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A randomized, double-blind, parallel controlled trial for Icotinib double-dose first-line therapy for EGFR 21 exon mutations in advanced non-small cell lung cancer

A randomized, double-blind, parallel controlled trial for Icotinib double-dose first-line therapy for EGFR 21 exon mutations in advanced non-small cell lung cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046389
Enrollment
Unknown
Registered
2021-05-15
Start date
2021-07-01
Completion date
Unknown
Last updated
2021-12-21

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

Conditions

Non-small cell lung cancer

Interventions

Experimental group:Icotinib increase
Control group:Conventional dosage of Icotinib

Sponsors

Guangxi Medical University Affiliated Tumor Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with stage IIIB/IV newly treated non-small cell lung adenocarcinoma (or mixed adenocarcinoma components) who are not suitable for radical surgery or radiotherapy confirmed by histopathology, patients have received adjuvant chemotherapy and stopped the drug for more than 6 months can be selected ; 2. EGFR gene detection 19 exon mutation; 3. Aged >= 18 years; 4. ECOG 0-4 points; 5. Asymptomatic brain metastases; 6. There is imaging to assess the lesion, according to the evaluation standard of solid tumor efficacy (RECIST 1.1), there is at least one single-path measurable lesion, and the longest diameter is measured by spiral CT >= 10 mm (for any lesion that has received radiotherapy, it cannot as a target lesion); 7. Women of childbearing age must take a pregnancy test within 7 days before starting treatment and the result is negative; 8. Males of childbearing age need to take contraceptive measures during the period of surgical sterilization or treatment and within 3 months after the end.

Exclusion criteria

Exclusion criteria: 1. There are serious or uncontrollable systemic diseases (such as interstitial pneumonia or abnormal liver function); 2. Suffer from any other malignant tumors within five years (except for fully cured cervical carcinoma in situ or basal cell or squamous cell skin cancer); 3. Have a clear history of neurological or mental disorders, including epilepsy or dementia; 4. Pregnant or lactating women; 5. Evidence that there are any other important clinical abnormalities or laboratory test results that make the patient unsuitable to participate in the study.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;Overall survival;

Secondary

MeasureTime frame
Disease control rate;Objective response rate;Toxic side effects;

Countries

China

Contacts

Public ContactZeng Aiping

Guangxi Medical University Affiliated Tumor Hospital

zengaipingone@sina.com+86 771 5334955

Outcome results

None listed

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