NCT05782426

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

Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection, Platinum (Cisplatin/Carboplatin) Combined With Sindilizumab Injection in the First-line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Jiangsu Cancer Institute & Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with histologically or cytologically confirmed metastatic or recurrent stage ⅢB/Ⅳ 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 (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. Patients receiving sindilizumab who has first radiologic evidence of PD according to RECIST 1.1 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.

Conditions

• Non-squamous NSCLC

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-15
• Primary completion: 2024-01-31
• Completion: 2026-01-31
• First posted: 2023-03-23
• Last updated: 2023-03-23

Locations

2 sites across 1 country: China