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EGFR Positive Non-small Cell Lung CancerPhase 2NCT03382795

Retreatment With Epidermal Growth Factor Receptor(EGFR) Tyrosine Kinase Inhibitor in EGFR Mutation Positive Patients

A Phase 2 study testing EGFR in people with EGFR Positive Non-small Cell Lung Cancer, run by Korea University Guro Hospital at 8 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In this trial, treatment efficacy and safety of retreatment with 1st generation epidermal growth factor receptor(EGFR) tyrosine kinase inhibitor(TKI)s(Gefitinib/Erlotinib), will be assessed in patients with sensitizing EGFR mutation positive Non-Squamous Cell Carcinoma patients who previously treated with EGFR TKI and… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
EGFR Positive Non-small Cell Lung Cancer
What is being tested?
EGFR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
8 sitesSouth Korea
Study dates
3 Jan 2018to 31 Mar 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females ≥ 19 years of age
  • Non Small Cell Lung Cancer(Non-Squamous Cell Carcinoma) patients who had shown clinical benefits (Complete response(CR) or Partial response(PR) or Stable disease(SD) ≥6 months) from EGFR-TKIs as first line treatment and developed progressive disease, and then received cytotoxic chemotherapy more than 4 cycles and developed progressive disease, and then confirmed T790 negative and sensitizing EGFR mutation(E19Del, L858R, L861Q, G719X, E19insertion) positive in Histologic, cytologic specimen or blood.
  • Patient with at least one measurable lesions according to RECIST v 1.1
  • Expected life expectancy ≥ 12 weeks
  • Eastern Cooperative Oncology Group(ECOG) performance status ≤ 2
  • Patients who have proper hematologic, renal and hepatic functions as follows:
Show all 14Show fewer
  • Absolute neutrophil count(ANC) ≥ 1,500/mm³
  • platelets ≥ 100,000/mm³
  • Hemoglobin ≥ 9g/dL
  • Total bilirubin ≤ 1.25 X UNL
  • Aspartate aminotransferase(AST or SGOT) and alanine aminotransferase(ALT or SGPT) ≤ 3.0 X UNL (if liver metastasis ≤5.0 X UNL)
  • Alkaline phosphatase ≤ 2.5 X UNL (if liver metastasis ≤5.0 X UNL)
  • Serum creatinine ≤ 1.5mg/dL
  • patients who are willing to comply with study procedure and voluntarily provide informed consent with signature

Who cannot join

  • Patients who have preexisting or coexisting malignancies in other parts except for effectively treated non-melanoma skin cancer, cervical carcinoma in situ(CIS) cervical cancer within the last 5 years
  • Patients with brain metastasis except for the followings:
  • Asymptomatic and stable brain metastases for which local treatment has been given: corticosteroids treatment isn't requiured for at least 2 weeks before starting the study treatment.
  • Patients currently receiving palliative radiation therapy or have toxicities from radiation therapy at screening.
  • Patients with clinically active history of interstitial lung disease(ILD), Drug induced ILD, Radiation pneumonitis
  • Patients with clinically significant cardiovascular disease or myocardial infarction within the past 12 months.
Show all 17Show fewer
  • Patients with active infection or severe systemic disease that are difficult to include in this study
  • Patients who received radiation therapy to target lesion of this study.
  • Patients who had major operation within 4 weeks before starting the study treatment and were not fully recovered.
  • Patients who were administered other study drugs within 4 weeks before starting the study treatment
  • Males and females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive pregnancy test prior to study entry
  • Patients who are difficult to include in this study in accordance with the investigator's judgment
  • Patients with histories of hypersensitivity to investigational product(IP) or any components of the agent
  • Patients with any of the following genetic predispositions including galactose intolerance, Lapp lactase deficiency, lactose intolerance or glucose-galactose malabsorption
  • Patient previously received cytotoxic chemotherapy within 2 weeks of IP administration
  • Patient received Immunotherapy prior to the study participation
  • Patients who are difficult to include in this study in accordance with the investigator's judgment due to severe adverse effects during previous EGFR TKI treatment

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

South Korea8 sites

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggi-do, 14068

  • Chungnam National University Hospital

    Daejeon, 35015

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128

  • Yonsei University Severance Hospital

    Seoul, 03722

  • Konkuk University Medical Center

    Seoul, 05030

  • Asan Medical Center

    Seoul, 05505

  • Korea University Guro Hospital

    Seoul, 08308

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do, 50612

Other trials in South Korea

About this study

Official title: Retreatment With 1st Generation EGFR TKIs in Sensitizing EGFR Mutation Positive Non-Squamous Cell Carcinoma Patients Who Previously Treated With EGFR TKI and Cytotoxic Chemotherapy

In this trial, treatment efficacy and safety of retreatment with 1st generation epidermal growth factor receptor(EGFR) tyrosine kinase inhibitor(TKI)s(Gefitinib/Erlotinib), will be assessed in patients with sensitizing EGFR mutation positive Non-Squamous Cell Carcinoma patients who previously treated with EGFR TKI and cytotoxic chemotherapy

Read the detailed description

This study is designed to be multi-center, open-label, single-arm, prospective, phase II trial of patient with sensitizing EGFR mutation positive Non-Squamous Cell Carcinoma patients who previously treated with EGFR TKI and cytotoxic chemotherapy. Approximately 69 patients will be enrolled into the trial, and expected study duration is 48 months from Institutional Review Board(IRB) and Korea Ministry of Food and Drug Safety(MFDS) approval date.

