A Phase III Trial of Neoadjuvant Sintilimab and Chemotherapy for NSCLC Harboring No Driver Mutations

Launched by TONGJI UNIVERSITY · Dec 14, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with resectable stage IIIA non-small cell lung cancer (NSCLC) that does not have certain genetic mutations (specifically, EGFR and ALK mutations). The trial is exploring the use of a medication called Sintilimab, which helps the immune system fight cancer, combined with chemotherapy before surgery. The goal is to see how effective this combination is in shrinking tumors and improving patients' chances of recovery.

To be eligible for this trial, participants must be between 18 and 75 years old, have been diagnosed with stage IIIA NSCLC without EGFR or ALK mutations, and have not received previous treatment for their cancer. Patients can expect to receive the experimental treatment, regular monitoring, and support throughout the process. This trial is currently recruiting participants, and it’s important for potential volunteers to discuss their specific health conditions with their doctors to determine if they meet the eligibility criteria.

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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.