Non-small Cell Lung CancerPhase 2NCT02407366
Icotinib With Concurrent Radiotherapy vs. Chemoradiotherapy in Non-small Cell Lung Cancer
A Phase 2 study testing Icotinib, Pemetrexed and Carboplatin in people with Non-small Cell Lung Cancer, run by People's Hospital of Guangxi Zhuang Autonomous Region at 1 site in China.
Trial summary
The current standard of care for unresectable locally advanced non-small-cell lung cancer (NSCLC) is a combination of chemotherapy and thoracic radiotherapy (TRT). The standard regimens consist of platinum-based doublet chemotherapy.Icotinib(BPI-2009, Conmana) is the first self-developed small molecular drug in China… 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, Pemetrexed and Carboplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Dec 2017
- 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
- Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation.
- No previous systemic anticancer therapy.
- life expectancy more than three months.
- ECOG Performance Status of 0 to 1.
- Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
- Patients will be required to provide informed consent before enrollment.
Who cannot join
- Intrapulmonary metastasis, atelectasis of an entire hemithorax,pleural dissemination, or contralateral hilar lymph node metastasis.
- Prior chemotherapy for NSCLC, chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway.
- Severe heart disease, uncontrolled diabetes mellitus, or active infection.
- Active concomitant malignancy, and pregnancy or breast-feeding.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The people's Hospital of the Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021
GuoSheng Feng, professor, +86-771-218-6508, fengguosheng88988@163.com
About this study
Official title: A Phase 2 Study of Icotinib With Concurrent Radiotherapy vs. Pemetrexed+ Carboplatin With Concurrent Radiotherapy in Unresectable Stage III Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor ( EGFR) Mutation
The current standard of care for unresectable locally advanced non-small-cell lung cancer (NSCLC) is a combination of chemotherapy and thoracic radiotherapy (TRT). The standard regimens consist of platinum-based doublet chemotherapy.Icotinib(BPI-2009, Conmana) is the first self-developed small molecular drug in China for targeted therapy of lung cancer.Icotinib is a novel oral quinazoline compound that has proven survival benefit in Chinese patients with lung cancer,especially in EGFR mutation lung cancer. This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus pemetrexed + carboplatin with concurrent radiotherapy in inoperable stage III non-small cell lung cancer with EGFR mutation, the primary endpoint is progression-free survival.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Icotinib, Pemetrexed, Carboplatin, Thoracic radiotherapy(TRT)
- Keywords
- Inoperable stage III non-small cell lung cancer, EGFR mutation, Icotinib, Radiotherapy, Chemoradiotherapy
- 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
Also called BPI-2009, Conmana
Icotinib (125 mg ,Three times daily)
PemetrexedDrug
Also called Alimta, LY231514, MTA, Multitargeted Antifolate
Pemetrexed(500mg/m2)every 21 days
CarboplatinDrug
Also called Paraplatin
Carboplatin (AUC，5) every 21 days
Thoracic radiotherapy(TRT)Radiation
TRT (total dose 66Gy, 2Gy per time, once a day, five times a week, a total of 33 times)
| Study group | Role | What they receive |
|---|---|---|
| Icotinib with concurrent radiotherapy | Experimental | Icotinib (125 mg ,three times daily)with concurrent thoracic radiotherapy(TRT) (66 Gy/33 fractions), followed by maintenance icotinib (125 mg ,Three times daily) until disease progression or unacceptable toxicity. Receives: Drug: Icotinib; Radiation: Thoracic radiotherapy(TRT) |
| Chemoradiotherapy | Active comparator | Pemetrexed(500mg/m2) + carboplatin (AUC，5) every 21 days for three cycles with concurrent thoracic radiotherapy(TRT) (66 Gy/33 fractions), followed by consolidation chemotherapy with two cycles of pemetrexed(500mg/m2) + carboplatin (AUC，5) every 21 days.Maintenance pemetrexed(500mg/m2) will be administered after consolidation chemotherapy until disease progression or unacceptable toxicity . Receives: Drug: Pemetrexed; Drug: Carboplatin; Radiation: Thoracic radiotherapy(TRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.
Measured: One year
Secondary outcomes (4)
Overall survival(OS)
Overall survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive.
Measured: two years
Adverse events
The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.
