Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437977
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-26
Brief Title:
Neoadjuvant Therapy of SBRT Sequencial With Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC PatientsneoR-TORCH
Sponsor:
Shanghai Chest Hospital
Organization:
Shanghai Chest Hospital
Study Overview
Official Title:
Neoadjuvant Therapy of SBRT Sequencial With Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC Patients A Multicenter Openlabel Randomized Phase III Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
neoR-TORCH
Brief Summary:
This is a randomized controlled multi-center phase III clinical study to evaluate the efficacy and safety of SBRT sequencial with Toripalimab and chemotherapy versus Toripalimab and chemotherapy for subjects with resectable stage II-III NSCLC
Detailed Description:
Subjects who meet all the inclusion criteria but do not meet any exclusion criteria are randomized into two groups at a ratio of 11 according to the stratification factors as below
Disease stage II vs IIIA vs IIIB
PD-L1 status PD-L1 expression 1 vs PD-L1 1 or not evaluable
Pathological type non-squamous cell carcinoma vs squamous cell carcinoma Neoadjuvant therapy should be started within 1 week after randomization Stereotactic body radiation therapy SBRT will be given for primary lung tumor 24Gy3fractions sequential toripalimab IV 240 mg Q3W will be given combined with platinum-based doublet drug chemotherapy for three cycles in the preoperative neoadjuvant therapy period for trial group the controlled group receive toripalimab IV 240 mg Q3W combined with platinum-based doublet drug chemotherapy for three cycles in the preoperative neoadjuvant therapy period Every 3 weeks of treatment is regarded as one cycle in which combined therapy is given in the first day of every cycle
All the subjects will receive preoperative radiological and surgical evaluation 4-6 weeks after neoadjuvant therapy
After 3 cycles of preoperative neoadjuvant therapy all the subjects who still have surgical indications will receive radical excision based on the surgical operation criteria of the World Association for Lung Cancer Research within 4-6 weeks after 3 cycles of preoperative neoadjuvant therapy The pTNM will be staged in accordance with AJCC Cancer Staging Manual version 8 All the specimens taken during the operation will be evaluated by local pathologists for the surgical margin The tumor tissue samples collected from subjects during the study will be submitted to the authorized central laboratory for blinded evaluation of pathological response and translational research
All the subjects who have completed the radical operation will receive one cycle of postoperative adjuvant therapy ie Toripalimab IV 240 mgplacebo platinum-based doublet drug chemotherapy in 30 days after the operation Then it will proceed to consolidation treatment period three weeks after adjuvant therapy In the consolidation treatment period Toripalimab IV 240 mgplacebo is given in each cycle of every 3 weeks for a total of 13 cycles Adverse events AEs will be monitored throughout the study and the severity will be graded to the guidelines listed in National Cancer Institute NCI common terminology criteria for adverse events CTCAE version 50 or above The safety will be followed up in the subjects who have received study treatment and discontinued the drug prematurely All the subjects will be followed up for overall survival until death withdrawal of informed consent or end of study
Disease stage II vs IIIA vs IIIB
PD-L1 status PD-L1 expression 1 vs PD-L1 1 or not evaluable
Pathological type non-squamous cell carcinoma vs squamous cell carcinoma Neoadjuvant therapy should be started within 1 week after randomization Stereotactic body radiation therapy SBRT will be given for primary lung tumor 24Gy3fractions sequential toripalimab IV 240 mg Q3W will be given combined with platinum-based doublet drug chemotherapy for three cycles in the preoperative neoadjuvant therapy period for trial group the controlled group receive toripalimab IV 240 mg Q3W combined with platinum-based doublet drug chemotherapy for three cycles in the preoperative neoadjuvant therapy period Every 3 weeks of treatment is regarded as one cycle in which combined therapy is given in the first day of every cycle
All the subjects will receive preoperative radiological and surgical evaluation 4-6 weeks after neoadjuvant therapy
After 3 cycles of preoperative neoadjuvant therapy all the subjects who still have surgical indications will receive radical excision based on the surgical operation criteria of the World Association for Lung Cancer Research within 4-6 weeks after 3 cycles of preoperative neoadjuvant therapy The pTNM will be staged in accordance with AJCC Cancer Staging Manual version 8 All the specimens taken during the operation will be evaluated by local pathologists for the surgical margin The tumor tissue samples collected from subjects during the study will be submitted to the authorized central laboratory for blinded evaluation of pathological response and translational research
All the subjects who have completed the radical operation will receive one cycle of postoperative adjuvant therapy ie Toripalimab IV 240 mgplacebo platinum-based doublet drug chemotherapy in 30 days after the operation Then it will proceed to consolidation treatment period three weeks after adjuvant therapy In the consolidation treatment period Toripalimab IV 240 mgplacebo is given in each cycle of every 3 weeks for a total of 13 cycles Adverse events AEs will be monitored throughout the study and the severity will be graded to the guidelines listed in National Cancer Institute NCI common terminology criteria for adverse events CTCAE version 50 or above The safety will be followed up in the subjects who have received study treatment and discontinued the drug prematurely All the subjects will be followed up for overall survival until death withdrawal of informed consent or end of study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None