Efficacy and safety of first-line oral vinorelbine plus firmonertinib in refractory EGFR-mutated non-small cell lung cancer: study protocol of a multicenter, non-randomized, two-cohort study

Description

Bo Zhang leads a 2026 study protocol for a multicenter trial of an all-oral drug combination in hard-to-treat lung cancer. The patients have non-small cell lung cancer with an EGFR mutation, a gene change that targeted drugs can attack. Standard combinations improve survival but need intravenous chemotherapy and cause more toxicity. The trial tests oral vinorelbine plus firmonertinib, a third-generation EGFR-blocking drug, as first treatment in two centers in China, without randomization.

Cohort one will enroll fifty-four patients whose cancer has spread widely. Cohort two will enroll seventy-seven patients whose tumors show a PD-L1 score of at least twenty-five percent. Treatment repeats every three weeks until progression or unacceptable toxicity. The primary endpoint is progression-free survival, with response rates, disease control, overall survival, and safety as secondary endpoints. Recruitment began on December 11, 2025.

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Source: https://europepmc.org/article/MED/PMC13260983