Plasma EGFR Mutation-positive Lung CancerPhase 2CHALLENGENCT03346811
Efficiency of Icotinib in Plasma ctDNA EGFR Mutation-positive Patients Diagnosed With Lung Cancer
A Phase 2 study testing Icotinib in people with Plasma EGFR Mutation-positive Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasma EGFR Mutation-positive Lung Cancer
- What is being tested?
- Icotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2017to 10 Mar 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
National Cancer Center/Cancer Hospital
Beijing, Beijing Municipality, 100021
Jie Wang, MD, 13910704669, zlhuxi@163.com
Zhijie Wang, MD, 13466323860, jie_969@163.com
About this study
Official title: 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
- Being tested
- Icotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcotinibDrug
Also called conmana
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Icotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate
Measured: 12 weeks
Secondary outcomes (3)
PFS
Progression-free survival
Measured: 12 months
DCR
disease control rate
Measured: 12 months
OS
overall survival
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start18 Nov 2017 (estimated)
- Primary completion10 May 2019 (estimated)
- Study completion10 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plasma EGFR Mutation-positive Lung CancerStudies of the same condition, open and under way.
- More trials run by Betta Pharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346811
- Sponsor's protocol ID
- BD-IC-IV90
- Acronym
- CHALLENGE
- Status last verified
- Nov 2017
- First submitted
- 15 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35862035
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Icotinib in Plasma ctDNA EGFR Mutation-positive Patients Diagnosed With Lung Cancer：a Single Arm，Multi-center，Open-label Study
- ClinicalTrials.gov ID
- NCT03346811
- Acronym / sponsor ID
- CHALLENGE / BD-IC-IV90
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2017 (estimated)
- Primary completion
- 10 May 2019 (estimated)
- Study completion
- 10 Mar 2020 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: icotinib | Experimental | Drug: IcotinibPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IcotinibAlso: conmanaPatients 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 | Experimental: icotinib |
Primary outcome
ORR
Time frame: 12 weeks
Objective Response Rate
3 secondary outcomes
PFS
Time frame: 12 months
DCR
Time frame: 12 months
OS
Time frame: 20 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Derived from this study: PubMed 35862035Xu 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Icotinib in people with Plasma EGFR Mutation-positive Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Wang, MD (13910704669, zlhuxi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03346811, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.