NCT00588445

Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene in Patients With NSCLC

Completed Phase 2 Results posted Last updated 17 December 2015

What this trial tests

Phase 2 trial testing Gefitinib in Lung Cancer in 65 participants. Completed in 1 September 2010.

Timeline

1 June 2004

Primary endpoint
1 September 2010

1 September 2010

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	65
Start date	1 June 2004
Primary completion	1 September 2010
Estimated completion	1 September 2010
Sites	1 location across United States

Drugs / interventions tested

• Gefitinib (gefitinib) — full drug profile →

Conditions studied

• Lung Cancer — all drugs for Lung Cancer →
• Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
• Bronchioloalveolar Cancer — all drugs for Bronchioloalveolar Cancer →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, any sex, with Lung Cancer or Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The Radiographic Response to Gefitinib
  Time frame: 21 days
  Radiographic response is defined as a minor response ( \> 25% decrease in the sum of the products of measured lesions)

Sponsor's own description

The purpose of this research study is to:

* see if gefitinib pills can shrink Stage 1 or 2 non-small cell lung cancers before surgery
* see if your non-small cell lung cancer has a mutation in a certain part of the EGFR gene
* see if patients whose tumor does shrink with gefitinib treatment are more likely to have a mutation in a certain part of the EGFR gene
* see if the pattern of protein expression in the blood is related to the tumor's sensitivity or resistance to gefitinib treatment.
* see if expression of certain genes in the tumor are related to the tumor's sensitivity or resistance to gefitinib treatment.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Identification of Non-Small Cell Lung Cancer Sensitive to Systemic Cancer Therapies Using Radiomics.
   Dercle L, Fronheiser M, Lu L, Du S, et al · · 2020 · cited 138× · PMID 32198149 · DOI 10.1158/1078-0432.ccr-19-2942
2. A pilot study of volume measurement as a method of tumor response evaluation to aid biomarker development.
   Zhao B, Oxnard GR, Moskowitz CS, Kris MG, et al · · 2010 · cited 79× · PMID 20534736 · DOI 10.1158/1078-0432.ccr-10-0125
3. Identifying Robust Radiomics Features for Lung Cancer by Using In-Vivo and Phantom Lung Lesions.
   Lu L, Sun SH, Afran A, Yang H, et al · · 2021 · cited 9× · PMID 33681463 · DOI 10.3390/tomography7010005