EGFR Positive Non-Small Cell Lung Cancer,AdenocarcinomaPhase 2NCT03402464
Icotinib Combined With Dihydroaremisinin (DHA) Therapy in Patients With Advanced NSCLC
A Phase 2 study testing Icotinib combined dihydroaremisinin in people with EGFR Positive Non-Small Cell Lung Cancer,Adenocarcinoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
The study was to evaluate the safety, PFS and ORR of icotinib/dihydroaremisinin (DHA)-based combination therapy in EGFR-mutated, advanced NSCLC patients who have gradually progressed disease after first-line icotinib treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR Positive Non-Small Cell Lung Cancer,Adenocarcinoma
- What is being tested?
- Icotinib combined dihydroaremisinin
- 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
- Jan 2018to 20 Sep 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
- Patients confirmed with stage IV lung adenocarcinoma by pathologic histology or cytology who can't accept surgery and radiotherapy
- Male or female patients aged ≥18 years, life expectancy ≥ 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Sensitive EGFR gene mutation(19/21)
- Failed with first-line icotinib and have gradually progressed disease More than 6-month duration of first-line icotinib (from the first dosing to the imaging-confirmed progression; and discontinuation of icotinib is less than 14 days) No significantly increased tumor size compared with the final imaging evaluation
Who cannot join
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease)
- Female subjects should not be pregnant or breast-feeding
- Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
- Previous systemic anti-tumor therapy except for icotinib , including chemotherapy or targeted therapy ( including but not limited to monoclonal or antibodies, small molecule tyrosine kinase inhibitor, etc)
- Tumor metastasis of the spinal cord, meninges or meningeal neoplasms confirmed by imaging or cerebrospinal fluid examination
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Cancer Hospital
Beijing, 100142
Ziping Wang, MD, 86-10-88121122, wangzp2007@126.com
Ziping Wang, MD
About this study
Official title: Icotinib Combined With Dihydroaremisinin (DHA) Therapy in Patients With Advanced Gradually Progressed NSCLC After First-line Icotinib: an Open-label, Single-arm, Multicenter Phase II Study
The study was to evaluate the safety, PFS and ORR of icotinib/dihydroaremisinin (DHA)-based combination therapy in EGFR-mutated, advanced NSCLC patients who have gradually progressed disease after first-line icotinib treatment.
- Being tested
- Icotinib combined dihydroaremisinin
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icotinib combined dihydroaremisininDrug
Icotinib should be taken by the patients continuously until disease progressed or intolerable toxicity. On day 1-3, oral dihydroaremisinin was given at 20mg per day, the dose of dihydroaremisinin is increased to 40mg daily on day 4 to 6, and 80mg twice daily until disease progressed or intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Icotinib combined dihydroaremisinin | Experimental | Not described Receives: Drug: Icotinib combined dihydroaremisinin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress Free Survival
Measured: 18 months
Objective response rate
Measured: 18 months
Secondary outcomes (1)
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 posted18 Jan 2018
- Study startJan 2018 (estimated)
- Primary completion1 Jun 2019 (estimated)
- Study completion20 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Positive Non-Small Cell Lung Cancer,AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Betta Pharmaceuticals Co., Ltd.
- Responsible party
- Principal investigator, Ziping Wang, Peking University Cancer Hospital & Institute
- Investigators
- Ziping Wang, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402464
- Sponsor's protocol ID
- BD-IC-IV88
- Status last verified
- Jan 2018
- First submitted
- 11 Jan 2018
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Icotinib Combined With Dihydroaremisinin (DHA) Therapy in Patients With Advanced Gradually Progressed NSCLC After First-line Icotinib: an Open-label, Single-arm, Multicenter Phase II Study
- ClinicalTrials.gov ID
- NCT03402464
- Acronym / sponsor ID
- BD-IC-IV88
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Betta Pharmaceuticals Co., Ltd.
- Study start
- Jan 2018 (estimated)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 20 Sep 2020 (estimated)
- First posted
- 18 Jan 2018 (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.
The study was to evaluate the safety, PFS and ORR of icotinib/dihydroaremisinin (DHA)-based combination therapy in EGFR-mutated, advanced NSCLC patients who have gradually progressed disease after first-line icotinib treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Icotinib combined dihydroaremisinin | Experimental | Drug: Icotinib combined dihydroaremisinin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients confirmed with stage IV lung adenocarcinoma by pathologic histology or cytology who can't accept surgery and radiotherapy
- Male or female patients aged ≥18 years, life expectancy ≥ 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Sensitive EGFR gene mutation(19/21)
- Failed with first-line icotinib and have gradually progressed disease More than 6-month duration of first-line icotinib (from the first dosing to the imaging-confirmed progression; and discontinuation of icotinib is less than 14 days) No significantly increased tumor size compared with the final imaging evaluation
Key exclusion criteria (5 listed)
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease)
- Female subjects should not be pregnant or breast-feeding
- Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
- Previous systemic anti-tumor therapy except for icotinib , including chemotherapy or targeted therapy ( including but not limited to monoclonal or antibodies, small molecule tyrosine kinase inhibitor, etc)
- Tumor metastasis of the spinal cord, meninges or meningeal neoplasms confirmed by imaging or cerebrospinal fluid examination
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 |
|---|---|---|
| Icotinib combined dihydroaremisininIcotinib should be taken by the patients continuously until disease progressed or intolerable toxicity. On day 1-3, oral dihydroaremisinin was given at 20mg per day, the dose of dihydroaremisinin is increased to 40mg daily on day 4 to 6, and 80mg twice daily until disease progressed or intolerable toxicity. | Drug | Icotinib combined dihydroaremisinin |
Primary outcome
Progress Free Survival
Time frame: 18 months
Objective response rate
Time frame: 18 months
1 secondary outcome
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 18 Jan 2018.
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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.
Ziping Wang, MD principal investigator
Peking University Cancer Hospital & Institute
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 combined dihydroaremisinin in people with EGFR Positive Non-Small Cell Lung Cancer,Adenocarcinoma, run by Peking University Cancer Hospital & Institute 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 5 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 18 Jan 2018. 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 Ziping Wang, MD (86-10-88121122, wangzp2007@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress Free Survival (time frame: 18 months). The study lists 2 primary outcomes in all. 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 18 Jan 2018.