Adjuvant Furmonertinib in Stage IA With High Risk Factors and Stage IB Non-small Cell Lung Cancer (NCT05445310) | Clinical Trial Compass
RecruitingPhase 2
Adjuvant Furmonertinib in Stage IA With High Risk Factors and Stage IB Non-small Cell Lung Cancer
China114 participantsStarted 2022-08-06
Plain-language summary
This is a prospective, single arm study to investigate the efficacy and safety furmonertinib 80mg/d as adjuvant treatment for 3 years post surgery of stage IA with high-risk factors and stage IB non-small cell lung cancer. A total of 114 patients would be enrolled. The primary endpoint is the disease-free survival rate at 3 years.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Received radical resection of non-small cell lung cancer without prior anti-tumor therapies including radiotherapy, chemotherapy, target therapy and immunotherapy.
* Histologically diagnosed Non-small cell lung cancer based on the judgement of at least 2 pathologists.
* Stage IA with high risk factors including micropapillae or solid components, vascular invasion, spread through air spaces, low differentiation, tumor budding and insufficient lymph node dissection; Stage IB with or without high-risk factors. The pathological stage is based on the 8th edition of AJCC lung cancer staging.
* EGFR mutation positive according to NGS testing by tissue, including deletions in exon 19, L858R, S768I, G719X, L861Q, T790M mutations et al.
* ECOG performance status 0-1.
* Sufficient organ function in liver, renal, kidney and hematology.
* With written signed informed consent form, ability to report adverse events, and good adherence to clinical study.
Exclusion Criteria:
* Lung cancer with small cell or neuroendocrine cancer cell.
* EGFR exon 20 insertion positive.
* Concurrent with other diver mutations including alterations in ALK, ROS1, MET et al.
* Women who are pregnant or breastfeeding.
* Use of CYP3A4 strong depressant within 7 days or CYP3A4 strong inducer within 21 days prior to initial administration, use of other anti-tumor treatment including traditional Chinese medicine within 14 days before enrollment.
* Concurrent with other malignancies excluding c…
What they're measuring
1
Disease-free survival rate at 3 years
Timeframe: 3 years following the first dose of study drug