Back to resultsToripalimab Combined With Double Platinum Based Chemotherapy for Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer
Primary Purpose
Advanced Non Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Toripalimab combination with platinum-containing dual-drug chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Non Small Cell Lung Cancer focused on measuring Toripalimab NSCLC
Eligibility Criteria
Inclusion Criteria:
- Previously untreated, histologically confirmed potentially resectable stage IIIA or IIIB (AJCC staging eighth edition) NSCLC; potentially resectable refers to a discussion by the surgeon, including primary T3 or T4, mediastinum Lymph node metastasis (N2) is defined as: single-site or multi-station metastasis can be confirmed by imaging or pathology with a short diameter ≥ 2 cm, and it is expected that resection is difficult or pneumonectomy is required;
- Before the enrollment, submit the PD-L1 immunohistochemistry section and the corresponding pathology report for biomarker evaluation (the tumor tissue sample must be fresh or archived samples obtained within 3 months before enrollment; Fresh tissue must be a needle biopsy, excision or incision biopsy specimen);
Exclusion Criteria:
Patients received Toripalimab before Patients with contraindication of chemotherapy Pregnant or breast feeding women
Sites / Locations
- Hunan Provincal Tumor Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Toripalimab Combined With Platinum-containing Dual-agent
Arm Description
Toripalimab combined with platinum-containing dual-agent as a neoadjuvant Therapy for Non-small Cell Lung Cancer
Outcomes
Primary Outcome Measures
R0 surgical resection rate
No residual ratio under the microscope after surgical resection
Secondary Outcome Measures
ORR
To measure the patients's overall response rate
MPR
Neoadjuvant therapy-induced tumor regression in pathologically residual tumors <10%
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04144608
Brief Title
Toripalimab Combined With Double Platinum Based Chemotherapy for Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer
Official Title
A Phase II Study on Toripalimab Combined With Double Platinum Based Chemotherapy for as a Neoadjuvant Therapy for Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 16, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
July 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yongchang Zhang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of the study was to investigate the safety and efficacy of Toripalimab Combined With Double Platinum Based Chemotherapy for Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Non Small Cell Lung Cancer
Keywords
Toripalimab NSCLC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Toripalimab Combined With Platinum-containing Dual-agent
Arm Type
Experimental
Arm Description
Toripalimab combined with platinum-containing dual-agent as a neoadjuvant Therapy for Non-small Cell Lung Cancer
Intervention Type
Drug
Intervention Name(s)
Toripalimab combination with platinum-containing dual-drug chemotherapy
Intervention Description
Nab-paclitaxel/pem +cisplatin +PD-1(Nab-paclitaxel260mg/m2 D1 Cisplatin 75mg/m2 D1 or carboplatin,determined by the investigator AUC)PD-1 200mg D1
Primary Outcome Measure Information:
Title
R0 surgical resection rate
Description
No residual ratio under the microscope after surgical resection
Time Frame
Approximately 1 years
Secondary Outcome Measure Information:
Title
ORR
Description
To measure the patients's overall response rate
Time Frame
Approximately 1 years
Title
MPR
Description
Neoadjuvant therapy-induced tumor regression in pathologically residual tumors <10%
Time Frame
Approximately 1 years
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:
Previously untreated, histologically confirmed potentially resectable stage IIIA or IIIB (AJCC staging eighth edition) NSCLC; potentially resectable refers to a discussion by the surgeon, including primary T3 or T4, mediastinum Lymph node metastasis (N2) is defined as: single-site or multi-station metastasis can be confirmed by imaging or pathology with a short diameter ≥ 2 cm, and it is expected that resection is difficult or pneumonectomy is required;
Before the enrollment, submit the PD-L1 immunohistochemistry section and the corresponding pathology report for biomarker evaluation (the tumor tissue sample must be fresh or archived samples obtained within 3 months before enrollment; Fresh tissue must be a needle biopsy, excision or incision biopsy specimen);
Exclusion Criteria:
Patients received Toripalimab before Patients with contraindication of chemotherapy Pregnant or breast feeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongchang Z MD, MD
Organizational Affiliation
Hunan Province Tumor Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunan Provincal Tumor Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
12. IPD Sharing Statement
Learn more about this trial
Toripalimab Combined With Double Platinum Based Chemotherapy for Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer
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