Measured: two years
Objective response rate
Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Measured: two years
Quality of life
Quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) questionnaire.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2016 (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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- People's Hospital of Guangxi Zhuang Autonomous Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guosheng Feng, People's Hospital of Guangxi Zhuang Autonomous Region
- Investigators
- GuoSheng Feng, MD, Study chair, The People's hospital of Guangxi Zhuang AutonomousYuan Liang, MD, Study chair, Guangxi Department of Public HealthLin Hui, MD, Study chair, The People's hospital of Guangxi Zhuang AutonomousHeMing Lu, MD, Study chair, The People's hospital of Guangxi Zhuang AutonomousChangJie Huang, MD, Study chair, Nanning Second People's HospitalGuiSheng LI, MD, Study chair, Liuzhou Workers' HospitalHaiXin Huang, MD, Study chair, Liuzhou Workers' HospitalHaoLin Yan, MD, Study chair, First People's Hospital of Yulin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407366
- Sponsor's protocol ID
- FGSLC-2015
- Status last verified
- Mar 2015
- First submitted
- 25 Mar 2015
- Last updated
- 2 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Icotinib With Concurrent Radiotherapy vs. Pemetrexed+ Carboplatin With Concurrent Radiotherapy in Unresectable Stage III Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor ( EGFR) Mutation
- ClinicalTrials.gov ID
- NCT02407366
- Acronym / sponsor ID
- FGSLC-2015
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Inoperable stage III non-small cell lung cancer, EGFR mutation, Icotinib, Radiotherapy, Chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- People's Hospital of Guangxi Zhuang Autonomous RegionUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 Apr 2015 (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.
The current standard of care for unresectable locally advanced non-small-cell lung cancer (NSCLC) is a combination of chemotherapy and thoracic radiotherapy (TRT). The standard regimens consist of platinum-based doublet chemotherapy.Icotinib(BPI-2009, Conmana) is the first self-developed small molecular drug in China for targeted therapy of lung cancer.Icotinib is a novel oral quinazoline compound that has proven survival benefit in Chinese patients with lung cancer,especially in EGFR mutation lung cancer. This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus pemetrexed + carboplatin with concurrent radiotherapy in inoperable stage III non-small cell lung cancer with EGFR mutation, the primary endpoint is progression-free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Icotinib with concurrent radiotherapy | Experimental | Drug: Icotinib, Radiation: Thoracic radiotherapy(TRT)Icotinib (125 mg ,three times daily)with concurrent thoracic radiotherapy(TRT) (66 Gy/33 fractions), followed by maintenance icotinib (125 mg ,Three times daily) until disease progression or unacceptable toxicity. |
| Chemoradiotherapy | Active comparator | Drug: Pemetrexed, Drug: Carboplatin, Radiation: Thoracic radiotherapy(TRT)Pemetrexed(500mg/m2) + carboplatin (AUC，5) every 21 days for three cycles with concurrent thoracic radiotherapy(TRT) (66 Gy/33 fractions), followed by consolidation chemotherapy with two cycles of pemetrexed(500mg/m2) + carboplatin (AUC，5) every 21 days.Maintenance pemetrexed(500mg/m2) will be administered after consolidation chemotherapy 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 (6 listed)
- Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation.
- No previous systemic anticancer therapy.
- life expectancy more than three months.
- ECOG Performance Status of 0 to 1.
- Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
Key exclusion criteria (4 listed)
- Intrapulmonary metastasis, atelectasis of an entire hemithorax,pleural dissemination, or contralateral hilar lymph node metastasis.
- Prior chemotherapy for NSCLC, chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway.
- Severe heart disease, uncontrolled diabetes mellitus, or active infection.
- Active concomitant malignancy, and pregnancy or breast-feeding.
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: BPI-2009, ConmanaIcotinib (125 mg ,Three times daily) | Drug | Icotinib with concurrent radiotherapy |
| PemetrexedAlso: Alimta, LY231514, MTA, Multitargeted AntifolatePemetrexed(500mg/m2)every 21 days | Drug | Chemoradiotherapy |
| CarboplatinAlso: ParaplatinCarboplatin (AUC，5) every 21 days | Drug | Chemoradiotherapy |
| Thoracic radiotherapy(TRT)TRT (total dose 66Gy, 2Gy per time, once a day, five times a week, a total of 33 times) | Radiation | Chemoradiotherapy, Icotinib with concurrent radiotherapy |
Primary outcome
Progression free survival (PFS)
Time frame: One year
A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.
4 secondary outcomes
Overall survival(OS)
Time frame: two years
Adverse events
Time frame: two years
Objective response rate
Time frame: two years
Quality of life
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2015.
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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.
GuoSheng Feng, MD study chair
The People's hospital of Guangxi Zhuang Autonomous
Yuan Liang, MD study chair
Guangxi Department of Public Health
Lin Hui, MD study chair
The People's hospital of Guangxi Zhuang Autonomous
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, Pemetrexed and Carboplatin in people with Non-small Cell Lung Cancer, run by People's Hospital of Guangxi Zhuang Autonomous Region 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 6 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 2 Apr 2015. 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 Xia Wu, intern (+86-185-789-52759, 353992578@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: One year). 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 2 Apr 2015.