The study drug will be administered orally as one tablet(Gefitinib 250mg/ Erlotinib 150mg) once a day until disease progression or manifestation of unacceptable toxicity. The initial dose of the study drug daily can be reduced according to dose reduction criteria in protocol. A cycle of study treatment is defined as 28 days, and subjects will visit the site every 2 cycles(56 days).

Being tested
EGFR
Keywords
Epidermal growth factor receptor tyrosine kinase inhibitor, Cytotoxic chemotherapy, Epidermal growth factor receptor mutation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EGFRDrug

    Gefitinib 250mg or Erlotinib 150mg medication, Once-Daily.

Study groups in NCT03382795
Study groupRoleWhat they receive
EGFR retreat groupExperimentalNot described
Receives: Drug: EGFR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate(ORR) including rage of CR&PR

    Assessed on based of RECIST 1.1.

    Measured: Through study completion (5 years)

Secondary outcomes (3)

  1. Progression Free Survival, PFS

    Progression-free survival (PFS) the time from first dose of the study drug until the date of disease progression or death by any cause

    Measured: Through study completion (5 years)

  2. Overall Survival

    Overall Survival (OR) the time from first dose of the study drug until the date of death by any cause

    Measured: Through study completion (5 years)

  3. The incidence of Adverse Events(including Serious Adverse Events and Adverse Drug Reactions)

    Assessment on the base of NCI-CTCAE (version 4.03)

    Measured: Through study completion (5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2017
  2. Study start3 Jan 2018
  3. Primary completion31 Mar 2023 (estimated)
  4. Study completion31 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03382795
Sponsor's protocol ID
MLCSG2017001
Status last verified
Jul 2021
First submitted
19 Dec 2017
Last updated
15 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Janssen-Heijnen ML, Coebergh JW. The changing epidemiology of lung cancer in Europe. Lung Cancer. 2003 Sep;41(3):245-58. doi: 10.1016/s0169-5002(03)00230-7.

    PubMed 12928116

  • Jemal A, Chu KC, Tarone RE. Recent trends in lung cancer mortality in the United States. J Natl Cancer Inst. 2001 Feb 21;93(4):277-83. doi: 10.1093/jnci/93.4.277.

    PubMed 11181774

  • Kinoshita FL, Ito Y, Nakayama T. Trends in Lung Cancer Incidence Rates by Histological Type in 1975-2008: A Population-Based Study in Osaka, Japan. J Epidemiol. 2016 Nov 5;26(11):579-586. doi: 10.2188/jea.JE20150257. Epub 2016 Apr 30.

    PubMed 27150013

  • Dela Cruz CS, Tanoue LT, Matthay RA. Lung cancer: epidemiology, etiology, and prevention. Clin Chest Med. 2011 Dec;32(4):605-44. doi: 10.1016/j.ccm.2011.09.001.

    PubMed 22054876

  • Shin A, Oh CM, Kim BW, Woo H, Won YJ, Lee JS. Lung Cancer Epidemiology in Korea. Cancer Res Treat. 2017 Jul;49(3):616-626. doi: 10.4143/crt.2016.178. Epub 2016 Sep 23.

    PubMed 27669705

  • Jackman DM, Miller VA, Cioffredi LA, Yeap BY, Janne PA, Riely GJ, Ruiz MG, Giaccone G, Sequist LV, Johnson BE. Impact of epidermal growth factor receptor and KRAS mutations on clinical outcomes in previously untreated non-small cell lung cancer patients: results of an online tumor registry of clinical trials. Clin Cancer Res. 2009 Aug 15;15(16):5267-73. doi: 10.1158/1078-0432.CCR-09-0888. Epub 2009 Aug 11.

    PubMed 19671843

  • Mok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, Sunpaweravong P, Han B, Margono B, Ichinose Y, Nishiwaki Y, Ohe Y, Yang JJ, Chewaskulyong B, Jiang H, Duffield EL, Watkins CL, Armour AA, Fukuoka M. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009 Sep 3;361(10):947-57. doi: 10.1056/NEJMoa0810699. Epub 2009 Aug 19.

