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

Sponsor: Fujian Cancer Hospital
Study ID: NCT06260553
Phase: PHASE2
Status: Unknown

Conditions

EGFR/ ALK-negative Advanced NSCLC

Eligibility Criteria

Sex: ALL
Age: N/A - N/A
Healthy Volunteers: Not accepted

Interventions

tislelizumab and metronomic oral vinorelbine — DRUG
tislelizumab 200mg intravenous drip once every three weeks; Oral Vinorelbine 40mg three times a week for three weeks and Q28d for one course.

Study Details

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

Key Dates

Start date: Feb 7, 2024
Status verified: Feb 2024
Primary completion: Feb 7, 2025
Completion: Aug 7, 2025

Study Design

Enrollment: 40 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: tislelizumab plus metronomic oral vinorelbine

Primary Outcome Measure

PFS [ Time Frame: 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 ]