EGFR Positive Non-small Cell Lung CancerPhase 4NCT01665417
Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma
A Phase 4 study testing Experimental and Chemotherapy in people with EGFR Positive Non-small Cell Lung Cancer and Adenocarcinoma, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance treatment with icotinib. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- EGFR Positive Non-small Cell Lung Cancer, Adenocarcinoma
- What is being tested?
- Experimental and Chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Aug 2012to Dec 2017
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT); Patients must have previously untreated locally advanced or metastatic NSCLC; Patients must have lung cancer with a documented EGFR activating mutation (exon 19 deletion, L858R).
Who cannot join
- Prior chemotherapy Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR Patients must not be receiving any other investigational agents Any evidence of interstitial lung disease
Trial locations and contacts
1 site in 1 country.
Jiao Shunchang, MD contact
China1 site, 1 recruiting
- Recruiting
Chinese People's Liberation Army (PLA) General Hospital
Beijing, Beijing Municipality, 100853
Jiao Shunchang, MD, 0086-13801380677
Jiao Shunchang, MD
About this study
Official title: Randomized, Open Label, Positive Controlled, Multicenter Trial to Evaluate Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma
This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance treatment with icotinib.
Read the detailed description
This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib.
Primary endpoint:
Progression-free survival between first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib
Secondary endpoint:
- Overall survival between icotinib and chemotherapy
- Time to Progression between icotinib and chemotherapy
- Objective response rate and disease control rate between icotinib and chemotherapy
- Being tested
- Experimental, Chemotherapy
- Keywords
- Icotinib, EGFR positive mutation, First-line treatment, Maintenance treatment
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalDrug
Also called BPI-2009, Commana
Icotinib: 125mg, oral administration, three times per day.
ChemotherapyDrug
Also called Pemetrexe, ALIMTA
Chemotherapy Regimen 1：Pemetrexe 500 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.
ChemotherapyDrug
Also called Docetaxel, Taxotere
Chemotherapy Regimen 2：Docetaxel 75 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Icotinib | Experimental | Icotinib: 125mg, oral administration, three times per day. Receives: Drug: Experimental |
| Chemotherapy Regimen 1 | Active comparator | Chemotherapy Regimen 1：Pemetrexe 500 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity. Receives: Drug: Chemotherapy |
| Chemotherapy Regimen 2 | Active comparator | Chemotherapy Regimen 2：Docetaxel 75 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.
Measured: 8 months
Secondary outcomes (4)
Overall survival
OS was assessed via calculation of the time to death due to any cause from the date of randomization. A patient was censored at the last date they were known to be alive.
Measured: 24 months
Time to Tumor Progression
TTP was defined as the time from the date of first dose of study medication to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.
Measured: 8 months
Objective response rate
Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors(RECIST)1.1.
Measured: 3 months
Number of participants with adverse events
Adverse events assessed by CTCAE4.0.
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 posted15 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiao Shunchang, MD, Principal investigator, Chinese People's Liberation Army (PLA) General HospitalFang Jian, MD, Study director, Peking University Cancer Hospital & InstituteBai Chunmei, MD, Study director, Peking Union Medical College HospitalLiu Wei, MD, Study director, Hebei Provincal Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665417
- Sponsor's protocol ID
- BD-IC-IV08
- Status last verified
- Feb 2017
- First submitted
- 12 Aug 2012
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open Label, Positive Controlled, Multicenter Trial to Evaluate Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01665417
- Acronym / sponsor ID
- BD-IC-IV08
- Keywords
- Icotinib, EGFR positive mutation, First-line treatment, Maintenance treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Aug 2012 (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 is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance treatment with icotinib.
Detailed description
This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib.
Primary endpoint:
Progression-free survival between first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib
Secondary endpoint:
- Overall survival between icotinib and chemotherapy
- Time to Progression between icotinib and chemotherapy
- Objective response rate and disease control rate between icotinib and chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Icotinib | Experimental | Drug: ExperimentalIcotinib: 125mg, oral administration, three times per day. |
| Chemotherapy Regimen 1 | Active comparator | Drug: ChemotherapyChemotherapy Regimen 1：Pemetrexe 500 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity. |
| Chemotherapy Regimen 2 | Active comparator | Drug: ChemotherapyChemotherapy Regimen 2：Docetaxel 75 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT); Patients must have previously untreated locally advanced or metastatic NSCLC; Patients must have lung cancer with a documented EGFR activating mutation (exon 19 deletion, L858R).
Key exclusion criteria (1 listed)
- Prior chemotherapy Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR Patients must not be receiving any other investigational agents Any evidence 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 |
|---|---|---|
| ExperimentalAlso: BPI-2009, CommanaIcotinib: 125mg, oral administration, three times per day. | Drug | Experimental Icotinib |
| ChemotherapyAlso: Pemetrexe, ALIMTAChemotherapy Regimen 1：Pemetrexe 500 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity. | Drug | Chemotherapy Regimen 1, Chemotherapy Regimen 2 |
| ChemotherapyAlso: Docetaxel, TaxotereChemotherapy Regimen 2：Docetaxel 75 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity. | Drug | Chemotherapy Regimen 1, Chemotherapy Regimen 2 |
Primary outcome
Progression-free survival
Time frame: 8 months
PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.
4 secondary outcomes
Overall survival
Time frame: 24 months
Time to Tumor Progression
Time frame: 8 months
Objective response rate
Time frame: 3 months
Number of participants with adverse events
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 8 Feb 2017.
Related trials for EGFR Positive Non-small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruitingPhase 1
Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC
EGFR-mutant Non-small Cell Lung Cancer
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
Active, not recruitingPhase 2
Osimertinib Plus Savolitinib in EGFRm+/MET+ NSCLC Following Prior Osimertinib
Carcinoma
Not yet recruitingPhase 4
A Clinical Study Comparing the Efficacy and Safety of Befotertinib Versus Icotinib in Patients With Previously Untreated EGFR-sensitive Mutation-positive Non-small Cell Lung Cancer With ECOG Score ≥2
Locally Advanced or Metastatic Non-small Cell Lung Cancer With Previously Untreated EGFR-sensitive Mutations and ECOG Performance Status Score ≥2
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.
Jiao Shunchang, MD contact
Jiao Shunchang, MD principal investigator
Chinese People's Liberation Army (PLA) General Hospital
Fang Jian, MD study director
Peking University Cancer Hospital & Institute
Bai Chunmei, MD study director
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Experimental and Chemotherapy in people with EGFR Positive Non-small Cell Lung Cancer and Adenocarcinoma, 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 1 inclusion and 1 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 8 Feb 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Jiao Shunchang, MD (0086-13801380677), 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: 8 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 8 Feb 2017.