NSCLC, Stage III
Conditions
Brief summary
The purpose of this conversion therapy study is to evaluate the safety and efficacy of neoadjuvant of Tislelizumab combined with platinum doublet for stage III unresectable locally advanced NSCLC.
Interventions
DRUGTislelizumab
Tislelizumab: 200mg, IV, day 1 of each 21-day cycle, Neoadjuvant therapy : 3 cycles
DRUGPemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC)
Pemetrexed: 500 mg/m\^2, IV, day 1 of each 21-day cycle, 3 cycles. Paclitaxel: 60-75mg/m\^2, IV, day 1 of each 21-day cycle, 3 cycles. Nab-paclitaxel: 260mg/m\^2, IV, day 1 of each 21-day cycle, 3 cycles.
DRUGCarboplatin
AUC 5 mg/mL/min by IV infusion Q3W, given on cycle day 2.
Sponsors
Beijing Tsinghua Chang Gung Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent provided. * Unresectable stage III non-small cell lung cancer confirmed by histopathology or cytology. * ECOG score is 0 or 1. * Adequate hematological function, liver function and renal function.
Exclusion criteria
* Previously received systemic anti-tumor therapy for non-small cell lung cancer. * history or current (non-infectious) pneumonia/interstitial pneumonia requiring steroid treatment. * History or active pulmonary tuberculosis. * Active infections that require systemic treatment. * History or suspected autoimmune disease or immune deficiency who, in the judgment of the investigator, cannot tolerate immunotherapy. * Untreated active Hepatitis B. * Has a known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive). * Grade 3 or above peripheral neuropathy. * Severe allergic history to pemetrexed, paclitaxel, albumin-bound paclitaxel, carboplatin or other preventive drugs. * Underlying severe or uncontrolled disease. * Malignant tumors other than NSCLC within 5 years. * Any medical condition requiring systemic treatment with corticosteroids (prednisone or equivalent at a dose of \>10mg/ day) or other immunosuppressive agents within 14 days prior to treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resectability rate | At time of surgery | Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major pathological response rate (MPR) | At time of surgery | MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy. |
| Pathology complete response rate(pCR) | At time of surgery | pCR rate is defined as the percentage of participants lacking of evidence of viable tumor cells in the pathological examination of resected specimens. |
| R0 Resection rate | At time of surgery | R0 Resection rate is defined as the percentage of patients who were able to undergo R0 Resection surgery after neoadjuvant therapy. |
| Perioperative G3-4 Adverse Events (AEs) | Up to 1 month post surgery | The number of participants experiencing an perioperative G3-4 AE will be assessed. |
Countries
China
Contacts
Primary ContactFan Yang, Dr.
Outcome results
None listed