Erlotinib as Neoadjuvant Treatment in Patients With Stage ⅢA N2 NSCLC With Activating EGFR Mutation.

NCT01217619 | Completed Phase 2

• 1 other identifier: ML25444
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm, one center, phaseⅡ study evaluating efficacy and safety of erlotinib as neoadjuvent treatment in patients with EBUS confirmed stage ⅢA N2 NSCLC with activating EGFR mutation in exon 19 or 21.

Conditions

Non Small Cell Lung Cancer

Keywords

neoadjuvant treatment

Outcome Measures

Primary Outcomes (1)

• radical resection rate

  To evaluate radical resection rate of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ⅢA N2 NSCLC with EGFR mutation in exon 19 or 21.

  operation after effective neoadjuvant treatment of tarceva for 56 days

Secondary Outcomes (7)

• Pathological Complete Remission

  operation after effective neoadjuvant treatment of tarceva for 56 days

• Objective Response Rate

  Objective Response Rate measured by RECIST criteria in ITT population treated by erlotinib

• disease free survival

  From surgery to disease relapse or death

• overall survival

  From study treatment to death due to any cause

• quality of life

  During study treatment period

Study Arms (1)

Erlotinib

EXPERIMENTAL

Single-arm

Drug: erlotinib

Interventions

erlotinib DRUG

erlotinib 150mg/d continuously for 56 days

Also known as: Tarceva

Erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent provided. Males or females aged ≥18 years. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
• Stage IIIA N2 NSCLC according to the pathological evidence of endobronchial ultrasound(EBUS).
• The biopsy specimen shows EGFR mutation in exon 19 or 21 by DNA sequencing. Measurable disease must be characterized according to RECIST criteria: measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20cm with conventional techniques (PE, CT, XR, MRI) or as ≥ 10cm with spiral scan.
• ECOG performance status 0-1. Life expectancy ≥12 weeks.
• Female subjects should not be pregnant or breast-feeding.

You may not qualify if:

• The biopsy specimen shows EGFR wildtype in exon 19 or 21 by DNA sequencing. Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
• Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy).
• Known hypersensitivity to Tarceva or any of its recipients.
• Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the subject at high risk for treatment-related complications.
• Sexually active males and females(of childbearing potential) unwilling to practice contraception during the study.

Sponsors & Collaborators

• Baohui Han: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (2)

• Xiong L, Lou Y, Bai H, Li R, Xia J, Fang W, Zhang J, Han-Zhang H, Lizaso A, Li B, Gu A, Han B. Efficacy of erlotinib as neoadjuvant regimen in EGFR-mutant locally advanced non-small cell lung cancer patients. J Int Med Res. 2020 Apr;48(4):300060519887275. doi: 10.1177/0300060519887275. Epub 2019 Dec 29.

  PMID: 31885349 DERIVED

• Xiong L, Li R, Sun J, Lou Y, Zhang W, Bai H, Wang H, Shen J, Jing B, Shi C, Zhong H, Gu A, Jiang L, Shi J, Fang W, Zhao H, Zhang J, Wang J, Ye J, Han B. Erlotinib as Neoadjuvant Therapy in Stage IIIA (N2) EGFR Mutation-Positive Non-Small Cell Lung Cancer: A Prospective, Single-Arm, Phase II Study. Oncologist. 2019 Feb;24(2):157-e64. doi: 10.1634/theoncologist.2018-0120. Epub 2018 Aug 29.

  PMID: 30158288 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Baohui Han, MD

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 8, 2010
• Study Start: March 2, 2011
• Primary Completion: June 30, 2016
• Study Completion: October 30, 2016
• Last Updated: September 12, 2017

Record last verified: 2017-09

Locations

CN (1)