search
Back to results

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

Primary Purpose

Non Small Cell Lung Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Carrelizumab
Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel(Squamous NSCLC)
Carboplatin
Surgery
Sponsored by
Wuhan Union Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Unresectable, Stage Ⅲ NSCLC, Neoadjuvant, chemoimmunotherapy, camerlizumab, PD-1, sugery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Wuhan Union HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PD-1+Chemo+surgery+PD-1

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Resectability rate
Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.
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.
PFS
Progression free survival
OS
Overall survival

Full Information

First Posted
June 18, 2021
Last Updated
August 27, 2021
Sponsor
Wuhan Union Hospital, China
search

1. Study Identification

Unique Protocol Identification Number
NCT04943029
Brief Title
Neoadjuvant Immunotherapy and Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuhan Union Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
Unresectable, Stage Ⅲ NSCLC, Neoadjuvant, chemoimmunotherapy, camerlizumab, PD-1, sugery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PD-1+Chemo+surgery+PD-1
Arm Type
Experimental
Arm Description
Participants will receive neoadjuvant Carrelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection and adjuvant Carrelizumab for 16 cycles.
Intervention Type
Drug
Intervention Name(s)
Carrelizumab
Other Intervention Name(s)
PD-1 antibody
Intervention Description
Camrelizumab: 200mg, IV, day 1 of each 21-day cycle, neoadjuvant therapy : 3 cycles; Adjuvant therapy: 16cycles.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel(Squamous NSCLC)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
chemotherapeutic drug
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
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)
Primary Outcome Measure Information:
Title
Major pathological response (MPR) rate
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Resectability rate
Description
Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.
Time Frame
1 year
Title
Percentage of incidence of adverse Events
Description
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.
Time Frame
approximately 16.5 months overall
Title
PFS
Description
Progression free survival
Time Frame
2 year
Title
OS
Description
Overall survival
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongde Liao, PhD
Phone
+86 15972212919
Email
liaotjxw@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mingliang Wang, MD
Phone
+86 15927066167
Email
wml6667@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongde Liao, PhD
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wuhan Union Hospital
City
Wuhan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingliang Wang, MD
Phone
+86 15927066167
Email
wml6667@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs