Neoadjuvant Immunotherapy and Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC

• Status: Recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuhan Union Hospital, China
• Treatments: Carboplatin; Paclitaxel; Pemetrexed

Criteria

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.