Combining Furmonertinib With Local Therapy for Inoperable Early-stage Lung Cancer: A Phase II Trial (NCT07517640) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Combining Furmonertinib With Local Therapy for Inoperable Early-stage Lung Cancer: A Phase II Trial
China45 participantsStarted 2026-04-01
Plain-language 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?
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
2-year EFS rate
Timeframe: Within two years after the treatment
Trial details
NCT IDNCT07517640
SponsorShanghai Pulmonary Hospital, Shanghai, China