This is a single-arm clinical study planning to enroll 30 treatment-naive patients with resectable ALK-positive non-squamous non-small cell lung cancer (NSCLC). The study consists of two phases: a safety lead-in phase and an expansion phase.
Safety Lead-in Phase A total of 6 subjects will be enrolled and treated with the regimen: iruplaltinib 60 mg orally once daily on Days 1-7, followed by 180 mg orally once daily starting on Day 8, combined with pemetrexed 500 mg/m² intravenously every 3 weeks for one cycle (3 weeks).
Adopting the modified Toxicity Probability Interval-2 (mTPI-2) design with a target dose-limiting toxicity (DLT) rate of 30%, DLTs occurring within the 21-day observation period after the first dose among the 6 subjects will be evaluated. Unlike standard mTPI-2 design with decisions of "stay" or "escalate", if the decision in this safety lead-in phase is "stay" or "escalate", the lead-in phase will be completed and the study will proceed to the expansion phase. If the decision is "de-escalate" or "exclude this dose from the study", the study will be terminated.
Expansion Phase Eligible screened patients will receive iruplaltinib (60 mg po QD d1-7; then 180 mg po QD starting on Day 8) plus pemetrexed (500 mg/m² iv Q3W). Patients will receive 6 weeks of pre-operative treatment followed by curative resection, which is scheduled to be performed within 4 weeks after completion of neoadjuvant therapy. Patients with progressive disease (PD) will receive subsequent therapy such as alectinib or brigatinib at the investigator's discretion. Four weeks after curative surgery, patients will receive adjuvant iruplaltinib for up to 2 years.
Voluntarily participate in this study and provide written informed consent.
Aged between 18 and 75 years inclusive.
Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) via core needle biopsy; stage IIA-IIIB disease assessed by the investigator; confirmed ALK-positive status by genetic testing.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Prior receipt of any systemic anti-tumor therapy for NSCLC, including chemotherapy, biotherapy, immunotherapy or any investigational agent, or prior locoregional radiotherapy.
Pathological diagnosis of mixed small cell lung cancer, small cell lung cancer, or squamous non-small cell lung cancer.
History of malignancies other than NSCLC within 5 years prior to enrollment, except cured basal cell carcinoma of the skin, early gastrointestinal (GI) carcinoma resected endoscopically, cervical carcinoma in situ, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, or any cured malignancy deemed not to affect survival related to current NSCLC.
Participation in another clinical study or receiving other investigational products; or receipt of other investigational products within 4 weeks before the first dose of study drug. The interval from the last dose of other anti-tumor therapy to the first study drug is less than 2 weeks if the half-life ≤ 3 days, or less than 4 weeks if the half-life > 3 days.
Single group
iruplaltinib and pemetrexed
DrugTreatment with iruplaltinib (60 mg po QD on Days 1-7; followed by 180 mg po QD starting on Day 8) combined with pemetrexed (500 mg/m² iv Q3W). Patients receive 6 weeks of preoperative treatment followed by curative resection, which is scheduled to be performed within 4 weeks upon completion of neoadjuvant therapy. Patients with progressive disease (PD) will receive subsequent treatment such as alectinib or brigatinib at the investigator's discretion. Adjuvant iruplaltinib will be administered 4 weeks after curative surgery for up to 2 years.
Major Pathological Response Rate
Proportion of patients achieving major pathological response (≤10% viable tumor cells in resected specimen) after neoadjuvant therapy.
Pathological Complete Response Rate
Proportion of patients achieving pathological complete response (no viable tumor cells in primary lesion and resected lymph nodes) after neoadjuvant therapy.
Objective Response Rate
Proportion of patients with confirmed complete response (CR) or partial response (PR) assessed by RECIST v1.1 during neoadjuvant treatment
Disease Control Rate
Proportion of patients achieving confirmed CR, PR or stable disease (SD) assessed by RECIST v1.1 during neoadjuvant treatment.
R0 Resection Rate
Proportion of patients undergoing R0 curative resection
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