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

Primary Purpose

Plasma EGFR Mutation-positive Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Icotinib

About this trial

This is an interventional treatment trial for Plasma EGFR Mutation-positive Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

National Cancer Center/Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: icotinib

Arm Description

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

Outcomes

Primary Outcome Measures

ORR

Objective Response Rate

Secondary Outcome Measures

PFS

Progression-free survival

DCR

disease control rate

overall survival

Full Information

NCT ID

NCT03346811

First Posted

November 15, 2017

Last Updated

November 15, 2017

Sponsor

Betta Pharmaceuticals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03346811

Brief Title

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

Acronym

CHALLENGE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Unknown status

Study Start Date

November 18, 2017 (Anticipated)

Primary Completion Date

May 10, 2019 (Anticipated)

Study Completion Date

March 10, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Betta Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plasma EGFR Mutation-positive Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental: icotinib

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Icotinib

Other Intervention Name(s)

conmana

Intervention Description

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

Primary Outcome Measure Information:

Title

ORR

Description

Objective Response Rate

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

PFS

Description

Progression-free survival

Time Frame

12 months

Title

DCR

Description

disease control rate

Time Frame

12 months

Title

Description

overall survival

Time Frame

20 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jie Wang, MD

Phone

13910704669

zlhuxi@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhijie Wang, MD

Phone

13466323860

jie_969@163.com

Facility Information:

Facility Name

National Cancer Center/Cancer Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jie Wang, MD

Phone

13910704669

zlhuxi@163.com

First Name & Middle Initial & Last Name & Degree

Zhijie Wang, MD

Phone

13466323860

jie_969@163.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

35862035

Citation

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.

Results Reference

derived

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

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