This is a phase II, non-randomized, open-label, multi-center study to evaluate the efficacy of neoadjuvant Sintilimab (PD-1 antibody) or combined with chemotherapy as first-line treatment in patients with stage III non-small cell lung cancer (NSCLC).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Neoadjuvant treatment stage: Sintilimab 200mg, q3w, i.v., 2-4 cycles, then receive chest CT evaluation. Surgery stage: the patients will receive radical surgery after the neoadjuvant treatment. Adjuvant treatment stage: according to the NCCN guidelines.
Neoadjuvant treatment stage: Sintilimab 200mg, q3w, i.v., 2-4 cycles; platinum-based chemotherapy (Non-squamus: Carboplatin AUC 5 + Pemetrexed 500mg/m2; Squamous: Carboplatin AUC 5 + Gemcitabine 1000mg/m2 or Paclitaxel 200mg/m2) q3w, i.v., 2-4 cycles, then receive chest CT evaluation. Surgery stage: the patients will receive radical surgery after the neoadjuvant treatment. Adjuvant treatment stage: according to the NCCN guidelines.
Shanghai Pulmonary Hospital
Shanghai, China
RECRUITINGMajor pathologic response (MPR)
MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery
Time frame: up to 5 months
Objective response rate (ORR)
It refers to the proportion of patients who have had a complete response or partial response (according to RECIST1.1) as confirmed by CT evaluation after 3 weeks in all patients who have completed the neoadjuvant therapy.Only patients with measurable lesions at baseline will be analyzed.
Time frame: up to 4 months
Disease-free survival (DFS)
It refers to the time from radical surgery to relapse or death of a participant due to disease progression. In the case of a patient who still survives at the time of analysis, the latest evaluation date will be used for interpolation (censoring).
Time frame: up to 60 months
Progression-free survival (PFS)
It refers to the time from the first administration of drug in this study to the disease progression or death (including any cause of death in the case of no progression) as recorded in CRF, regardless of whether the patient exits from the treatment or receives other anti-cancer treatment before progression.
Time frame: up to 60 months
Overall survival (OS)
It is defined as the time from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date.
Time frame: up to 60 months
Safety: frequency of severe adverse events
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The frequency of severe adverse events from the participants enrolling to 30 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.
Time frame: up to 6 months