Lung AdenocarcinomaPhase 2NCT02737774
Alternating Icotinib and Chemotherapy for Advanced Non-small Cell Lung Cancer With EGFR Mutation
A Phase 2 study testing Icotinib and Pemetrexed/Carboplatin in people with Lung Adenocarcinoma, run by Henan Cancer Hospital at 1 site in China.
Trial summary
This is a prospective, open, single-center, phase Ⅱ study to assess the efficacy and safety of alternating Icotinib and chemotherapy for advanced non-small cell lung cancer with EGFR mutation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Adenocarcinoma
- What is being tested?
- Icotinib and Pemetrexed/Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2016to 1 Jun 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological confirmation of non-small cell lung cancer (NSCLC) in phase ⅢB or phase Ⅳ.
- Positive EGFR mutation(19 exon or 21 exon)。
Who cannot join
- Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
- Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
- Allergic to icotinib
- metastases of spinal cord, meninges or meningeal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Armed Phase ⅡStudy of Alternating Icotinib and Chemotherapy for Advanced Non-small Cell Lung Cancer With EGFR Mutation
This is a prospective, open, single-center, phase Ⅱ study to assess the efficacy and safety of alternating Icotinib and chemotherapy for advanced non-small cell lung cancer with EGFR mutation.
- Conditions
- Lung Adenocarcinoma
- Being tested
- Icotinib, Pemetrexed/Carboplatin
- Keywords
- Icotinib, chemotherapy, EGFR
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcotinibDrug
All cases that meet the criteria take Icotinib for 18 weeks, If there is no disease progression, then after 14 days of washout period, received 4 cycles of pemetrexed / carboplatin. After the chemotherapy, continue with Icotinib, 125mg Tid，PO. until disease progression.
Pemetrexed/CarboplatinDrug
All cases that meet the criteria take Icotinib for 18 weeks, If there is no disease progression, then after 14 days of washout period, received 4 cycles of pemetrexed / carboplatin (standard solution, 3 weeks for a cycle of chemotherapy : pemetrexed 500mg/m2 iv , 4 cycles. carboplatin AUC=5 iv ,4 cycles.). After the chemotherapy, continue with Icotinib, 125mg Tid，PO. until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Icotinib and Pemetrexed/Carboplatin | Experimental | Icotinib: Icotinib for 18 weeks, 125mg Tid，PO. Chemotherapy: pemetrexed 500mg/m2 iv , 4 cycles. carboplatin AUC=5 iv ,4 cycles.
Then continue with Icotinib, 125mg Tid，PO. until disease progression. Receives: Drug: Icotinib; Drug: Pemetrexed/Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: from the day confirmed NSCLC to the day of first detecting progression, up to 24 months
Secondary outcomes (1)
overall survival time
Measured: from the day confirmed NSCLC to the day of death, up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study start13 Apr 2016
- Primary completion25 Oct 2019
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Qiming Wang, Henan Cancer Hospital
- Investigators
- Qiming Wang, Ph.D, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737774
- Sponsor's protocol ID
- HenanCH HX3001
- Status last verified
- Jun 2020
- First submitted
- 5 Apr 2016
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sun X, Zheng Y. Retreatment with icotinib in a patient with metastatic lung adenocarcinoma. Tumori. 2013 May-Jun;99(3):e124-6. doi: 10.1177/030089161309900331.
PubMed 24158081Zheng Y, Fang W, Deng J, Zhao P, Xu N, Zhou J. Sequential treatment of icotinib after first-line pemetrexed in advanced lung adenocarcinoma with unknown EGFR gene status. J Thorac Dis. 2014 Jul;6(7):958-64. doi: 10.3978/j.issn.2072-1439.2014.07.18.
PubMed 25093093Wang DS, Patel A, Shukla S, Zhang YK, Wang YJ, Kathawala RJ, Robey RW, Zhang L, Yang DH, Talele TT, Bates SE, Ambudkar SV, Xu RH, Chen ZS. Icotinib antagonizes ABCG2-mediated multidrug resistance, but not the pemetrexed resistance mediated by thymidylate synthase and ABCG2. Oncotarget. 2014 Jun 30;5(12):4529-42. doi: 10.18632/oncotarget.2102.
