NSCLCPhase 4NCT02778893
Conmana Combined With Thalidomide to Treat NSCLC
A Phase 4 study testing Conmana and Thalidomide in people with NSCLC, run by Henan Provincial People's Hospital at 1 site in China.
Trial summary
Our study the NSCLC harbors EGFR-mutation with Conmana combined with thalidomide as first-line treatment, is expected to improve further EGFR-Tyrosine kinase inhibitors (TKI) response rate (ORR), prolong time to progression (PFS), improve patient survival. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Conmana and Thalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Mar 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have the ability to understand and the willingness to sign a written informed consent document.
- Patients be age >18 years and < 75 years. Patients must have a Life Expectancy of greater than 3 months.
- Patients must be NSCLC confirmed by Histological or cytological.
- Eastern Cooperative Oncology Group (ECOG) score standard: 0-2.
- Patients must have normal organ and marrow function as defined below, within two week prior to study: absolute neutrophil count>1,500/mL platelets>100,000/mL total bilirubin: within normal institutional limits Aspartate transaminase (AST)/Alanine aminotransferase (ALT) <2.5 times institutional upper limit of normal creatinine≤1.5 times institutional upper limit of normal urine dipstick for proteinuria of < less than 1+. If urine dipstick is > 1+ then a 24 hour urine for protein must demonstrate <500mg of protein in 24 hours to allow participation in the study.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Judging by the researchers, that patients can comply with the program.
Who cannot join
- Women that are pregnant or breastfeeding Note: Pregnant women are excluded from this study because the agents used in this study may be teratogenic to a fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with thalidomide, breastfeeding women are also excluded from this study.
- During the course of the treatment, the serious active infection of intravenous injection of antibiotics is required.
- Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to thalidomide and icotinib or other agents used in the study are excluded.
- A person who is not effectively controlled, has symptoms of brain metastases, or suffers from a mental disorder that is not easily controlled; has a severe mental or cognitive impairment.
- Congestive heart failure, arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack in 6 months.
- 5 years of suffering from other malignancies, except for the treatment of cervical carcinoma in situ or skin squamous cell carcinoma of the skin, or the basic control of skin basal cell carcinoma.
- Can not follow the test program or can not meet the follow-up of patients.
- The researchers think it is not appropriate to participate in this trial.
Trial locations and contacts
1 site in 1 country.
an yunxia contact
China1 site, 1 recruiting
- Recruiting
XZhang
Zhengzhou, Henan, 450000
zhang xiaoju, 15837101166
zhang xiaoju
About this study
Official title: A Phase Ⅳ,Open,Multicenter,Single Arm Study to Evaluate the Efficacy of the Combination Conmana With Thalidomide in Patients With NSCLC(Non-Small-Cell-Lung-Cancer)
Our study the NSCLC harbors EGFR-mutation with Conmana combined with thalidomide as first-line treatment, is expected to improve further EGFR-Tyrosine kinase inhibitors (TKI) response rate (ORR), prolong time to progression (PFS), improve patient survival.
Read the detailed description
Primary Objective:
To evaluate the efficacy, survival and side effects of the combined therapy, and to evaluate the effectiveness and safety of thalidomide with Conmana in patients who harbors EGFR mutations.
- Conditions
- NSCLC
- Being tested
- Conmana, Thalidomide
- Keywords
- Conmana, Thalidomide, NSCLC, EGFR mutation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConmanaDrug
Also called Icotinib, Icotinib Hydrochloride Tablets
125mg three times a day (TID) continuously
ThalidomideDrug
Also called Sedoval, Thalomid, Celgene Brand of Thalidomide
100mg one a day（QD）at night continuously,If can tolerance after 1 weeks to add to 200mg;
| Study group | Role | What they receive |
|---|---|---|
| Conmana and Thalidomide | Experimental | Conmana(Icotinib Hydrochloride Tablets) and Thalidomide:
Conmana(Icotinib Hydrochloride Tablets) will be administered at 125mg three times a day(TID）continuously; Thalidomide will be administered at 100mg one a day（QD)at night continuously,If can tolerance after 1 weeks to add to 200mg. Receives: Drug: Conmana; Drug: Thalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 years the progression-free survival (PFS) rate of the combination of thalidomide with gefitinib in patients who harbors EGFR mutations.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XiaoJu Zhang, Henan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778893
- Sponsor's protocol ID
- ICO-01
- Status last verified
- May 2016
- First submitted
- 11 May 2016
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅳ,Open,Multicenter,Single Arm Study to Evaluate the Efficacy of the Combination Conmana With Thalidomide in Patients With NSCLC(Non-Small-Cell-Lung-Cancer)
- ClinicalTrials.gov ID
- NCT02778893
- Acronym / sponsor ID
- ICO-01
- Conditions
- NSCLC
- Keywords
- Conmana, Thalidomide, NSCLC, EGFR mutation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 20 May 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.
