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Not yet taking people in ChinaPhase 2

Furmonertinib plus ablation or radiotherapy for early lung cancer when surgery is not possible

Tests furmonertinib with local treatment in early non-small cell lung cancer without surgery.

Key facts

Who runs it
Shanghai Pulmonary Hospital, Shanghai, China
Where
Shanghai, ChinaSee the site
Trial code
Registry title
Combining Furmonertinib With Local Therapy for Inoperable Early-stage Lung Cancer: A Phase II Trial
Status
Not yet recruiting
Phase
Phase 2
People taking part
45 people, planned
Started
1 Apr 2026
Expected to end
31 Aug 2028
Type of study
Interventional
Treatments tested
  • furmonertinib
  • ablation
  • stereotactic body radiotherapy
Record updated
8 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with early-stage non-small cell lung cancer who have an EGFR mutation and cannot have surgery or refuse it.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Early-stage T1-3 N0 non-small cell lung cancer, or several primary lesions or one lung recurrence in the lung tissue. Doctors must judge surgery not possible, or the person refuses surgery. The lung lesions must be treatable with ablation or radiotherapy.
Earlier treatment
No radiotherapy meant to remove all of the disease within 3 months before the first dose. No major surgery within 28 days before the first dose.
Biomarker or test result
An EGFR-sensitive mutation confirmed by genetic testing, such as Exon 19 deletion, L858R, G719X, L861Q, S768I, or combinations of these.

Main reasons for not taking part

  • Severe allergic reaction (grade 3 or higher) to any monoclonal antibody or any part of the study drug
  • Known reason that rules out ablation or radiotherapy
  • Active infection needing treatment with anti-infective drugs within 14 days before the first dose
  • Hepatitis B or hepatitis C with detectable virus
  • Taking part in another clinical trial within 3 months or 5 half-lives, whichever is longer

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Known contraindications to ablation or radiotherapy
  • Active infection requiring systemic anti-infective therapy within 14 days prior to the first dose
  • 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
  • Known severe allergic reaction (NCI-CTCAE v5.0 grade ≥ 3) to any monoclonal antibody or any excipient of the study drug
  • Failure to meet the minimum requirements for target coverage and dose constraints to organs at risk in the SABR treatment plan
  • 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)
  • Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study

Where in China

  • Shanghai Pulmonary HospitalShanghai, ChinaContact: Chang ChenNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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?

The group in the trial

  • Local therapyTreatment being tested

    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.

    Treatment: furmonertinib, ablation, and stereotactic body radiotherapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Furmonertinib plus ablation or radiotherapy for early lung cancer when surgery is not possibleGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
8 April 2026