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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Pulmonary Hospital, Shanghai, China

About this 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?

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • furmonertinib
  • ablation
  • stereotactic body radiotherapy

Treatment groups

45 Participants
are divided into 1 treatment group