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

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900025230

Enrollment

Unknown

Registered

2019-08-17

Start date

2019-09-15

Completion date

Unknown

Last updated

2019-08-27

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

A:Icotinib double dose

B:Icotinib

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients with non-small cell lung adenocarcinoma (or adenocarcinoma with initial stage IIIB/IV) that are not suitable for radical surgery or radiotherapy confirmed by pathological histology may be selected if they have been treated with adjuvant chemotherapy for more than 6 months; (2) EGFR gene detection 21 exon L858R mutation; (3) Aged 18-75 years old; (4) ECOG 0-3 points; (5) Asymptomatic brain metastasis; (6) There are imaging evaluable lesions. According to the solid tumor efficacy evaluation standard (RECIST 1.1), at least one single-path measurable lesion has a longest diameter measured by spiral CT >=10 mm. None of the lesions that have received radiotherapy can be used as target lesions; (7) Women of childbearing age must undergo a pregnancy test within 7 days before starting treatment and the result is negative; men of childbearing age: contraception is taken during the period of surgical sterilization or treatment and within 3 months after the end of treatment.

Exclusion criteria

Exclusion criteria: (1) There are serious or uncontrollable systemic diseases (such as interstitial pneumonia or abnormal liver function); (2) suffering from any other malignant tumor within five years (except for completely cured cervical carcinoma in situ or basal cell or squamous epithelial skin cancer); (3) A history of clear neurological or psychiatric disorders, including epilepsy or dementia; (4) pregnant or lactating women; (5) There are any other important clinical abnormalities or laboratory findings that make the patient unsuitable for participation in the study.

Design outcomes

Primary

Measure	Time frame
Progression-free survival;	—

Secondary

Measure	Time frame
Disease control rate;Objective response rate;AEs;	—

Countries

China

Contacts

Public ContactZeng Aiping

Guangxi Medical University Affiliated Tumor Hospital

zengaipingone@sina.com+86 0771-5334955

Outcome results

None listed

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