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

NCT07517640 | Not Yet Recruiting Phase 2

• 1 other identifier: 2026LY0109
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 3-year EFS rate

  Within three years after the treatment

• overall survival

  through study completion, an average of 5 year

• Local control rate (LCR)

  through study completion, an average of 1 year

• Time to distant metastasis

  through study completion, an average of 1 year

Study Arms (1)

Local therapy

EXPERIMENTAL

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; Procedure: ablation; Radiation: stereotactic body radiotherapy

Interventions

furmonertinib DRUG

furmonertinib 80 mg once daily (QD), administered orally for 3 consecutive years

Local therapy

ablation PROCEDURE

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. 4. 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. 5. Post-procedure management and follow-up: Monitor vital signs; manage complications as needed.

Local therapy

stereotactic body radiotherapy RADIATION

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 Gy in 4 fractions or 50 Gy in 5 fractions; for central lesions: 60 Gy in 8 fractions or 60 Gy in 10 fractions.

Local therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, 200433, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

aflutinib; Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Xuefei Hu

  Shanghai Pulmonary Hospital, Shanghai, China

  STUDY CHAIR

Central Study Contacts

Chang Chen

CONTACT

+86 21 65115006; shsfkyy@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 8, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)