Non Small Cell Lung Cancer
Conditions
Keywords
Unresectable, Stage Ⅲ NSCLC, Neoadjuvant, chemoimmunotherapy, camerlizumab, PD-1, sugery
Brief summary
The purpose of this study is to evaluate the safety and efficacy of Camrelizumab in combination with platinum doublet neoadjuvant chemotherapy before surgery \[neoadjuvant phase\], followed by Camrelizumab alone after surgery \[adjuvant phase\] in participants with unresectable stage III non-small cell lung cancer.
Detailed description
Concurrent chemoradiotherapy is the recommended therapeutic approach for patients with unresectable stage III non-small cell lung cancer(NSCLC), although surgery offers the chance of cure. With combined radiation and chemotherapy, the prognosis of unresectable stage III NSCLC remains poor. Immunotherapy combined with chemotherapy has been shown to be efficacious as treatment for advanced non-squamous non-small-cell lung cancer (NSCLC) without targetable genetic aberrations. Camrelizumab, a humanised monoclonal antibody against PD-1, has shown its efficacy in the treatment of advanced NSCLC. This study is to studying neoadjuvant camrelizumab plus double platinum based chemotherapy followed by surgery to see how well it works in treating patients with unresectable stage III NSCLC.
Interventions
DRUGCarrelizumab
Camrelizumab: 200mg, IV, day 1 of each 21-day cycle, neoadjuvant therapy : 3 cycles; Adjuvant therapy: 16cycles.
DRUGPemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel(Squamous NSCLC)
Nab-paclitaxel: 260mg/m\^2, IV, day 1 of each 21-day cycle, 3 cycles; Pemetrexed: 500 mg/m\^2, IV, day 1 of each 21-day cycle, 3 cycles.
DRUGCarboplatin
Carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 i.v. on day 1 of each 21-day cycle for 3 cycles.
PROCEDURESurgery
Surgery must be done within the 4th-6th week from day 1 cycle 3 of neoadjuvant treatment (4-6 weeks after day 1 of cycle 3)
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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. * Age 18-70 when signing the consent form, both male and female; * The ECOG score is 0 or 1; * Unresectable stage III non-small cell lung cancer confirmed by histopathology or cytology（III A-bulky N2, III B，IIIC）; * Adequate hematological function, liver function and renal function; * Female participants should not be pregnant or breast-feeding.
Exclusion criteria
* EGFR mutation or ALK mutation was positive; * Previously received systemic anti-tumor therapy for non-small cell lung cancer; * Subjects who have received chest radiotherapy in the past; * Known human immunodeficiency virus (HIV) infection; * Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease); * Pregnancy or breast-feeding women; * Ingredients mixed with small cell lung cancer patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major pathological response (MPR) rate | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resectability rate | 1 year | Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy. |
| Percentage of incidence of adverse Events | approximately 16.5 months overall | The incidences and types of adverse events that occur during neoadjuvant therapy and perioperative period (within postoperative 30 days and 90 days) will be evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
| PFS | 2 year | Progression free survival |
| OS | 2 year | Overall survival |
Countries
China
Contacts
Primary ContactYongde Liao, PhD
Backup ContactMingliang Wang, MD
Outcome results
None listed