Efficiency of Icotinib in Plasma ctDNA EGFR Mutation-positive Patients Diagnosed With Lung Cancer (CHALLENGE)

Efficiency of Icotinib in Plasma ctDNA EGFR Mutation-positive Patients Diagnosed With Lung Cancer：a Single Arm，Multi-center，Open-label Study

this single arm，open-label，multi-center study is aimed to evaluate the efficiency of icotinib in plasma ctDNA EGFR mutation-positive patients diagnosed with lung cancer

Study Overview

• Status: Unknown
• Conditions: Plasma EGFR Mutation-positive Lung Cancer
• Intervention / Treatment: Drug: Icotinib

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • National Cancer Center/Cancer Hospital
      • Contact: Jie Wang, MD; Phone Number: 13910704669; Email: zlhuxi@163.com
      • Contact: Zhijie Wang, MD; Phone Number: 13466323860; Email: jie_969@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of peripheral lung cancer, but the pathological diagnosis is not yet clear.
• Plasma EGFR mutations (EGFR 19del and/or 21L858R) positive (simultaneously detected by Super-ARMS, ddPCR and NGS，any positive).
• unavailable of radical surgery or radical radiotherapy.
• not previously received anticancer therapy like surgery, chemotherapy, radiation therapy, and biotherapy etc.
• Palliative radiotherapy for bone metastases is permitted, but there is no continuous toxicity associated with radiation therapy.
• Age 18-75 years old with performance status of 0 to 3.
• With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)) according to RECIST Criteria.None of the lesions treated with radiotherapy could be used as target lesions.
• Adequate hematological, biochemical and organ functions.

Exclusion Criteria:

• Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
• Evidence of interstitial lung diseases
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
• Other situations researchers think not appropriate to enter the group

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: icotinib; Patients diagnosed with lung cancer with plasma EGFR mutation-positive are arranged to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity	Drug: Icotinib; Patients with plasma EGFR mutation-positive are arranged to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity; Other Names: conmana

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective Response Rate	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression-free survival	12 months
DCR	disease control rate	12 months
OS	overall survival	20 months

Collaborators and Investigators

• Sponsor: Betta Pharmaceuticals Co., Ltd.

Publications and helpful links

General Publications

• Xu J, Liu Z, Bai H, Dong G, Zhong J, Wan R, Zang A, Li X, Li Q, Guo J, Du N, Zhong D, Huang Y, Lv Q, Zhang J, Zhao Y, Gao L, Li L, Zhang C, Zhao J, Li B, Liu Z, Yang Z, Ji D, Wang T, Duan J, Wang Z, Wang J. Evaluation of Clinical Outcomes of Icotinib in Patients With Clinically Diagnosed Advanced Lung Cancer With EGFR-Sensitizing Variants Assessed by Circulating Tumor DNA Testing: A Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. 2022 Sep 1;8(9):1328-1332. doi: 10.1001/jamaoncol.2022.2719.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 18, 2017
• Primary Completion (Anticipated): May 10, 2019
• Study Completion (Anticipated): March 10, 2020

Study Registration Dates

• First Submitted: November 15, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 15, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: BD-IC-IV90

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No