Phase III Trial to Evaluate the Elortinib vs Gefitinib in Advanced NSCLC With EGFR Exon 19 or 21 Mutations

Conditions

Thoracic Neoplasms

Keywords

Thoracic Neoplasms, Molecular Mechanisms of Pharmacological Action, Protein Kinase Inhibitors, Respiratory Tract Diseases, Lung Neoplasms, Erlotinib, Gefitinib, Epidermal growth factor receptor genes

Brief summary

This is a randomized controlled trial to compare efficacy and safety between erlotinib and gefitinib in advanced NSCLC harboring EGFR exon 19 or 21 mutations.Eligible patients were randomized to receive erlotinib or gefitinib in any line settings.The primary endpoint was progression-free survival (PFS).

Detailed description

Patients with stage IV NSCLC who have EGFR exon 19 or 21 mutations will randomized to received oral erlotinib 150mg or gefitinib 250mg once daily until disease progression or unacceptable toxicity. Method of direct DNA sequencing of tumor tissue is used to analysis EGFR mutation status of exons 18-21. The response will be evaluated by RECIST criteria first month,second month and then repeat every 3 months after the beginning of the treatment weeks.

Yongfeng Yu, Luan Luan, Fanfan Zhu, Peng Dong, Liheng Ma et al. (8 authors)

Frontiers in Oncology2021-12-147 citations

10.3389/fonc.2021.564234

Association of allele frequency of <i>EGFR</i> mutation with efficacy of <i>EGFR</i> TKIs in advanced non-small cell lung cancer.

Xiang-Meng Li, Jin‐Ji Yang, Yi‐Long Wu

Journal of Clinical Oncology2019-05-203 citations

10.1200/jco.2019.37.15_suppl.e20678

Development of genetic profiles-based nomograms for predicting survival among EGFR-mutant lung cancer.

Ruilian Chen, Hai‐Yan Tu, Hua‐Jun Chen, Qing Zhou, Yi‐Long Wu et al. (12 authors)

Journal of Clinical Oncology2018-05-20

10.1200/jco.2018.36.15_suppl.e21219

Serial cfDNA assessment of response and resistance to EGFR-TKI for patients with EGFR-L858R mutant lung cancer from a prospective clinical trial.

Zhou Q, Yang JJ, Chen ZH, Zhang XC, Yan HH, Xu CR, Su J, Chen HJ, Tu HY, Zhong WZ, Yang XN, Wu YL.

2016-09-1339 citations

10.1186/s13045-016-0316-8

Interventions

DRUGerlotinib

study arm.erlotinib 150 mg oral till disease progression

DRUGgefitinib

study arm.gefitinib 250 mg oral till disease progression

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

Inclusion criteria

* Histologically or cytologically confirmed stage IIIB (wet) or IV NSCLC. * Patients with positive EGFR exon19 or exon21 mutation as confirmed by direct sequencing histologically. * Signing the informed consent form. * The vital organ functions are tolerant to therapy. * Have recovered to CTCAE2 grade below from toxicity of previous chemotherapy and radiotherapy * PS 0-2 scores. * Functional reserve of bone marrow is adequate, e.g. white blood cell count ≥3.0×109/L, planet count ≥90×109/L, and HB≥80×109/L. * Serum bilirubin is 2 times less than the upper limit of normal (ULN), ALT and AST are 3 times less than ULN; for liver metastases, ALT and AST need to be 5 times less than ULN; creatinine should be 2 times less than ULN.

Exclusion criteria

* Informed consent is not provided. * Women of pregnancy or breastfeeding. * Have difficulty in swallowing.

Design outcomes

Primary

Measure	Time frame
progression-free survival	two years

Secondary

Measure	Time frame
overall survival	three years
Safety events	two years
Pharmacoeconomic	two years
Response rate	one year

Countries

China

Outcome results

None listed