Clinical trial NCT04943029: Neoadjuvant Immunotherapy and Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC
Official title: Induction Therapy With Chemoimmunotherapy Followed by Surgery for Unresectable Stage III Non-small Cell Lung Cancer: a Single-center, Single-arm, Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: Unresectable
Stage Ⅲ NSCLC
Neoadjuvant
chemoimmunotherapy
camerlizumab
PD-1
sugery
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Major pathological response (MPR) rate
timeFrame: 1 year
Secondary outcomes:
measure: Resectability rate
timeFrame: 1 year
measure: Percentage of incidence of adverse Events
timeFrame: approximately 16.5 months overall
measure: PFS
timeFrame: 2 year
measure: OS
timeFrame: 2 year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Union Hospital
Study officials:
affiliation: Wuhan Union Hospital, China
name: Yongde Liao, PhD
role: PRINCIPAL_INVESTIGATOR
References: