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

Sponsor

Betta Pharmaceuticals Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03346811

Collaborator

(none)

120

Enrollment

Location

Arm

27.7

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Plasma EGFR Mutation-positive Lung Cancer	Drug: Icotinib	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 18, 2017

Anticipated Primary Completion Date :

May 10, 2019

Anticipated Study Completion Date :

Mar 10, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

ORR [12 weeks]
Objective Response Rate

Secondary Outcome Measures

PFS [12 months]
Progression-free survival
DCR [12 months]
disease control rate
OS [20 months]
overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Center/Cancer Hospital	Beijing	Beijing	China	100021

Sponsors and Collaborators

Betta Pharmaceuticals Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Betta Pharmaceuticals Co., Ltd.

ClinicalTrials.gov Identifier:

NCT03346811

Other Study ID Numbers:

BD-IC-IV90

First Posted:

Nov 17, 2017

Last Update Posted:

Nov 17, 2017

Last Verified:

Nov 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Neoplasms

Study Results

No Results Posted as of Nov 17, 2017