Toripalimab Combined With Double Platinum Based Chemotherapy for Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer

Advanced Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04144608
• Other study ID #: TOGATHER
• Status: Completed
• Phase: Phase 2
• Start date: January 16, 2019
• Est. completion date: July 30, 2023

Study information

• Verified date: August 2023
• Source: Hunan Province Tumor Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 30, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. 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;

2. 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Toripalimab combination with platinum-containing dual-drug chemotherapy
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

Locations

Country	Name	City	State
China	Hunan Provincal Tumor Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Yongchang Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R0 surgical resection rate	No residual ratio under the microscope after surgical resection	Approximately 1 years
Secondary	ORR	To measure the patients's overall response rate	Approximately 1 years
Secondary	MPR	Neoadjuvant therapy-induced tumor regression in pathologically residual tumors <10%	Approximately 1 years