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

NCT03346811 | Unknown Phase 2

• 1 other identifier: BD-IC-IV90
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Plasma EGFR Mutation-positive Lung Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate

  12 weeks

Secondary Outcomes (3)

• PFS

  12 months

• DCR

  12 months

• OS

  20 months

Study Arms (1)

Experimental: icotinib

EXPERIMENTAL

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

Interventions

Icotinib DRUG

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

Also known as: conmana

Experimental: icotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

National Cancer Center/Cancer Hospital

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35862035 DERIVED

MeSH Terms

Interventions

icotinib

Central Study Contacts

Jie Wang, MD

CONTACT

13910704669; zlhuxi@163.com

Zhijie Wang, MD

CONTACT

13466323860; jie_969@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 17, 2017
• Study Start: November 18, 2017
• Primary Completion: May 10, 2019
• Study Completion: March 10, 2020
• Last Updated: November 17, 2017

Record last verified: 2017-11

Locations

CN (1)