Metronomic Oral Vinorelbine Combination With Tislelizumab in EGFR/ALK-negative Advanced NSCLC

Phase 2

• Conditions: EGFR/ ALK-negative Advanced NSCLC
• Interventions: Drug: tislelizumab and metronomic oral vinorelbine

• Registration Number: NCT06260553
• Lead Sponsor: Fujian Cancer Hospital

Brief Summary

To evaluate the efficacy of metronomic chemotherapy combination with tislelizumab in EGFR/ALK-negative advanced NSCLC patients intolerant to first-line standard chemotherapy.

Detailed Description

This study is a clinical intervention study. The patients who comfirm the criteria will be treated with tislelizumab plus metronomic oral vinorelbine. The patients will be followed up until the tumor progressed, and the efficacy (PFS, ORR, DCR) of tumor therapy were evaluated. Drug administration regimen: tislelizumab 200mg intravenous drip once every 3 week3; Oral Vinorelbine 40mg three times a week for three weeks and Q28d for one course.

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-02-07
• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-07
• Last Update Submitted: 2024-02-07
• Study First Posted: 2024-02-15
• Last Update Posted: 2024-02-15
• Primary Completion: 2025-02-07
• Study Completion: 2025-08-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Has a histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b-American Joint Committee on Cancer [AJCC] 8th edition) squamous NSCLC or non-squamous NSCLC without sensitising EGFR or ALK alterations.
• Has measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment.
• Has not received prior systemic treatment for metastatic NSCLC.
• Has a life expectancy of at least 3 months.
• Has fully understood this study and voluntarily signed a written informed consent form.
• Deemed unsuitable by the investigator for any platinum-doublet chemotherapy due to poor performance status (ECOG performance status of 2-3)；>= 75 years of age；substantial comorbidities; contraindication(s) for any platinum-doublet chemotherapy.

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Exclusion Criteria

• Histological or cytological confirmation of small cell lung cancer.
• Has a known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Has disorders of oral medication.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tislelizumab plus metronomic oral vinorelbine	tislelizumab and metronomic oral vinorelbine	-

Primary Outcome Measures

Name	Time	Method
PFS	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months	progression-free survival

Secondary Outcome Measures

Name	Time	Method
ORR	up to 12 months	Objective Response Rate
DCR	up to 12 months	Disease Control Rate
AE	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months	Number of Participants Who Experienced an Adverse Event

Trial Locations

Locations (1)

Fujian cancer hospital; 🇨🇳 Fuzhou, Fujian, China