PubMed 24980828
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Armed Phase ⅡStudy of Alternating Icotinib and Chemotherapy for Advanced Non-small Cell Lung Cancer With EGFR Mutation
- ClinicalTrials.gov ID
- NCT02737774
- Acronym / sponsor ID
- HenanCH HX3001
- Conditions
- Lung Adenocarcinoma
- Keywords
- Icotinib, chemotherapy, EGFR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 13 Apr 2016 (actual)
- Primary completion
- 25 Oct 2019 (actual)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 14 Apr 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 is a prospective, open, single-center, phase Ⅱ study to assess the efficacy and safety of alternating Icotinib and chemotherapy for advanced non-small cell lung cancer with 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 and Pemetrexed/Carboplatin | Experimental | Drug: Icotinib, Drug: Pemetrexed/CarboplatinIcotinib: Icotinib for 18 weeks, 125mg Tid，PO. Chemotherapy: pemetrexed 500mg/m2 iv , 4 cycles. carboplatin AUC=5 iv ,4 cycles. Then continue with Icotinib, 125mg Tid，PO. until disease progression. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histological or cytological confirmation of non-small cell lung cancer (NSCLC) in phase ⅢB or phase Ⅳ.
- Positive EGFR mutation(19 exon or 21 exon)。
Key exclusion criteria (4 listed)
- Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
- Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
- Allergic to icotinib
- metastases of spinal cord, meninges or meningeal.
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 |
|---|---|---|
| IcotinibAll cases that meet the criteria take Icotinib for 18 weeks, If there is no disease progression, then after 14 days of washout period, received 4 cycles of pemetrexed / carboplatin. After the chemotherapy, continue with Icotinib, 125mg Tid，PO. until disease progression. | Drug | Icotinib and Pemetrexed/Carboplatin |
| Pemetrexed/CarboplatinAll cases that meet the criteria take Icotinib for 18 weeks, If there is no disease progression, then after 14 days of washout period, received 4 cycles of pemetrexed / carboplatin (standard solution, 3 weeks for a cycle of chemotherapy : pemetrexed 500mg/m2 iv , 4 cycles. carboplatin AUC=5 iv ,4 cycles.). After the chemotherapy, continue with Icotinib, 125mg Tid，PO. until disease progression. | Drug | Icotinib and Pemetrexed/Carboplatin |
Primary outcome
Progression Free Survival
Time frame: from the day confirmed NSCLC to the day of first detecting progression, up to 24 months
1 secondary outcome
overall survival time
Time frame: from the day confirmed NSCLC to the day of death, up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Background: PubMed 24158081Sun X, Zheng Y. Retreatment with icotinib in a patient with metastatic lung adenocarcinoma. Tumori. 2013 May-Jun;99(3):e124-6. doi: 10.1177/030089161309900331.
- Background: PubMed 25093093Zheng Y, Fang W, Deng J, Zhao P, Xu N, Zhou J. Sequential treatment of icotinib after first-line pemetrexed in advanced lung adenocarcinoma with unknown EGFR gene status. J Thorac Dis. 2014 Jul;6(7):958-64. doi: 10.3978/j.issn.2072-1439.2014.07.18.
- Background: PubMed 24980828Wang DS, Patel A, Shukla S, Zhang YK, Wang YJ, Kathawala RJ, Robey RW, Zhang L, Yang DH, Talele TT, Bates SE, Ambudkar SV, Xu RH, Chen ZS. Icotinib antagonizes ABCG2-mediated multidrug resistance, but not the pemetrexed resistance mediated by thymidylate synthase and ABCG2. Oncotarget. 2014 Jun 30;5(12):4529-42. doi: 10.18632/oncotarget.2102.
- Individual participant dataSharing planned: No
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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.
Qiming Wang, Ph.D principal investigator
Henan Cancer Hospital
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 and Pemetrexed/Carboplatin in people with Lung Adenocarcinoma, run by Henan Cancer Hospital 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 2 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 1 Jul 2020. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: from the day confirmed NSCLC to the day of first detecting progression, up to 24 months). 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 NCT02737774, which also lists 3 linked publications.
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 1 Jul 2020.