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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

NCT07781202 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-24

No results posted yet for this study

Summary

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

Conditions

  • HER2-mutated Advanced Non-small Cell Lung Cancer With Oligoprogression

Interventions

DRUG

Trastuzumab Rezetecan combined with radiotherapy

Trastuzumab 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.

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-30
Primary Completion
2029-08-30
Completion
2029-08-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07781202 on ClinicalTrials.gov