NCT02851329

Brief Summary

The investigators propose a non-invasive prognostic tool for TKIs resistance in patients with stage IV EGFR-mutant non-small cell lung cancer (NSCLC) by computed tomography phenotypic features, which can be conveniently translated to facilitate the pre-therapy individualized management of EGFR TKIs in this disease.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

2.1 years

First QC Date

July 28, 2016

Last Update Submit

January 17, 2017

Conditions

Non-small Cell Lung Cancer

Keywords

stage IV EGFR-mutantEGFR TKIsprogression-free survivalprognosiscomputed tomography

Outcome Measures

Primary Outcomes (1)

  • progression-free survival

    3 years

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Currently, a cohort of 300 patients has already been collected from the collaborating hospitals. Next, the 3 hospitals will collect at least 200 patients within 1 years.

You may qualify if:

  • Eligible patients were diagnosed with NSCLC, and stage IV according to the TNM system classification of the American Joint Committee on Cancer.
  • Presence of activating EGFR mutations.
  • Age 20 years or older, and no history of systemic anticancer therapy for advanced disease.
  • All patients had to be capable of undergoing contrast-enhanced CT, and pretreatment CT was strictly controlled in two weeks before the EGFR TKIs starts.

You may not qualify if:

  • Based on the criteria above, patients who underwent resection for local advanced or metastatic disease were withdrawn from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Key Laboratory of Molecular Imaging, Chinese Academy of Sciences

Beijing, Beijing Municipality, 100190, China

Location

Related Publications (5)

  • Crystal AS, Shaw AT, Sequist LV, Friboulet L, Niederst MJ, Lockerman EL, Frias RL, Gainor JF, Amzallag A, Greninger P, Lee D, Kalsy A, Gomez-Caraballo M, Elamine L, Howe E, Hur W, Lifshits E, Robinson HE, Katayama R, Faber AC, Awad MM, Ramaswamy S, Mino-Kenudson M, Iafrate AJ, Benes CH, Engelman JA. Patient-derived models of acquired resistance can identify effective drug combinations for cancer. Science. 2014 Dec 19;346(6216):1480-6. doi: 10.1126/science.1254721. Epub 2014 Nov 13.

    PMID: 25394791BACKGROUND

  • Seto T, Kato T, Nishio M, Goto K, Atagi S, Hosomi Y, Yamamoto N, Hida T, Maemondo M, Nakagawa K, Nagase S, Okamoto I, Yamanaka T, Tajima K, Harada R, Fukuoka M, Yamamoto N. Erlotinib alone or with bevacizumab as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harbouring EGFR mutations (JO25567): an open-label, randomised, multicentre, phase 2 study. Lancet Oncol. 2014 Oct;15(11):1236-44. doi: 10.1016/S1470-2045(14)70381-X. Epub 2014 Aug 27.

    PMID: 25175099BACKGROUND

  • Lambin P, van Stiphout RG, Starmans MH, Rios-Velazquez E, Nalbantov G, Aerts HJ, Roelofs E, van Elmpt W, Boutros PC, Granone P, Valentini V, Begg AC, De Ruysscher D, Dekker A. Predicting outcomes in radiation oncology--multifactorial decision support systems. Nat Rev Clin Oncol. 2013 Jan;10(1):27-40. doi: 10.1038/nrclinonc.2012.196. Epub 2012 Nov 20.

    PMID: 23165123BACKGROUND

  • Balachandran VP, Gonen M, Smith JJ, DeMatteo RP. Nomograms in oncology: more than meets the eye. Lancet Oncol. 2015 Apr;16(4):e173-80. doi: 10.1016/S1470-2045(14)71116-7.

    PMID: 25846097BACKGROUND

  • Miller VA, Hirsh V, Cadranel J, Chen YM, Park K, Kim SW, Zhou C, Su WC, Wang M, Sun Y, Heo DS, Crino L, Tan EH, Chao TY, Shahidi M, Cong XJ, Lorence RM, Yang JC. Afatinib versus placebo for patients with advanced, metastatic non-small-cell lung cancer after failure of erlotinib, gefitinib, or both, and one or two lines of chemotherapy (LUX-Lung 1): a phase 2b/3 randomised trial. Lancet Oncol. 2012 May;13(5):528-38. doi: 10.1016/S1470-2045(12)70087-6. Epub 2012 Mar 26.

    PMID: 22452896BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jiangdian Song, Ph.D.

    CAS Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 1, 2016

Study Start

February 1, 2015

Primary Completion

March 1, 2017

Study Completion

July 1, 2017

Last Updated

January 19, 2017

Record last verified: 2017-01

Locations

CN(1)