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

Huazhong University of Science and Technology

Status and phase: Enrolling; Phase 2

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Carboplatin; Drug: Carrelizumab; Procedure: Surgery; Drug: Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel(Squamous NSCLC)

Study type: Interventional

Funder types: Other

Identifiers

NCT04943029

NEOSUN

Details and patient eligibility

About

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.

Full description

Concurrent chemoradiotherapy is the recommended therapeutic approach for patients with unresectable stage III non-small cell lung cancer(NSCLC), although surgery offers the chance of cure. With combined radiation and chemotherapy, the prognosis of unresectable stage III NSCLC remains poor. Immunotherapy combined with chemotherapy has been shown to be efficacious as treatment for advanced non-squamous non-small-cell lung cancer (NSCLC) without targetable genetic aberrations. Camrelizumab, a humanised monoclonal antibody against PD-1, has shown its efficacy in the treatment of advanced NSCLC. This study is to studying neoadjuvant camrelizumab plus double platinum based chemotherapy followed by surgery to see how well it works in treating patients with unresectable stage III NSCLC.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

PD-1+Chemo+surgery+PD-1

Experimental group

Description:

Participants will receive neoadjuvant Carrelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection and adjuvant Carrelizumab for 16 cycles.

Treatment:

Drug: Carrelizumab

Drug: Carboplatin

Procedure: Surgery

Drug: Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel(Squamous NSCLC)