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A Multicentre Real-World Study to Assess the Efficacy and Safety of Ametinib Mesylate Tablets in Combination with Vinorelbine Tartrate Soft Capsules Against Ametinib Monotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR-Sensitive Mutations

A Multicentre Real-World Study to Assess the Efficacy and Safety of Ametinib Mesylate Tablets in Combination with Vinorelbine Tartrate Soft Capsules Against Ametinib Monotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR-Sensitive Mutations

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090618
Enrollment
Unknown
Registered
2024-10-10
Start date
2024-10-15
Completion date
Unknown
Last updated
2024-10-15

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

Conditions

Lung cancer

Interventions

Ametinib mesylate monotherapy group:Administration of ametinib mesylate
Amitinib combined with vincristine group:Co-administration of amitinib and vincristine

Sponsors

Anhui Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients were enrolled only if they met all of the following criteria: 1) Age: =18 years, male or female; 2) Patients with locally advanced or metastatic non-small cell lung cancer with EGFR-sensitive mutations who have not received prior systemic anti-tumour therapy for locally advanced or metastatic non-small cell lung cancer. 3) Patients who, in the opinion of the investigator, would benefit from treatment with alectinib or alectinib in combination with vincristine; 4) Approved by the Ethics Committee, the patient voluntarily participates in this study, signs the informed consent, is compliant, and cooperates with the treatment and follow-up.

Exclusion criteria

Exclusion criteria: Anyone with one of the following conditions will not be selected: 1) Pregnant or lactating women; 2) Patients with contraindications to amitriptyline or EGFR-TKIs (e.g., active bleeding, ulcers, intestinal perforation, intestinal obstruction, hypertension uncontrollable by medication, class III-IV cardiac insufficiency, within 30 days of major surgery, severe hepatic or renal insufficiency, etc.); 3) Those whom the doctor considers unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate, ORR;

Secondary

MeasureTime frame
Progression-Free Survival, PFS;Disease Control Rate, DCR;Duration of Overall Response, DOR;Overall Survival, OS;Security Indicators;

Countries

China

Contacts

Public ContactShi Qingming

Anhui Chest Hospital

shqm0324@163.com+86 130 6349 5524

Outcome results

None listed

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