Combining Furmonertinib With Local Therapy for Inoperable Early-stage Lung Cancer: A Phase II Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: furmonertinib, ablation, stereotactic body radiotherapy.
- Who it may be relevant to
- Registry conditions: Non-small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Furmonertinib Combined With Local Therapy in Inoperable or Surgery-Refusing Early-Stage Non-Small Cell Lung Cancer:A Single-arm, Phase II Study
Overview
The goal of this Single-arm, Phase II clinical trial is to learn whether ablation or stereotactic radiotherapy combined with furmonertinib can treat early-stage non-small cell lung cancer in patients who are inoperable or refuse surgery. The main purposes of this study is to answer: Can ablation or stereotactic radiotherapy combined with furmonertinib improve survival in patients with early-stage NSCLC who are inoperable or refuse surgery? Can ablation or stereotactic radiotherapy combined with furmonertinib reduce recurrence in patients with early-stage NSCLC who are inoperable or refuse surgery?
Interventions
- Drug furmonertinib
furmonertinib 80 mg once daily (QD), administered orally for 3 consecutive years - Procedure ablation
1. Immobilization and image guidance: Supine or prone position; vacuum cushion or mask to limit motion. CT guidance for entry point, angle, and depth; ultrasound for selected peripheral lesions. 2. Ablation target planning: Ablation zone should cover GTV with ≥5-10 mm margin. For tumors near critical structures, pursue adequate margin when safe; consider heat sink or thermal isolation. 3. Ablation procedure: Choose MWA, RFA, or cryoablation based on tumor size, location, anatomy, and resources. - Radiation stereotactic body radiotherapy
1. Immobilization: Use a thermoplastic mask or vacuum cushion for immobilization based on the treatment site. 2. CT simulation: After immobilization and stabilization of breathing, laser alignment is performed, followed by 4D-CT simulation (preferred) or conventional CT simulation. 3. Radiotherapy target delineation and dose: GTV includes the primary lung tumor and metastatic lymph nodes after chemotherapy. A 5-mm margin is added to form the PTV. 4. Radiotherapy plan: For peripheral lesions: 48
Primary outcome measures
- 2-year EFS rate [Time frame: Within two years after the treatment]
Secondary outcome measures (4)
- 3-year EFS rate [Time frame: Within three years after the treatment]
- overall survival [Time frame: through study completion, an average of 5 year]
- Local control rate (LCR) [Time frame: through study completion, an average of 1 year]
- Time to distant metastasis [Time frame: through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- Voluntarily participate in the clinical study
- Aged ≥ 18 years at the time of signing the informed consent form
- Histologically or cytologically confirmed early-stage T1-3 N0 NSCLC, or patients with multiple primary lesions or solitary pulmonary parenchymal recurrence
- Confirmed presence of EGFR-sensitive mutations by genetic testing, including but not limited to Exon 19 deletion, L858R, G719X, L861Q, S768I, and their compound mutations
- ECOG performance status score of 0-2
- Deemed medically inoperable or refuse surgery after multidisciplinary evaluation
- Pulmonary lesions suitable for ablation or radiotherapy (either modality)
- Adequate major organ function
Exclusion criteria
- Known severe allergic reaction (NCI-CTCAE v5.0 grade ≥ 3) to any monoclonal antibody or any excipient of the study drug
- Known contraindications to ablation or radiotherapy
- Failure to meet the minimum requirements for target coverage and dose constraints to organs at risk in the SABR treatment plan
- Active infection requiring systemic anti-infective therapy within 14 days prior to the first dose
- Patients with hepatitis B (hepatitis B surface antigen \[HBsAg\] positive and detectable HBV-DNA indicating viral replication); hepatitis C (hepatitis C virus \[HCV\] antibody positive and detectable HCV-RNA indicating viral replication)
- Receipt of curative-intent radiotherapy within 3 months prior to the first dose
- Major surgery within 28 days prior to the first dose (major surgery in this study is defined as any procedure requiring at least 3 weeks of recovery before the study treatment can be administered)
- Concurrent participation in another clinical study, or receipt of intervention in any other clinical trial (including drugs and devices) within 3 months or 5 half-lives prior to screening, whichever is longer
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Pulmonary Hospital — Shanghai
Identifiers
NCT: NCT07517640 · 2026LY0109