Clinical trial NCT05157776: A Phase III Trial of Neoadjuvant Sintilimab and Chemotherapy for NSCLC Harboring No Driver Mutations
Official title: Neoadjuvant Sintilimab and Platinum-based Chemotherapy for Resectable Locally Advanced NSCLC Harboring no Driver Mutations: A Prospective, Randomized, Multicenter Phase III Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: NSCLC, Stage IIIA
EGF-R Negative Non-Small Cell Lung Cancer
ALK Negative NSCLC
Keywords: Neoadjuvant
PD-1
NSCLC
Phase III
Platinum-based
Locally Advanced
Lead sponsor: Tongji University
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pathologically complete response (pCR) rate
timeFrame: in three weeks after the surgical resection
Secondary outcomes:
measure: Major pathological response (MPR) rate
timeFrame: in three weeks after the surgical resection
measure: Disease-free survival (DFS)
timeFrame: one, two, three and five years since the initial treatment (each treatment is 2 days)
measure: Minimal residual disease(MRD)
timeFrame: in one week before each cycle and in the forth week after the surgical resection (each cycle is 21 days)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
Study officials:
affiliation: Shanghai General Hospital; Shanghai Pulmonary Hospital
name: Jiang Fan, MD
role: PRINCIPAL_INVESTIGATOR
References: