Evidence map›Paper›PMID 39379931›Full record

Trial reportBMC medicine2024

Updated overall survival and ctDNA analysis in patients with EGFR T790M-positive advanced non-small cell lung cancer treated with lazertinib in the phase 1/2 LASER201 study.

Ji-Youn Han, Myung-Ju Ahn, Ki Hyeong Lee, Yun-Gyoo Lee, Dong-Wan Kim, Young Joo Min, Sang-We Kim, Eun Kyung Cho, Joo-Hang Kim, Gyeong-Won Lee and 7 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in BMC medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03046992 (A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of YH25448 in Patients with EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03046992 phase1 / phase2completednot on this map

A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of YH25448 in Patients with EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)

TypeinterventionalSponsorYuhan CorporationRan2017 to 2023Enrolled224ConditionsEGFR Gene MutationArmsYH25448
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Article
  6. Review
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Ji-Youn HanDivision of Hemato-Oncology, Center for Lung Cancer, Research Institute and Hospital, National Cancer Center, Gyeonggi-Do, Republic of Korea. jymama@ncc.re.kr.ORCID 0000-0001-5033-0006
Myung-Ju AhnDepartment of Hematology and Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Ki Hyeong LeeDivision of Medical Oncology, Department of Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea.
Yun-Gyoo LeeDepartment of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Dong-Wan KimDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Young Joo MinDivision of Hematology and Oncology, Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Republic of Korea.
Sang-We KimDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Ulsan, Republic of Korea.
Eun Kyung ChoDivision of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.
Joo-Hang KimDivision of Hematology-Oncology, Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Gyeonggi-Do, Republic of Korea.
Gyeong-Won LeeDivision of Hematology and Oncology, Department of Internal Medicine, Gyeongsang National University Hospital, Gyeongsang National University College of Medicine, Gyeongsangnam-Do, Republic of Korea.
Sung Sook LeeDepartment of Hematology-Oncology, Inje University Haeundae Paik Hospital, Inje University College of Medicine, Busan, Republic of Korea.
Na Mi LeeClinical Development and Medical Division, Yuhan Corporation, Seoul, Republic of Korea.
Hyun Woo JangClinical Development and Medical Division, Yuhan Corporation, Seoul, Republic of Korea.
Heewon HanClinical Development and Medical Division, Yuhan Corporation, Seoul, Republic of Korea.
Hyejoo ParkClinical Development and Medical Division, Yuhan Corporation, Seoul, Republic of Korea.
Jieon LeeClinical Development and Medical Division, Yuhan Corporation, Seoul, Republic of Korea.
Byoung Chul ChoDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLazertinib is a potent, irreversible, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with significant efficacy in patients with EGFR T790M-mutated non-small cell lung cancer (NSCLC). This is the final overall survival (OS) report from the phase 1/2 LASER201 study in patients with advanced NSCLC with disease progression on or after prior EGFR TKI therapy.

methodsEligible patients were aged ≥ 20 years, with advanced EGFR-mutated NSCLC and previous therapy with EGFR TKI. Patients in this integrated analysis received oral lazertinib 240 mg/day. Endpoints included efficacy and safety; exploratory analyses included associations between circulating EGFR-mutant tumor DNA (ctDNA) and efficacy parameters.

resultsThis integrated analysis included 78 patients in Korea who received second- or later-line lazertinib. The median OS was 38.9 months; estimated survival rates at 12, 24, and 36 months were 89.5%, 73.9%, and 52.8%, respectively. The cumulative 12-month incidence of central nervous system progression was 9.4%. EGFR-mutant ctDNA was detected in 46 patients (62.2%) at baseline. The presence of ctDNA at baseline significantly predicted progression-free survival (PFS), disease control rate (DCR), and OS. PFS, response rate, and DCR were significantly associated with EGFR-mutant ctDNA clearance at cycle 3; PFS and OS were significantly associated with ctDNA clearance at cycle 5. The safety profile of lazertinib 240 mg/day was consistent with previous findings.

conclusionsLazertinib is a promising treatment option for patients with EGFR T790M-positive NSCLC following disease progression on prior EGFR-directed TKIs. Patients in LASER201 experienced prolonged OS, regardless of their EGFR mutation, brain metastases, or prior brain radiation status. Clearance of plasma EGFR mutations after lazertinib was associated with patient outcomes.

trial registrationClinicalTrials.gov identifier NCT03046992.

Indexed as

Carcinoma, Non-Small-Cell LungErbB ReceptorsLung NeoplasmsAdultAgedAged, 80 and overCirculating Tumor DNAFemaleHumansMaleMiddle AgedMutationProtein Kinase InhibitorsCirculating Tumor DNAEGFR protein, humanErbB ReceptorsProtein Kinase InhibitorsctDNALazertinibNSCLCOverall survivalTKI

Identifiers

PMID39379931
PMCPMC11462748

What Socratic holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.