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An Observational Study of EGFR Mutation-Positive Non-Small Cell Lung Cancer Patients Treated with Furmonertinib Mesilate Tablets

An Observational Study of EGFR Mutation-Positive Non-Small Cell Lung Cancer Patients Treated with Furmonertinib Mesilate Tablets

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500101506
Enrollment
Unknown
Registered
2025-04-25
Start date
2024-06-07
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EGFR mutation positive non-small cell lung cancer patients, including: 1) First-line treatment for patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. 2) Second-line treatment for patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR T790M mutations who have progressed

Interventions

Observation group:None

Sponsors

Shanghai Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with EGFR mutation-positive non-small cell lung cancer, including: (1) First-line treatment of patients with locally advanced or metastatic non-small cell lung cancer with GFR exon 19 deletion or exon 21 (L858R) replacement mutations; (2) second-line treatment for patients with EGFR T790M mutation-positive locally advanced or metastatic non-small cell lung cancer who have failed prior EGFR-TKI therapy; (3) postoperative adjuvant therapy for patients with EGFR exon 19 deletion or exon 21 (L858R) replacement mutation in IA high-risk-stage III.A non-small cell lung cancer; (4) locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion (Exon 20ins) mutations. 2. Is using or planning to start treatment with fumetinib mesylate tablets (Ifsha ®); 3. Patients who can obtain informed consent (signed by themselves or their guardians).

Exclusion criteria

Exclusion criteria: 1) Patients with contraindications to the use of Furmonertinib Mesylate Tablets , as per the drug’s prescribing information; 2) Patients who have had any malignancy other than non-small cell lung cancer within the past 5 years, except for locally curable cancers that have been completely resolved and require no further treatment; 3) Patients who can obtain informed consent (signed by themselves or their guardians).

Design outcomes

Primary

MeasureTime frame
Progression free survival (PFS);

Secondary

MeasureTime frame
Incidence of adverse reactions (ADRs) in patients treated with fumetinib mesylate tablets (Ifxa ?).;Overall survival (OS);Characteristics of the patient and characteristics of the disease;Treatment mode;

Countries

China

Contacts

Public ContactHua Zhong

Shanghai Chest Hospital

eddiedong8@hotmail.com+86 21 22200000

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026