An interventional study of Bevacizumab combined with iruplinalkib as neoadjuvant therapy in ALK-positive NSCLC: in ALK, NSCLC and Neoadjuvant Therapy, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Not applicable, Interventional, and Treatment
This is a single-center, single-arm, prospective phase II trial evaluating iruplinalkib plus bevacizumab as neoadjuvant therapy in ALK-positive NSCLC. Eligible patients receive 4 cycles (Q3W) of iruplinalkib (60 mg lead-in for 7 days, then 180 mg daily, PO) plus bevacizumab (15 mg/kg, IV, D1). Surgery is performed 4 weeks later, followed by adjuvant iruplinalkib monotherapy for up to 2 years. Primary endpoint is major pathological response (MPR) rate; secondary endpoints include safety, R0 resection rate, and survival outcomes.
Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 157 studies on the registry; 94 are open to participants now.
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Age 18-80 years, both sexes.
Histologically or cytologically confirmed NSCLC.
Stage II-III NSCLC per investigator, and ALK-positive.
At least one measurable lesion per RECIST 1.1.
ECOG performance status 0-1.
Adequate organ and bone marrow function (within 7 days before first dose, no transfusion or growth factor support within 14 days):
Hb ≥90 g/L, ANC ≥1.5×10⁹/L, PLT ≥90×10⁹/L;
Cr ≤1.5×ULN; TBIL ≤1.5×ULN; ALT/AST ≤3.0×ULN (or ≤5.0×ULN if liver metastases), ALB ≥25 g/L;
INR ≤1.5×ULN, PT/APTT ≤1.5×ULN (or within therapeutic range for anticoagulated patients).
FEV₁ >60% predicted.
Women of childbearing potential: negative pregnancy test (serum/urine) within 7 days before enrollment and use of reliable contraception from screening to 3 months after last study drug. Men: adequate contraception or surgically sterile.
Expected survival ≥12 weeks.
Exclusion Criteria:
Prior targeted therapy (TKI or mAb), immunotherapy, or investigational drugs for NSCLC.
Mixed small-cell and non-small-cell histology.
Other malignancy within 5 years, except cured basal cell carcinoma, early GI cancer (endoscopically resected), cervical CIS, DCIS, papillary thyroid cancer, or other cured cancers deemed not to affect survival.
Unstable systemic disease: active infection, uncontrolled hypertension (>160/110 mmHg), unstable angina or angina within 3 months, CHF (NYHA ≥II), MI within 6 months, clinically significant arrhythmia requiring treatment, or QTc >480 ms (average of 3 consecutive measurements if prolonged).
History of extensive diffuse interstitial lung disease or grade 3/4 pulmonary fibrosis/ILD (excluding localized radiation pneumonitis).
Congenital or acquired immunodeficiency (e.g., HIV).
Major surgery within 4 weeks before study treatment, or planned major surgery during study.
Inability to swallow tablets or malabsorption affecting GI absorption.
Known risk of GI perforation or intestinal obstruction.
Pregnant or lactating women.
Any other condition (e.g., alcohol/drug abuse, serious concomitant disease including psychiatric, severe laboratory abnormalities, or social factors) that, in the investigator's opinion, could interfere with study conduct or patient safety.
History of abdominal fistula, GI perforation, intra-abdominal abscess, or thrombotic disease within 6 months, or judged intolerant to bevacizumab.
Evidence of hereditary bleeding diathesis or coagulopathy.
Minor surgery (e.g., catheter placement) within 48 hours before first bevacizumab infusion.
Imaging evidence of tumor invasion of major vessels (e.g., pulmonary artery or SVC) with bleeding risk per investigator.
Other factors making the patient unsuitable for the study per investigator.
The neoadjuvant treatment phase consists of 4 cycles (Q3W) of bevacizumab (15 mg/kg, intravenous infusion on day 1 of each cycle) combined with iruplinalkib (oral, with a 7-day lead-in of 60 mg once daily, then escalated to 180 mg once daily if tolerated). Surgery is performed 4 weeks after completion of neoadjuvant therapy, and adjuvant maintenance therapy with iruplinalkib monotherapy (180 mg once daily, for up to 2 years) is initiated within 4-8 weeks post-surgery. Discontinuation criteria include disease progression, unacceptable toxicity, or loss of clinical benefit.
Drug: Bevacizumab combined with iruplinalkib as neoadjuvant therapy in ALK-positive NSCLC:
Eligible patients receive 4 cycles (Q3W) of bevacizumab (15 mg/kg IV on D1) plus iruplinalkib (60 mg oral lead-in for 7 days, then 180 mg daily). Surgery is performed 4 weeks after neoadjuvant therapy, followed by adjuvant iruplinalkib monotherapy for up to 2 years (starting within 4-8 weeks post-surgery), continued until progression, unacceptable toxicity, or loss of benefit.
Pathological complete response (pCR) rate
The proportion of subjects undergoing lung cancer resection who have no residual viable tumor cells in both the postoperative tumor bed and lymph nodes.
Time frame: up to 30 months
Progression-free survival (PFS)
Time from enrollment to tumor progression or death from any cause, whichever occurs first.
Time frame: up to 40 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Shanghai Pulmonary Hospital, Shanghai, China →