A Multicenter, Single-Arm, Prospective Phase II Clinical Study of Trastuzumab Rezetecan Combined with Radiotherapy in Patients with HER2-Mutated Oligoprogressive Advanced Non-Small Cell Lung Cancer
Aged ≥18 and ≤75 years, male or female.
Confirmed HER2 mutation (detected by PCR or NGS). Patients developed oligoprogression after achieving tumor response following prior systemic therapy for advanced NSCLC (CR/PR/SD lasting ≥6 months).
Meet the definition of oligoprogression: under continuous systemic therapy, only 1-5 extracranial lesions progress, the number of organs involved by progressive lesions ≤3.
All oligoprogressive lesions planned for radiotherapy are extracranial and amenable to safely delivered fractionated radiotherapy.
None
Single group
Trastuzumab Rezetecan combined with radiotherapy
DrugTrastuzumab Rezetecan administered intravenously at a dose of 4.8 mg/kg Q3W until disease progression or intolerable toxicity occurs. Radiotherapy: Radiotherapy targeting oligoprogressive lesions is recommended to be completed within Cycle 1 or prior to Cycle 2 of Trastuzumab Rezetecan treatment. Radiotherapy shall adopt organ- and risk-adapted fractionation regimens with curative radiotherapy dose as the principle; high biological effective dose (BED) regimens capable of achieving durable local control are preferred. Stereotactic body radiation therapy (SBRT) may be prioritized for peripheral pulmonary, adrenal, hepatic and other lesions. Risk-adapted multifraction regimens will be applied to lesions located in the central thorax, mediastinal lymph nodes, spine and regions adjacent to critical organs at risk. The specific radiation dose will be determined comprehensively based on lesion location, size, distance to organs at risk and previous radiotherapy history.
Safety (incidence of Grade ≥3 interstitial lung disease)
from the first dose administration to the end of safety follow-up after study discontinuation
Progression-free survival， PFS
PFS is defined as the time elapsed between the start of treatment and the first sign of disease progression or death from any cause.
Overall response rate, ORR
Defined as the proportion of patients whose tumor volume reduction meets the predefined threshold (CR/PR) and lasts for the minimum required duration according to recognized response evaluation criteria (e.g., RECIST Version 1.1 for solid tumors).
Disease control rate, DCR
Number of cases with completed/partial response and stable disease after treatment as a percentage of evaluable cases.
duration of response, DoR
Defined as the time interval from the first documented assessment of complete response (CR) or partial response (PR) to the first documented assessment of progressive disease (PD) or death due to any cause
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