High-Dose Firmonertinib Plus Bevacizumab as Neoadjuvant Therapy for Resectable EGFRm Stage II-III… (NCT07182708) | Clinical Trial Compass
Not Yet RecruitingPhase 2
High-Dose Firmonertinib Plus Bevacizumab as Neoadjuvant Therapy for Resectable EGFRm Stage II-IIIB NSCLC
China62 participantsStarted 2025-10-01
Plain-language summary
This is a Phase II, single-arm, open-label, multicenter clinical study aimed at evaluating the efficacy and safety of Firmonertinib 160 mg combined with Bevacizumab as neoadjuvant therapy in patients with resectable stage II-IIIB Epidermal Growth Factor Receptor(EGFR)-mutated non-small cell lung cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female, aged ≥18 years.
✓. Histologically/cytologically confirmed primary non-small cell lung cancer within 60 days prior to the study.
✓. Stage II-IIIB disease evaluated by endobronchial ultrasound guided tranbronchial needle aspiration(EBUS-TBNA), mediastinoscopy, or Positron Emission Tomography/Computed Tomography (PET/CT), with lesions planned for radical resection after neoadjuvant therapy.
✓. EGFR mutation-positive confirmed by local laboratory testing of tissue or blood samples.
✓. Presence of at least one measurable lesion, with a baseline Computed Tomography (CT) scan showing the longest diameter ≥10 mm (except for lymph nodes, which must have a short axis ≥15 mm), and suitable for accurate repeated measurements.
✓. ECOG performance status score of 0-1, with no deterioration within 2 weeks prior to the first dose administration.
✓. Female patients should adopt fully effective contraceptive measures, must not be breastfeeding, and have a negative pregnancy test before the first administration of the study drug; or female patients must meet the following criteria at screening to confirm the absence of reproductive potential:
✓. Postmenopausal, defined as age greater than 50 years and amenorrhea for at least 12 months after cessation of all exogenous hormonal therapies.
Exclusion criteria
✕. Presence of small cell lung cancer or mixed pathological types of NSCLC. EGFR exon 20 insertion mutation detected by genetic testing.
What they're measuring
1
pathological Complete Response(pCR) rate
Timeframe: Within 24 hours after surgical resection
Trial details
NCT IDNCT07182708
SponsorPeking University Cancer Hospital & Institute
. Exposure to any other antitumor therapy prior to enrollment, including perioperative radiotherapy.
✕. The patient is in pregnancy or lactation.
✕. History of other malignant tumors, or currently combined with other malignant tumors (except for malignancies that have undergone radical surgery with no recurrence within 5 years post-operation, such as cervical carcinoma in situ, basal cell carcinoma of the skin, and papillary thyroid carcinoma, etc.).
✕. Presence of severe or uncontrolled systemic diseases requiring treatment, which the investigator deems unsuitable for trial participation, including hypertension, diabetes mellitus, chronic heart failure (New York Heart Association, NYHA Class III-IV), unstable angina, myocardial infarction within the past year, etc.
✕. Severe gastrointestinal dysfunction, diseases, or clinical conditions that may affect the intake, transport, or absorption of the study drug, such as inability to take oral medications, uncontrollable nausea and vomiting, extensive gastrointestinal resection history, etc.
✕. Any of the following laboratory tests indicate insufficient bone marrow reserve or organ reserve function.
✕. Known or suspected allergy to almonertinib mesylate, bevacizumab, or any other component of their formulations, or patients with other contraindications.