Non-small Cell Lung CancerPhase 2NCT02961270
Icotinib in Non-small Cell Lung Cancer Patients With Uncommon EGFR Mutation
A Phase 2 study testing Icotinib in people with Non-small Cell Lung Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study aims to evaluate the efficacy of icotinib, a first generation EGFR TKI, in non-small cell lung cancer patients harboring uncommon EGFR mutation Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Icotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Aug 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stage IIIB/IV non-small cell lung cancer
- Patients with uncommon epidermal growth factor receptor (EGFR) mutation
- Targeted-therapy-naive patients
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Evaluable target lesions according to RECIST 1.1 for tumour response assessment
Who cannot join
- Wild-type EGFR
- Positive 19 del and/or 21 L858R mutation
- Previous treatment with EGFR TKIs such as gefitinib, erlotinib, and afatinib
- Patients who have documented history of interstitial lung disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs
Beijing, 100021
Shengyu Zhou, MD, typhoonwho@126.com
About this study
Official title: Clinical Activity of Icotinib in Patients With Advanced Non-small-cell Lung Cancer Harbouring Uncommon EGFR Mutations: a Single-arm, Prospective, Phase 2 Study
This study aims to evaluate the efficacy of icotinib, a first generation EGFR TKI, in non-small cell lung cancer patients harboring uncommon EGFR mutation
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Icotinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcotinibDrug
Icotinib will be given orally 250 mg thrice per day until disease progression, or untolerated toxicity
| Study group | Role | What they receive |
|---|---|---|
| icotinib | Experimental | patients will be administered study drug (icotinib) until disease progression or unacceptable toxicity Receives: Drug: Icotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: 10 months
Secondary outcomes (2)
tumor response rate
Measured: 2 months
overall survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2017 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengyu Zhou, Chinese Academy of Medical Sciences
- Investigators
- Shengyu Zhou, MD, Study chair, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961270
- Sponsor's protocol ID
- CAMS-ZH-001
- Status last verified
- Nov 2016
- First submitted
- 6 Nov 2016
- Last updated
- 11 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Activity of Icotinib in Patients With Advanced Non-small-cell Lung Cancer Harbouring Uncommon EGFR Mutations: a Single-arm, Prospective, Phase 2 Study
- ClinicalTrials.gov ID
- NCT02961270
- Acronym / sponsor ID
- CAMS-ZH-001
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 10 Nov 2016 (estimated)
- 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 study aims to evaluate the efficacy of icotinib, a first generation EGFR TKI, in non-small cell lung cancer patients harboring uncommon EGFR mutation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| icotinib | Experimental | Drug: Icotinibpatients will be administered study drug (icotinib) until disease progression or unacceptable toxicity |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with stage IIIB/IV non-small cell lung cancer
- Patients with uncommon epidermal growth factor receptor (EGFR) mutation
- Targeted-therapy-naive patients
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Evaluable target lesions according to RECIST 1.1 for tumour response assessment
Key exclusion criteria (4 listed)
- Wild-type EGFR
- Positive 19 del and/or 21 L858R mutation
- Previous treatment with EGFR TKIs such as gefitinib, erlotinib, and afatinib
- Patients who have documented history of interstitial lung disease
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 |
|---|---|---|
| IcotinibIcotinib will be given orally 250 mg thrice per day until disease progression, or untolerated toxicity | Drug | icotinib |
Primary outcome
progression-free survival
Time frame: 10 months
2 secondary outcomes
tumor response rate
Time frame: 2 months
overall survival
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
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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.
Shengyu Zhou, MD study chair
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs
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 Non-small Cell Lung Cancer, run by Chinese Academy of Medical Sciences 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 5 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 11 Nov 2016. 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 Shenyu Zhou, MD (86 13520852899, typhoonwho@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Nov 2016.