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Non Small Cell Lung CancerPhase 2NCT05469022

Neoadjuvant Lazertinib Therapy in EGFR-Mutation Positive Lung Adenocarcinoma Detected by BALF Liquid Biopsy

A Phase 2 study testing Neoadjuvant lazertinib in people with Non Small Cell Lung Cancer, run by Konkuk University Medical Center at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Complete surgical resection is the standard treatment in early-stage lung cancer. However, the patients with early resected Epidermal Growth Factor Receptor(EGFR)-mutated lung cancers have high recurrence rate. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Neoadjuvant lazertinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSouth Korea
Study dates
19 May 2022to 19 May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Age ≥ 19 years
  • Patients with suspected lung cancer on chest CT findings
  • Patients with the following EGFR gene mutations in the test on bronchoalveolar lavage fluid: E19Del, L858R alone or concurrent rare EGFR gene mutations (T790M, G719X, exon 20 insertion, S768I)
  • Patients whose tumor can be completely resected by surgery: patients with stage I-IIIB, or stage IVA who has single metastasis
  • Patients not previously treated with EGFR-TKIs such as gefitinib, erlotinib, afatinib, dacomitinib
  • Patients with the measurable lesion of 1 cm or more according to RECIST v1.1
Show all 12Show fewer
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • EGFR-TKIs (gefitinib, erlotinib, afatinib,dacomitinib) naive patients
  • Patients with adequate pulmonary and heart function for surgery
  • Adequate organ function defined as Hemoglobin ≥ 9.0g/dL Absolute neutrophil count ≥ 1500/mm3 Platelet ≥ 100,000 /mm3 Serum creatinine≤ normal range*1.5x Aminotransferase/Alkaline phosphatase ≤normal range*2.5x Total bilirubin ≤1.5 mg/dL Liver metastasis: Aminotransferase/Alkaline phosphatase ≤ normal range* 5x Bone metastasis Alkaline phosphatase ≤ normal range* 5x
  • Female patients with childbearing potential should be using adequate contraceptive measures. Female patients must have evidence of non-child-bearing potential(Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments)
  • Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception for at least 14 days prior to administration of the first dose of study treatment, during the study, and for 3 months following the last dose of Lazertinib.

Who cannot join

  • Uncontrolled active interstitial lung disease
  • Pathologically confirmed N3 disease
  • Uncontrolled stage III-IV other malignancy
  • Uncontrolled Hypertension, Congestive Heart failure with New York Heart Association(NYHA) ≥ 3, acute myocardial infarct history within 6 months before screening. 2nd- 3rd Atrio-Ventricular(AV) block or complete AV block
  • Gastrointestinal diseases (e.g. Chron's disease, ulcerative colitis) or malabsorption syndrome that would impact on drug absorption
  • Active infection requiring ongoing treatment(e.g. active Hepatitis B virus, Hepatitis C virus or Human immunodeficiency virus)
  • History of hypersensitivity to active or inactive excipients of Lazertinib or drugs with a similar chemical structure.
  • No ability to comply with protocol requirements.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

In Ae Kim, MD. PhD. contact

+821035438353

20180618@kuh.ac.kr

Kye Young Lee, MD,PhD. contact

821088963916

kyleemd@kuh.ac.kr

South Korea1 site, 1 recruiting

  • Konkuk University Medical Center

    Seoul, 05030

    In Ae Kim, M.D. Ph.D.

    Recruiting

Other trials in South Korea

About this study

Official title: A Phase II, Single-Center, Single-Arm, Prospective Study of Neoadjuvant Lazertinib Therapy in Resectable EGFR-Mutation Positive Lung Adenocarcinoma Patients Detected by Broncho-alveolar Lavage Fluid(BALF) Liquid Biopsy

Complete surgical resection is the standard treatment in early-stage lung cancer. However, the patients with early resected Epidermal Growth Factor Receptor(EGFR)-mutated lung cancers have high recurrence rate. The efficacy of neoadjuvant treatment by first-generation EGFR-Tyrosine Kinase Inhibitor(TKI) has been demonstrated, however, that of the third-generation EGFR-TKI(lazertinib) has not yet been fully investigated. The aim of this study is to evaluate the efficacy of neoadjuvant Lazertinib in resectable EGFR mutation-positive NSCLC and clinical application of extracellular vesicles(EVs) based BALF liquid biopsy to identify EGFR mutation without invasive tissue biopsy.

Read the detailed description

The neoadjuvant treatment of 3rd-generation EGFR-TKI, lazertinib for 9 weeks before surgery is administrated. After the surgery, the patients with the tumor over stage 2 are given the lazertinib to prevent recurrence for 3 years or until recurrence. In early lung cancer, a tissue biopsy is often difficult due to the small size or the risky location. We collect bronchoalveolar lavage fluid for liquid biopsy and lazertinib is administrated according to the result of BALF liquid EGFR genotyping.

