ALK Negative NSCLC, EGF-R Negative Non-Small Cell Lung Cancer, NSCLC, Stage IIIA
Conditions
Keywords
Neoadjuvant, PD-1, NSCLC, Phase III, Platinum-based, Locally Advanced
Brief summary
This is a randomized, open-label study designed to evaluate the safety and efficacy of neoadjuvant PD-1 antibody plus chemotherapy followed by surgery in resectable stage IIIA non-small cell lung cancer. The primary endpoint: pCR rate The second endpoint: MPR, DFS, MRD
Detailed description
This study is a prospective, multicenter, phase III randomized controlled clinical study. Stage IIIA NSCLC patients with EGFR mutation negative and ALK rearrangement negative were enrolled, and after 2 courses of treatment with Sintilimab combined with Platinum-based Chemotherapy, they were randomly assigned 1:1 to the control group (surgical resection and postoperative treatment for 2 courses are recommended) or the experimental group (surgery after 2 courses of treatment). The primary endpoint is pCR rate. The second endpoints are MPR, DFS, and MRD.
Interventions
Sintilimab+(Squamous)ABX+DDP/CBP, or (non-Squamous)PEM+DDP/CBP
Sponsors
Tongji University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Resectable stage IIIA NSCLC, EGFR mutation-negative and ALK rearrangement negative (8th UICC TNM staging); 2. No prior anti-tumor therapy for NSCLC; 3. Age from 18 to 75 years old; 4. Adequate organ function: Hemoglobin ≥9.0g/L; White blood cell count 4.0\ 10×109/L; The absolute value of neutrophils (ANC) ≥ 1.5×109/L; Platelet count ≥100×109/L; Total bilirubin ≤ 1.5 times the upper limit of normal; ALT and AST≤2.5 times the upper limit of normal; The international normalized ratio of prothrombin time is ≤1.5 times the upper limit of normal value, and the partial thromboplastin time is within the range of normal value; Creatinine ≤ 1.5 times the upper limit of normal; 5. No chemotherapy, radiotherapy or hormone therapy for malignant tumors, no history of other malignant tumors, excluding patients who have received hormone therapy for prostate cancer and have had DFS for more than 5 years; 6. ECOG 0～1;
Exclusion criteria
1. Double primary or multiple primary NSCLC; 2. EGFR mutation or ALK mutation was positive 3. patients with psychosis; 4. Pre-existing or coexisting bleeding disorders; 5. Other uncontrollable and inoperable patients; 6. Patients whose previous operations have prevented this operation from being performed; 7. Female patients who are pregnant or breastfeeding; 8. For patients who are allergic to the drugs in the program.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologically complete response (pCR) rate | in three weeks after the surgical resection |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response (MPR) rate | in three weeks after the surgical resection |
| Disease-free survival (DFS) | one, two, three and five years since the initial treatment (each treatment is 2 days) |
| Minimal residual disease(MRD) | in one week before each cycle and in the forth week after the surgical resection (each cycle is 21 days) |
Countries
China
Contacts
Primary ContactJiang Fan, MD
Backup ContactDong Lin, MD
Outcome results
None listed