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

Phase 2

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: Carrelizumab; Drug: Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel(Squamous NSCLC); Drug: Carboplatin; Procedure: Surgery

• Registration Number: NCT04943029
• Lead Sponsor: Wuhan Union Hospital, China

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-18
• Study First Submitted QC: 2021-06-27
• Study First Posted: 2021-06-29
• Study Start: 2021-08-20
• Last Update Submitted: 2021-08-27
• Last Update Posted: 2021-09-02
• Primary Completion: 2022-05-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PD-1+Chemo+surgery+PD-1	Surgery	Participants will receive neoadjuvant Carrelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection and adjuvant Carrelizumab for 16 cycles.
PD-1+Chemo+surgery+PD-1	Carrelizumab	Participants will receive neoadjuvant Carrelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection and adjuvant Carrelizumab for 16 cycles.
PD-1+Chemo+surgery+PD-1	Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel(Squamous NSCLC)	Participants will receive neoadjuvant Carrelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection and adjuvant Carrelizumab for 16 cycles.
PD-1+Chemo+surgery+PD-1	Carboplatin	Participants will receive neoadjuvant Carrelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection and adjuvant Carrelizumab for 16 cycles.

Primary Outcome Measures

Name	Time	Method
Major pathological response (MPR) rate	1 year	MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.

Secondary Outcome Measures

Name	Time	Method
Resectability rate	1 year	Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.
Percentage of incidence of adverse Events	approximately 16.5 months overall	The incidences and types of adverse events that occur during neoadjuvant therapy and perioperative period (within postoperative 30 days and 90 days) will be evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
PFS	2 year	Progression free survival
OS	2 year	Overall survival

Trial Locations

Locations (1)

Wuhan Union Hospital; 🇨🇳 Wuhan, China