    PubMed 19692680

  • Maemondo M, Inoue A, Kobayashi K, Sugawara S, Oizumi S, Isobe H, Gemma A, Harada M, Yoshizawa H, Kinoshita I, Fujita Y, Okinaga S, Hirano H, Yoshimori K, Harada T, Ogura T, Ando M, Miyazawa H, Tanaka T, Saijo Y, Hagiwara K, Morita S, Nukiwa T; North-East Japan Study Group. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med. 2010 Jun 24;362(25):2380-8. doi: 10.1056/NEJMoa0909530.

    PubMed 20573926

  • Rosell R, Carcereny E, Gervais R, Vergnenegre A, Massuti B, Felip E, Palmero R, Garcia-Gomez R, Pallares C, Sanchez JM, Porta R, Cobo M, Garrido P, Longo F, Moran T, Insa A, De Marinis F, Corre R, Bover I, Illiano A, Dansin E, de Castro J, Milella M, Reguart N, Altavilla G, Jimenez U, Provencio M, Moreno MA, Terrasa J, Munoz-Langa J, Valdivia J, Isla D, Domine M, Molinier O, Mazieres J, Baize N, Garcia-Campelo R, Robinet G, Rodriguez-Abreu D, Lopez-Vivanco G, Gebbia V, Ferrera-Delgado L, Bombaron P, Bernabe R, Bearz A, Artal A, Cortesi E, Rolfo C, Sanchez-Ronco M, Drozdowskyj A, Queralt C, de Aguirre I, Ramirez JL, Sanchez JJ, Molina MA, Taron M, Paz-Ares L; Spanish Lung Cancer Group in collaboration with Groupe Francais de Pneumo-Cancerologie and Associazione Italiana Oncologia Toracica. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2012 Mar;13(3):239-46. doi: 10.1016/S1470-2045(11)70393-X. Epub 2012 Jan 26.

    PubMed 22285168

  • Sequist LV, Yang JC, Yamamoto N, O'Byrne K, Hirsh V, Mok T, Geater SL, Orlov S, Tsai CM, Boyer M, Su WC, Bennouna J, Kato T, Gorbunova V, Lee KH, Shah R, Massey D, Zazulina V, Shahidi M, Schuler M. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013 Sep 20;31(27):3327-34. doi: 10.1200/JCO.2012.44.2806. Epub 2013 Jul 1.

    PubMed 23816960

  • Yu HA, Arcila ME, Rekhtman N, Sima CS, Zakowski MF, Pao W, Kris MG, Miller VA, Ladanyi M, Riely GJ. Analysis of tumor specimens at the time of acquired resistance to EGFR-TKI therapy in 155 patients with EGFR-mutant lung cancers. Clin Cancer Res. 2013 Apr 15;19(8):2240-7. doi: 10.1158/1078-0432.CCR-12-2246. Epub 2013 Mar 7.

    PubMed 23470965

  • Besse B, Adjei A, Baas P, Meldgaard P, Nicolson M, Paz-Ares L, Reck M, Smit EF, Syrigos K, Stahel R, Felip E, Peters S; Panel Members; ESMO. 2nd ESMO Consensus Conference on Lung Cancer: non-small-cell lung cancer first-line/second and further lines of treatment in advanced disease. Ann Oncol. 2014 Aug;25(8):1475-84. doi: 10.1093/annonc/mdu123. Epub 2014 Mar 25.

    PubMed 24669016

  • Asahina H, Oizumi S, Inoue A, Kinoshita I, Ishida T, Fujita Y, Sukoh N, Harada M, Maemondo M, Saijo Y, Dosaka-Akita H, Isobe H, Nukiwa T, Nishimura M; Hokkaido Lung Cancer Clinical Study Group. Phase II study of gefitinib readministration in patients with advanced non-small cell lung cancer and previous response to gefitinib. Oncology. 2010;79(5-6):423-9. doi: 10.1159/000326488. Epub 2011 Apr 8.

    PubMed 21474967

  • Koizumi T, Agatsuma T, Ikegami K, Suzuki T, Kobayashi T, Kanda S, Yoshikawa S, Kubo K, Shiina T, Takasuna K, Matsuo A, Hayasaka M, Morikawa M, Ameshima S. Prospective study of gefitinib readministration after chemotherapy in patients with advanced non-small-cell lung cancer who previously responded to gefitinib. Clin Lung Cancer. 2012 Nov;13(6):458-63. doi: 10.1016/j.cllc.2012.01.006. Epub 2012 Mar 7.

    PubMed 22402083

  • Oh IJ, Ban HJ, Kim KS, Kim YC. Retreatment of gefitinib in patients with non-small-cell lung cancer who previously controlled to gefitinib: a single-arm, open-label, phase II study. Lung Cancer. 2012 Jul;77(1):121-7. doi: 10.1016/j.lungcan.2012.01.012. Epub 2012 Feb 12.

    PubMed 22333554

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EGFR in people with EGFR Positive Non-small Cell Lung Cancer, run by Korea University Guro Hospital at 8 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate(ORR) including rage of CR&PR (time frame: Through study completion (5 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03382795, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.

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