Being tested
Neoadjuvant lazertinib
Keywords
EGFR mutation, extracellular vesicle, bronchoalveolar lavage, liquid biopsy, lazertinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • Neoadjuvant lazertinibDrug

    Also called Neoadjuvant LECLAZA

    Lazertinib 240mg p.o once daily.

Study groups in NCT05469022
Study groupRoleWhat they receive
Neoadjuvant LazertinibExperimentalLazertinib as neoadjuvant treatment is administrated for 9 weeks before surgery. After surgical intervention the treatment is administrated upto 3 years to the patients with over stage 2 tumor. Treatment is discontinued in case of unacceptable toxicity or disease progression.
Receives: Drug: Neoadjuvant lazertinib

What is being measured

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

  1. Objective response rate

    The objective response rate (ORR) evaluated with RECIST version 1.1. It is defined as the proportion of patients with complete response (CR) or partial response (PR) after 9 weeks of lazertinib administration

    Measured: 9 weeks after the starting day of the lazertinib

Secondary outcomes (4)

  1. Down-staging rate

    The rate of downstage by pathology stage compared with clinical stage

    Measured: From the day of screening to an average of 16 weeks after the first dose

  2. Major pathological response

    The proportion of patients with less than 10% of the cancer cells in the surgical sample.

    Measured: From the day of screening to an average of 16 weeks after the first dose

  3. Disease-free survival rate

    The length of time after surgical resection the patient remains free of recurrence/progression or death, whatever the cause.

    Measured: up to 3 years after surgery

  4. The concordance rate of EGFR mutations between surgical tissue and BAL fluid samples

    The concordance rate of BALF EGFR mutation compared with EGFR mutation status of surgical resected tissue

    Measured: From the day of screening day to an average of 16 weeks after the first dose

Timeline

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

  1. First posted21 Jul 2022
  2. Study start19 May 2022
  3. Primary completion19 May 2024 (estimated)
  4. Study completion19 May 2027 (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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05469022
Sponsor's protocol ID
NeolazBAL
Status last verified
Jul 2022
First submitted
15 Jul 2022
Last updated
21 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhong WZ, Wang Q, Mao WM, Xu ST, Wu L, Shen Y, Liu YY, Chen C, Cheng Y, Xu L, Wang J, Fei K, Li XF, Li J, Huang C, Liu ZD, Xu S, Chen KN, Xu SD, Liu LX, Yu P, Wang BH, Ma HT, Yan HH, Yang XN, Zhou Q, Wu YL; ADJUVANT investigators. Gefitinib versus vinorelbine plus cisplatin as adjuvant treatment for stage II-IIIA (N1-N2) EGFR-mutant NSCLC (ADJUVANT/CTONG1104): a randomised, open-label, phase 3 study. Lancet Oncol. 2018 Jan;19(1):139-148. doi: 10.1016/S1470-2045(17)30729-5. Epub 2017 Nov 21.

    PubMed 29174310

  • Xie H, Wang H, Xu L, Li M, Peng Y, Cai X, Feng Z, Ren W, Peng Z. Gefitinib Versus Adjuvant Chemotherapy in Patients With Stage II-IIIA Non-Small-Cell Lung Cancer Harboring Positive EGFR Mutations: A Single-Center Retrospective Study. Clin Lung Cancer. 2018 Nov;19(6):484-492. doi: 10.1016/j.cllc.2018.05.007. Epub 2018 May 26.

    PubMed 30369426

  • Yue D, Xu S, Wang Q, Li X, Shen Y, Zhao H, Chen C, Mao W, Liu W, Liu J, Zhang L, Ma H, Li Q, Yang Y, Liu Y, Chen H, Wang C. Erlotinib versus vinorelbine plus cisplatin as adjuvant therapy in Chinese patients with stage IIIA EGFR mutation-positive non-small-cell lung cancer (EVAN): a randomised, open-label, phase 2 trial. Lancet Respir Med. 2018 Nov;6(11):863-873. doi: 10.1016/S2213-2600(18)30277-7. Epub 2018 Aug 24.

    PubMed 30150014

  • Liu SY, Zhang JT, Zeng KH, Wu YL. Perioperative targeted therapy for oncogene-driven NSCLC. Lung Cancer. 2022 Oct;172:160-169. doi: 10.1016/j.lungcan.2022.05.007. Epub 2022 May 21.

