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

Non Small Cell Lung Cancer Clinical Trial

— NEOSUN  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04943029
• Other study ID #: NEOSUN
• Status: Recruiting
• Phase: Phase 2
• Start date: August 20, 2021
• Est. completion date: August 1, 2024

Study information

• Verified date: June 2021
• Source: Wuhan Union Hospital, China
• Contact: Yongde Liao, PhD
• Phone: +86 15972212919
• Email: liaotjxw[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 1, 2024
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Carrelizumab
Camrelizumab: 200mg, IV, day 1 of each 21-day cycle, neoadjuvant therapy : 3 cycles; Adjuvant therapy: 16cycles.
• Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel(Squamous NSCLC)
Nab-paclitaxel: 260mg/m^2, IV, day 1 of each 21-day cycle, 3 cycles; Pemetrexed: 500 mg/m^2, IV, day 1 of each 21-day cycle, 3 cycles.
• Carboplatin
Carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 i.v. on day 1 of each 21-day cycle for 3 cycles.

Procedure:
• Surgery
Surgery must be done within the 4th-6th week from day 1 cycle 3 of neoadjuvant treatment (4-6 weeks after day 1 of cycle 3)

Locations

Country	Name	City	State
China	Wuhan Union Hospital	Wuhan

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major pathological response (MPR) rate	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.	1 year
Secondary	Resectability rate	Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.	1 year
Secondary	Percentage of incidence of adverse Events	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.	approximately 16.5 months overall
Secondary	PFS	Progression free survival	2 year
Secondary	OS	Overall survival	2 year