Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

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.

paclitaxel polymeric micelles for injection

Meiqi Shi

Jifeng Feng

Bo Shen

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.

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.

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

Objective Response Rate (ORR) Based on RECIST 1.1 assessed by investigator review, the proportion (%) of patients with confirmed best overall response of complete response (CR) or partial response (PR)

Disease Control Rate (DCR) Based on RECIST 1.1 assessed by investigate review ,the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR), or stable disease (SD).

Duration of Response (DOR) was defined as the time from the first documentation of CR or PR to the date of first documentation of PD or death (whichever occurred first) in participants with confirmed CR or PR based on RECIST 1.1 assessed by investigator review.

Progression-free Survival (PFS) was defined as the time from the first study dose date to the date of first documentation of disease progression or death (whichever occurred first) based on RECIST 1.1 assessed by investigator review. PD was defined as at least a 20% increase in the sum of LD of target and non-target lesions as compared with the smallest sum of LD and the increase of LD was at least 5 mm (including new lesions).

Overall Survival (OS) was measured from the date of first dose of study drug until date of death from any cause. Participants who were lost to follow-up and the participants who were alive at the date of data cutoff was censored at the date the participant was last known alive, whichever came earlier.

Safety was measured by number and grade of adverse events Number of Participants With adverse events (AE), Treatment-releated Adverse Events (TRAEs) , Serious Adverse Events (SAEs) and immune-related adverse events (irAE) , events will be classified according to CTCAE V5.0

Spots Global Cancer Trial Database for sindilizumab injection