NCT04415853

Lerotinib Versus Investigator's Choice Single-agent Chemotherapy in Patients With Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma and EGFR Overexpression That Progressed After Second-line Therapy:Phase 3 Study

Recruiting now Phase 3 Last updated 16 May 2025

What this trial tests

Phase 3 trial testing Lerotinib in Esophageal Cancer in 416 participants. Currently enrolling.

Timeline

21 January 2021

Primary endpoint
1 August 2026

30 December 2026

Quick facts

Lead sponsor	Sunshine Lake Pharma Co., Ltd.
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	416
Start date	21 January 2021
Primary completion	1 August 2026
Estimated completion	30 December 2026
Sites	1 location across China

Drugs / interventions tested

• Lerotinib — full drug profile →
• Irinotecan/Tegafur — full drug profile →

Conditions studied

• Esophageal Cancer — all drugs for Esophageal Cancer →

Sponsor

Sunshine Lake Pharma Co., Ltd. — full company profile →

Who can join

Adults 18 to 80, any sex, with Esophageal Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Overall survival
  Time frame: up to approximately 22 months
  Defined as time from date of randomization to date of death due to any cause. OS was calculated using product-limit (Kaplan-Meier) method for censored data.

Sponsor's own description

This is a randomized, controlled, multi-center, open trial, unresectable locally advanced or metastatic esophageal squamous cell carcinoma patients that failed at least second-line treatment and overexpressed EGFR were enrolled and randomly assigned to the experimental group and control group at a 1: 1 ratio.,who received Larotinib and the chemotherapy regimen chosen by the investigator (Irinotecan Hydrochloride Injection or Tegafur Gimeracil Oteracil Potassium Capsule),respecitively.

Subjects are administered until disease progression assessed by the RECIST V1.1 standard (unless the investigator evaluates that the subject continues to have clinical benefit from continuing treatment, the subject may be allowed to continue treatment), and begins to receive new anti-tumor treatment, unacceptable toxicity, withdrawal of informed consent, or other conditions that meet the criteria for terminating trial treatment / withdrawal from the trial.

The research phase of this study is divided into pre-screening period (\~ D-28), screening period (D-28 \~ D-1), treatment period, treatment end visit (± 7 days after the last dose), safety follow-up ( Until 28 ± 7 days after the last dose) and survival follow-up.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Structural Insight and Development of EGFR Tyrosine Kinase Inhibitors.
   Amelia T, Kartasasmita RE, Ohwada T, Tjahjono DH. · · 2022 · cited 83× · PMID 35164092 · DOI 10.3390/molecules27030819
2. Potent molecular-targeted therapies for advanced esophageal squamous cell carcinoma.
   Ooki A, Osumi H, Chin K, Watanabe M, et al · · 2023 · cited 17× · PMID 36872946 · DOI 10.1177/17588359221138377
3. Larotinib in patients with advanced and previously treated esophageal squamous cell carcinoma with epidermal growth factor receptor overexpression or amplification: an open-label, multicenter phase 1b study.
   Liu R, Liu L, Zhao C, Bai Y, et al · · 2021 · cited 6× · PMID 34688250 · DOI 10.1186/s12876-021-01982-4
4. Prognostic Biomarkers and Immunotherapeutic Insights of Circulating Tumor DNA Analysis in Advanced Esophageal Squamous Cell Carcinoma From SCRUM-MONSTAR GOZILA Substudy.
   Duan Y, Hashimoto T, Shibuki T, Taniguchi H, et al · · 2026 · PMID 41911515 · DOI 10.1200/po-25-00971
5. Changing landscape of advanced esophageal squamous cell carcinoma: Breakthroughs in systemic therapies (Review).
   Li Y, Li J, Mo W, Xu X. · · 2025 · PMID 40682837 · DOI 10.3892/or.2025.8953