PRe-Operative Gefitinib in Resectable EGFR Mutation Positive Lung Cancer With Sector Sequencing for Biomarker Discovery

NCT02804776 | Completed Phase 2

• 1 other identifier: ECRU-LUNG-2013
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pharmacodynamic study to evaluate the effect of gefitinib as induction therapy for patients who have resectable, Epidermal growth factor receptor (EGFR) sensitizing mutation lung cancer.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• EGFR TKI sensitivity biomarkers determination

  Determine EGFR tyrosine kinase inhibitor (TKI) sensitivity biomarkers in responders vs non responders, as categorized by either Response Evaluation Criteria In Solid Tumors (RECIST) stable disease (SD) vs Partial response (PR) or median percentage tumour shrinkage

  4 to 6 weeks

Secondary Outcomes (1)

• Response rates after 4 weeks of neoadjuvant gefitinib

  4 to 6 weeks

Other Outcomes (2)

• Clonal heterogeneity using whole exome and RNA-sequencing of tumour sectors as well as resected lymph nodes

  4 to 6 weeks

• Clonal heterogeneity recapitulation through CTC, plasma DNA and functional imaging

  4 to 6 weeks

Study Arms (1)

Gefitinib

EXPERIMENTAL

Gefitinib 250mg oral daily will be given for 4 weeks prior to surgery

Drug: Gefitinib

Interventions

Gefitinib DRUG

250mg oral daily for 4 weeks

Also known as: Iressa

Gefitinib

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• EGFR mutation positive Non-Small Cell lung cancer (NSCLC) (regardless of smoking status), or control group may encompass other molecular subtypes of lung cancer e.g. anaplastic lymphoma kinase (ALK) and Kirsten rat sarcoma viral oncogene homolog (KRAS).
• All early stage patients with NSCLC who are deemed surgically resectable.
• All patients must have histologically proven NSCLC, with known EGFR mutation
• Patients should be fit for either lobectomy/ pneumonectomy with or without lymph node sampling.
• Primary tumour should be at least 2 cm in size (Tumor stage 1b).
• Willing to provide informed consent.

You may not qualify if:

• Known severe hypersensitivity to gefitinib or any of the excipients of this product
• Any serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
• Interstitial lung disease (ILD) or pulmonary fibrosis; impaired pulmonary function (e.g. FEV1 \<40% predicted value, artery blood gas PaO2\<60mmHg)
• Patients with prior exposure to agents directed at the Human epidermal receptor (HER) axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
• Patients with prior exposure to chemotherapy, irradiation or systemic anti-cancer therapy (e.g. monoclonal antibody therapy) for lung cancer.
• Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within six months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
• 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.
• Patient who has serious active infection.
• Patients who harbouring exon 20 T(Threonine)790M (Methionine) mutation.
• Pregnancy or breast feeding.

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead

Study Sites (1)

National Cancer Centre

Singapore, 169610, Singapore

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gefitinib

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

• Daniel SW Tan

  National Cancer Centre, Singapore

  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

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 17, 2016
• Study Start: January 27, 2015
• Primary Completion: February 21, 2018
• Study Completion: February 21, 2018
• Last Updated: June 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)