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Neoadjuvant Icotinib With Chemotherapy for Epidermal Growth Factor Receptor(EGFR)-Mutated Resectable Lung Adenocarcinoma

NCT05132985 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2021-12-10

No results posted yet for this study

Summary

Icotinib is a first-generation inhibitor of EGFR-tyrosine kinase inhibitor in patients with non-small-cell lung cancer (NSCLC). Here we will evaluate neoadjuvant Icotinib with chemotherapy prior to surgery, in patients with resectable stage II-IIIB N2 EGFR mutation-positive NSCLC. The primary endpoint is centrally assessed major pathological response at the time of resection. Secondary endpoints include pathological complete response, objective response rate, R0 resection rate at the time of resection, disease-free survival, and overall survival. Safety and tolerability will also be assessed.

Conditions

  • NSCLC
  • EGF-R Positive Non-Small Cell Lung Cancer

Interventions

DRUG

Icotinib

125mg 1tt(Take 1 tablet 3 times a day) orally.

DRUG

Cisplatin

75 mg/m2 (IV，Q3W)

DRUG

Carboplatin

AUC 5 (IV, Q3W)

DRUG

Pemetrexed

500 mg/m2 (IV, Q3W)

Sponsors & Collaborators

  • Liaoning Cancer Hospital & Institute

    lead OTHER

Principal Investigators

  • Hongxu Liu, Doctor · Liaoning Cancer Hospital & Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-07-01
Completion
2028-01-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05132985 on ClinicalTrials.gov