This is a Phase 2, prospective, single-arm, open-Label, single-center study that to find out (1)The effectiveness and safety of toripalimab combined with platinum-doublet chemotherapy as a preoperative neoadjuvant therapy for locally advanced (stage IIB, IIIA, and resectable stage IIIB) NSCLC, (2)The best treatment time for this combination of neoadjuvant therapy before surgery, (3)The effectiveness and safety of combination of neoadjuvant therapy as salvage neoadjuvant therapy after failure of neoadjuvant chemo-only for locally advanced non-small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
cisplatin + paclitaxel/ albumin-bound paclitaxel/ gemcitabine/ Pemetroxel+ Toripalimab (cisplatin 75mg/m2 (D1), paclitaxel 175mg/m2 (D1), or albumin-bound paclitaxel 260mg/m2 (D1), or gemcitabine 1250mg/m2 (D1, D8), or Pemetroxel 500mg/m2 (D1)), Toripalimab 240mg D1, Q3W. If the patient is SD or PD, Toripalimab combined with platinum-containing dual-drug chemotherapy in the third cycle will continue, and a total of 4 cycles can be carried out at most, and the therapeutic effect will be evaluated after each cycle of treatment. If the patient is PR or CR at any time during the treatment (after treatment in the third or fourth cycle), the surgical treatment will be entered. If PR or CR is still not reached after treatment in the fourth cycle, the endpoint of the trial will be reached, theobservation of the patient will be finished, and the subsequent treatment will be decided by the clinician.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Major pathological response (MPR) rate
MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the pathological examination of resected specimens.
Time frame: At time of surgery
Complete pathological response (pCR) rate
pCR rate is defined as the percentage of participants having no tumor cells in the pathological examination of resected specimens.
Time frame: At time of surgery
R0 surgical resection rate
No residual ratio under the microscope after surgical resection
Time frame: At time of surgery
Objective response rate (ORR)
ORR is defined as the percentage of participants having a complete response or a partial response, measured by RECIST 1.1.
Time frame: Baseline (Prior to surgery)
Adverse Events (AEs)
Incidence of all grade AE which has been confirmed to be correlated with neoadjuvant treatment.
Time frame: Approximately 2 years after the last patient registered.
Event-free survival(EFS)
Event-free survival was defined as the time from the first treatment to any progression of disease precluding surgery, progression or recurrence of disease after surgery, progression of disease in the absence of surgery, or death from any cause
Time frame: Approximately 2 years after the last patient registered.
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