This study was a parallel, randomized, multicenter phase II clinical trial to evaluate the efficacy and safety of TY-9591 combined with platinum-based chemotherapy as first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR sensitive mutations.
Male or female ≥18 years old and <80 years old.
Patients with non-squamous non-small cell lung cancer (NSCLC) diagnosed by histology or cytology as locally advanced (clinical stage IIIB, IIIC, no chance of radical surgery or radical chemoradiotherapy) or metastatic (clinical stage IVA, IVB) (according to the AJCC TNM staging criteria for lung cancer, 8th edition).
Tissue or blood samples tested positive for EGFR sensitive mutations (including exon 19 deletion, exon 21 L858R mutation, alone or in combination with other EGFR mutations) by central laboratory or research center, other tertiary hospitals, or third-party laboratories.
He had received no previous systemic antitumor therapy for locally advanced or metastatic non-small-cell lung cancer. Patients who had received previous adjuvant and neoadjuvant therapy and definitive radiotherapy/chemoradiotherapy were allowed if the last treatment was more than 12 months after disease recurrence or metastasis.
Previous treatment with any EGFR-TKI was performed.
Previous systemic anti-tumor therapy for advanced/metastatic non-small cell lung cancer (including chemotherapy, targeted therapy, biological therapy, immunotherapy, etc.), neoadjuvant and adjuvant therapy, definitive radiotherapy/chemoradiotherapy were eligible according to the inclusion criteria
Anti-tumor therapy with traditional Chinese medicine with anti-tumor indications was received within 7 days before the first dose of the study drug.
Prior whole brain radiotherapy (WBRT); Received >30% bone marrow or extensive radiation within 28 days before the first dose of study drug; Local radiotherapy or palliative radiotherapy for bone metastases had been administered within 7 days before the first dose of study drug.
Parallel
TY-9591 80mg QD+pemetrexed+Cisplatin/Carboplatin
DrugTY-9591 80mg QD+pemetrexed 500mg/m²（D1，Q3w）+Carboplatin AUC5/ Cisplatin 75mg/m²（D1，Q3w\*4 cycles）
TY-9591 160mg QD+pemetrexed+Cisplatin/Carboplatin
DrugTY-9591 160mg QD+pemetrexed 500mg/m²（D1，Q3w）+Carboplatin AUC5/ Cisplatin 75mg/m²（D1，Q3w\*4 cycles）
ORR
Defined as the proportion of subjects with an optimal response of CR or PR observed throughout the study from the start of randomization until first disease progression
PFS
It was defined as the time from the start of randomization to the first occurrence of disease progression or death from any cause, whichever occurred first
DoR
It was defined as the time during study treatment from the first assessment of a tumor as CR or PR to the first assessment of PD or death from any cause, whichever occurred first
DCR
The optimal response observed throughout the study from randomization to first disease progression was the proportion of subjects with CR or PR or SD (duration ≥6 weeks)
OS
It was defined as the time from the start of randomization to death from any cause
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