    PubMed 35644704

  • Pennell NA, Neal JW, Chaft JE, Azzoli CG, Janne PA, Govindan R, Evans TL, Costa DB, Wakelee HA, Heist RS, Shapiro MA, Muzikansky A, Murthy S, Lanuti M, Rusch VW, Kris MG, Sequist LV. SELECT: A Phase II Trial of Adjuvant Erlotinib in Patients With Resected Epidermal Growth Factor Receptor-Mutant Non-Small-Cell Lung Cancer. J Clin Oncol. 2019 Jan 10;37(2):97-104. doi: 10.1200/JCO.18.00131. Epub 2018 Nov 16.

    PubMed 30444685

  • Zhang Y, Fu F, Hu H, Wang S, Li Y, Hu H, Chen H. Gefitinib as neoadjuvant therapy for resectable stage II-IIIA non-small cell lung cancer: A phase II study. J Thorac Cardiovasc Surg. 2021 Feb;161(2):434-442.e2. doi: 10.1016/j.jtcvs.2020.02.131. Epub 2020 Mar 19.

    PubMed 32340810

  • 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.

    PubMed 30158288

  • Zhong W, Yang X, Yan H, Zhang X, Su J, Chen Z, Liao R, Nie Q, Dong S, Zhou Q, Yang J, Tu H, Wu YL. Phase II study of biomarker-guided neoadjuvant treatment strategy for IIIA-N2 non-small cell lung cancer based on epidermal growth factor receptor mutation status. J Hematol Oncol. 2015 May 17;8:54. doi: 10.1186/s13045-015-0151-3.

    PubMed 25981169

  • Zhong WZ, Chen KN, Chen C, Gu CD, Wang J, Yang XN, Mao WM, Wang Q, Qiao GB, Cheng Y, Xu L, Wang CL, Chen MW, Kang X, Yan W, Yan HH, Liao RQ, Yang JJ, Zhang XC, Zhou Q, Wu YL. Erlotinib Versus Gemcitabine Plus Cisplatin as Neoadjuvant Treatment of Stage IIIA-N2 EGFR-Mutant Non-Small-Cell Lung Cancer (EMERGING-CTONG 1103): A Randomized Phase II Study. J Clin Oncol. 2019 Sep 1;37(25):2235-2245. doi: 10.1200/JCO.19.00075. Epub 2019 Jun 13.

    PubMed 31194613

  • Ahn MJ, Han JY, Lee KH, Kim SW, Kim DW, Lee YG, Cho EK, Kim JH, Lee GW, Lee JS, Min YJ, Kim JS, Lee SS, Kim HR, Hong MH, Ahn JS, Sun JM, Kim HT, Lee DH, Kim S, Cho BC. Lazertinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: results from the dose escalation and dose expansion parts of a first-in-human, open-label, multicentre, phase 1-2 study. Lancet Oncol. 2019 Dec;20(12):1681-1690. doi: 10.1016/S1470-2045(19)30504-2. Epub 2019 Oct 3.

    PubMed 31587882

  • Schaake EE, Kappers I, Codrington HE, Valdes Olmos RA, Teertstra HJ, van Pel R, Burgers JA, van Tinteren H, Klomp HM. Tumor response and toxicity of neoadjuvant erlotinib in patients with early-stage non-small-cell lung cancer. J Clin Oncol. 2012 Aug 1;30(22):2731-8. doi: 10.1200/JCO.2011.39.4882. Epub 2012 Jul 2.

    PubMed 22753915

  • Kim IA, Hur JY, Kim HJ, Kim WS, Lee KY. Extracellular Vesicle-Based Bronchoalveolar Lavage Fluid Liquid Biopsy for EGFR Mutation Testing in Advanced Non-Squamous NSCLC. Cancers (Basel). 2022 May 31;14(11):2744. doi: 10.3390/cancers14112744.

    PubMed 35681723

  • Kim IA, Hur JY, Kim HJ, Lee SE, Kim WS, Lee KY. Liquid biopsy using extracellular vesicle-derived DNA in lung adenocarcinoma. J Pathol Transl Med. 2020 Nov;54(6):453-461. doi: 10.4132/jptm.2020.08.13. Epub 2020 Oct 8.

    PubMed 33027851

  • Hur JY, Lee JS, Kim IA, Kim HJ, Kim WS, Lee KY. Extracellular vesicle-based EGFR genotyping in bronchoalveolar lavage fluid from treatment-naive non-small cell lung cancer patients. Transl Lung Cancer Res. 2019 Dec;8(6):1051-1060. doi: 10.21037/tlcr.2019.12.16.

    PubMed 32010582

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neoadjuvant lazertinib in people with Non Small Cell Lung Cancer, run by Konkuk University Medical Center at 1 site 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 12 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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

Contact In Ae Kim, MD. PhD. (+821035438353, 20180618@kuh.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: 9 weeks after the starting day of the lazertinib). 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 NCT05469022, which also lists 14 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 21 Jul 2022.

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