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Study of Polymeric Micellar Paclitaxel, Platinum Combined With Sindilizumab Injection for Advanced Non-squamous NSCLC

NCT05782426 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-03-23

No results posted yet for this study

Summary

This is a prospective, single-arm, single-center, phaseⅡtrial to evaluate the efficacy and safety of Paclitaxel Polymeric Micelles for Injection, platinum (cisplatin/carboplatin) in combination with sindilizumab injection as first-line chemotherapy in advanced or metastatic non-squamous NSCLC patients without EGFR mutation or ALK rearrangement.

Conditions

Interventions

DRUG

paclitaxel polymeric micelles for injection

Patients will be treated with paclitaxel polymeric micelles for injection, platinum (cisplatin/carboplatin) 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(≤230mg/m\^2) can be continued based on investor's evaluation and patient's 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.

Sponsors & Collaborators

  • Jiangsu Cancer Institute & Hospital

    lead OTHER

Principal Investigators

  • Jifeng Feng · Affiliated to Jiangsu Cancer Hospital & Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-15
Primary Completion
2024-01-31
Completion
2026-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05782426 on ClinicalTrials.gov