MedDataX Logo

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

NCT ID: NCT03346811

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-18

Study Completion Date

2020-03-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Plasma EGFR Mutation-positive Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Icotinib

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

conmana

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Betta Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Cancer Center/Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jie Wang, MD

Role: CONTACT

Phone: 13910704669

Email: [email protected]

Zhijie Wang, MD

Role: CONTACT

Phone: 13466323860

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jie Wang, MD

Role: primary

Zhijie Wang, MD

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35862035 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BD-IC-IV90

Identifier Type: -

Identifier Source: org_study_id