High-dose Icotinib Treatment Beyond Progression in EGFR Mutant NSCLC

A Phase II Study of High-dose Icotinib in Previously Treated Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor Mutation

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02960607

Enrollment

Registered

2016-11-09

Start date

2016-11-30

Completion date

Unknown

Last updated

2016-11-18

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

Conditions

Carcinoma, Non-Small-Cell Lung

Brief summary

The purpose of this study is to investigate whether high-dose icotinib treatment beyond disease progression is beneficial for NSCLC patients who have EGFR mutation and who have responded to EGFR TKI.

Interventions

DRUGIcotinib

Icotinib (250mg tid) until disease progression or unacceptable toxicities occurred.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Histologically confirmed stage IIIB/IV NSCLC * Investigator confirmed progression according RECIST 1.1 during previous icotinib treatment * Patients whose tumors: * are EGFR mutation-positive or * T790M mutation-negative * Performance status: WHO 0-2 * Measurable disease according to RECIST 1.1 * at least one measureable lesion .if only one measureable lesion, the biological nature must be confirmed by cytology or histology * a single diameter of lesion could be measured by at least one of the following methods: Chest or abdominal computed tomography(CT)or magnetic resonance imaging(MRI),conventional methods of diameter at least 20mm diameter spiral CT OR at least 10mm * ANC ≥ 1.5\*109/L, Platelets ≥ 75\*109/L, Hgb≥ 9g/dL, Alanine amino transferase ≤ 2 × Upper limit of normal (ULN), Alkaline phosphatase ≤ 2.5 × ULN (\< 5 × ULN if liver metastases), Serum Creatinine ≤ 1.5 × ULN * Women of childbearing age must have a pregnancy test 7 days before treatment and the result were negative ,men of childbearing age: surgical sterilization or treatment during and after the end of three months to take contraceptive measures * Patient must be able to comply with the protocol

Exclusion criteria

* Patient with symptomatic central nervous system metastases * Patient has known active hepatitis B or C, or HIV infection * Pregnant or breastfeeding. * Patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the study

Design outcomes

Primary

Measure	Time frame
Progression Free survival	2 years

Countries

China

Contacts

Primary ContactYutao Liu

13911901165@139.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026