Viewing Study NCT05782426



Ignite Creation Date: 2024-05-06 @ 6:47 PM
Last Modification Date: 2024-10-26 @ 2:54 PM
Study NCT ID: NCT05782426
Status: NOT_YET_RECRUITING
Last Update Posted: 2023-03-23
First Post: 2023-02-27

Brief Title: Study of Polymeric Micellar Paclitaxel Platinum Combined With Sindilizumab Injection for Advanced Non-squamous NSCLC
Sponsor: Jiangsu Cancer Institute Hospital
Organization: Jiangsu Cancer Institute Hospital

Study Overview

Official Title: Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection Platinum CisplatinCarboplatin Combined With Sindilizumab Injection in the First-line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer
Status: NOT_YET_RECRUITING
Status Verified Date: 2023-03
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: None
Brief Summary: This is a prospective single-arm single-center phaseⅡtrial to evaluate the efficacy and safety of Paclitaxel Polymeric Micelles for Injection platinum cisplatincarboplatin in combination with sindilizumab injection as first-line chemotherapy in advanced or metastatic non-squamous NSCLC patients without EGFR mutation or ALK rearrangement
Detailed Description: Patients with histologically or cytologically confirmed metastatic or recurrent stage ⅢBⅣ non-squamous NSCLC inoperable or inappropriate for radical concurrent chemoradiotherapy and without previous systemic treatment will be screened after signing Informed Consent Patients will be treated with paclitaxel polymeric micelles for injection platinum cisplatincarboplatin in combination with sindilizumab for 4-6 cycles If patient assessment is of clinical benefit maintenance therapy with sindilizumab plus paclitaxel polymeric micelles for injection 230mgm2 can be continued based on investors evaluation and patients own choice until disease progression PD unacceptable toxicity withdrawal of consent initiation of additional antineoplastic therapy death or other protocol-specified conditions for discontinuation of treatment whichever comes first

Patients receiving sindilizumab who has first radiologic evidence of PD according to RECIST 11 can continue the treatment if their clinical status is stable without evidence of rapid radiologic progression and if they are deemed by the investigator to be continuing to benefit from the treatment Re-evaluation by imaging is required after a minimum interval of 4 weeks 7 days if PD is confirmed by the re-evaluation the study treatment should be stopped If PD is not confirmed the study treatment can be continued with assessments at the planned time points for imaging as specified in the protocol until PD is confirmed on imaging

The maximum treatment duration of sindilizumab injection and paclitaxel polymeric micelles for injection is 24 months

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