Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07517640

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

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?

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Pulmonary Hospital

Shanghai, 200433, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Furmonertinib

Drug

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

Ablation

Procedure
  • 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.

stereotactic body radiotherapy

Radiation
  • 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.

Primary outcomes

  1. 2-year EFS rate

    Time frame: Within two years after the treatment

    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.

Secondary outcomes

  1. 3-year EFS rate

    Time frame: Within three years after the treatment

    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.

  2. overall survival

    Time frame: through study completion, an average of 5 year

    defined as the time from the start of treatment to death from any cause

  3. Local control rate (LCR)

    Time frame: through study completion, an average of 1 year

    defined as the proportion of patients who show no radiographic enlargement or recurrence of the primary tumor during follow-up

  4. Time to distant metastasis

    Time frame: through study completion, an average of 1 year

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Chang Chen

CONTACT

[email protected]

+86 21 65115006

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.