Combining Furmonertinib With Local Therapy for Inoperable Early-stage Lung Cancer: A Phase II Trial

Furmonertinib Combined With Local Therapy in Inoperable or Surgery-Refusing Early-Stage Non-Small Cell Lung Cancer:A Single-arm, Phase II Study

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: furmonertinib; Procedure: ablation; Radiation: stereotactic body radiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chang Chen; Phone Number: +86 21 65115006; Email: shsfkyy@126.com

Study Locations

• China
  • Shanghai, China, 200433
    • Shanghai Pulmonary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Local therapy; Subjects will receive ablation or stereotactic body radiotherapy, followed by sequential treatment with furmonertinib for 3 years. Dosing regimen: furmonertinib 80 mg once daily (QD), administered orally for 3 consecutive years.

Drug: furmonertinib; furmonertinib 80 mg once daily (QD), administered orally for 3 consecutive years; Procedure: ablation; 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.; 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.; Ablation procedure: Choose MWA, RFA, or cryoablation based on tumor size, location, anatomy, and resources.; Intraprocedural monitoring and endpoint assessment: CT during/after ablation to confirm ground-glass opacity covers tumor with planned margin. Ablation zone ≥5 mm beyond tumor = technical success. If inadequate, reposition and supplement.; Post-procedure management and follow-up: Monitor vital signs; manage complications as needed.; Radiation: stereotactic body radiotherapy; Immobilization: Use a thermoplastic mask or vacuum cushion for immobilization based on the treatment site.; CT simulation: After immobilization and stabilization of breathing, laser alignment is performed, followed by 4D-CT simulation (preferred) or conventional CT simulation.; 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.; Radiotherapy plan: For peripheral lesions: 48 Gy in 4 fractions or 50 Gy in 5 fractions; for central lesions: 60 Gy in 8 fractions or 60 Gy in 10 fractions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-year EFS rate	defined as the proportion of patients who experience no event (including disease progression, recurrence, distant metastasis, discontinuation of treatment for any reason, or death) within 24 months from the start of treatment, relative to the total enrolled population.	Within two years after the treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year EFS rate	defined as the proportion of patients who experience no event (including disease progression, recurrence, distant metastasis, or death) within 36 months from the start of treatment, relative to the total enrolled population.	Within three years after the treatment
overall survival	defined as the time from the start of treatment to death from any cause	through study completion, an average of 5 year
Local control rate (LCR)	defined as the proportion of patients who show no radiographic enlargement or recurrence of the primary tumor during follow-up	through study completion, an average of 1 year
Time to distant metastasis	defined as the time from the start of treatment to the first occurrence of distant metastasis (e.g., to bone, brain, liver, or distant lymph nodes)	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
• Investigators: Study Chair: Xuefei Hu, Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Radiosurgery; aflutinib
• Other Study ID Numbers: 2026LY0109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No