Neoadjuvant treatment for stage IIIA non-small cell lung cancer

Neoadjuvant Sintilimab and Platinum-based Chemotherapy for Resectable Locally Advanced NSCLC Harboring no Driver Mutations: A Prospective, Randomized, Multicenter Phase III Trial

This study is testing if a new combination of a cancer drug and chemotherapy can help people with stage IIIA non-small cell lung cancer before surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tongji University (Academic / other)
• Drugs / interventions: chemotherapy, Sintilimab
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05157776 on ClinicalTrials.gov

What this trial studies

This phase III clinical trial evaluates the safety and efficacy of combining the PD-1 antibody Sintilimab with platinum-based chemotherapy as a neoadjuvant treatment for patients with resectable stage IIIA non-small cell lung cancer (NSCLC) that lacks EGFR mutations and ALK rearrangements. Participants will receive two courses of treatment before being randomly assigned to either a control group, which undergoes surgical resection followed by postoperative treatment, or an experimental group that has surgery after the neoadjuvant treatment. The primary goal is to assess the pathologic complete response (pCR) rate, while secondary endpoints include major pathologic response (MPR), disease-free survival (DFS), and minimal residual disease (MRD).

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with resectable stage IIIA NSCLC who are negative for EGFR mutations and ALK rearrangements.

Not a fit: Patients with prior anti-tumor therapies or those with other malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve surgical outcomes and overall survival for patients with advanced NSCLC.

How similar studies have performed: Other studies have shown promising results with neoadjuvant PD-1 therapies in similar patient populations, indicating potential for success.

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.

Where this trial is running

Shanghai, Shanghai

• Shanghai General Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Jiang Fan, MD — Shanghai General Hospital; Shanghai Pulmonary Hospital
• Study coordinator: Jiang Fan, MD

Conditions NSCLC, Stage IIIA; EGF-R Negative Non-Small Cell Lung Cancer; ALK Negative NSCLC; Neoadjuvant; PD-1; NSCLC; Phase III; Platinum-based