ≤10% viable tumor cells) in all patients after surgery.
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
Tumor Downstaging Rate
Defined as the proportion of patients whose imaging stage is downgraded through conversion therapy.
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.
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