Our study the NSCLC harbors EGFR-mutation with Conmana combined with thalidomide as first-line treatment, is expected to improve further EGFR-Tyrosine kinase inhibitors (TKI) response rate (ORR), prolong time to progression (PFS), improve patient survival.
Detailed description
Primary Objective:
To evaluate the efficacy, survival and side effects of the combined therapy, and to evaluate the effectiveness and safety of thalidomide with Conmana in patients who harbors EGFR mutations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conmana and Thalidomide | Experimental | Drug: Conmana, Drug: ThalidomideConmana(Icotinib Hydrochloride Tablets) and Thalidomide: Conmana(Icotinib Hydrochloride Tablets) will be administered at 125mg three times a day(TID）continuously; Thalidomide will be administered at 100mg one a day（QD)at night continuously,If can tolerance after 1 weeks to add to 200mg. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have the ability to understand and the willingness to sign a written informed consent document.
- Patients be age >18 years and < 75 years. Patients must have a Life Expectancy of greater than 3 months.
- Patients must be NSCLC confirmed by Histological or cytological.
- Eastern Cooperative Oncology Group (ECOG) score standard: 0-2.
- Patients must have normal organ and marrow function as defined below, within two week prior to study: absolute neutrophil count>1,500/mL platelets>100,000/mL total bilirubin: within normal institutional limits Aspartate transaminase (AST)/Alanine aminotransferase (ALT) <2.5 times institutional upper limit of normal creatinine≤1.5 times institutional upper limit of normal urine dipstick for proteinuria of < less than 1+. If urine dipstick is > 1+ then a 24 hour urine for protein must demonstrate <500mg of protein in 24 hours to allow participation in the study.
Key exclusion criteria (8 listed)
- Women that are pregnant or breastfeeding Note: Pregnant women are excluded from this study because the agents used in this study may be teratogenic to a fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with thalidomide, breastfeeding women are also excluded from this study.
- During the course of the treatment, the serious active infection of intravenous injection of antibiotics is required.
- Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to thalidomide and icotinib or other agents used in the study are excluded.
- A person who is not effectively controlled, has symptoms of brain metastases, or suffers from a mental disorder that is not easily controlled; has a severe mental or cognitive impairment.
- Congestive heart failure, arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack in 6 months.
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 |
|---|---|---|
| ConmanaAlso: Icotinib, Icotinib Hydrochloride Tablets125mg three times a day (TID) continuously | Drug | Conmana and Thalidomide |
| ThalidomideAlso: Sedoval, Thalomid, Celgene Brand of Thalidomide100mg one a day（QD）at night continuously,If can tolerance after 1 weeks to add to 200mg; | Drug | Conmana and Thalidomide |
Primary outcome
5 years the progression-free survival (PFS) rate of the combination of thalidomide with gefitinib in patients who harbors EGFR mutations.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
- Individual participant dataSharing planned: Yes
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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.
an yunxia contact
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 Conmana and Thalidomide in people with NSCLC, run by Henan Provincial People's 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 7 inclusion and 8 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 20 May 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 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 zhang xiaoju (15837101166, 15837101166@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5 years the progression-free survival (PFS) rate of the combination of thalidomide with gefitinib in patients who harbors EGFR mutations. (time frame: 5 years). 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 20 May 2016.