Non Small Cell Lung CancerPhase 2NCT02037997
Safety and Effectiveness Study of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With NSCLC
A Phase 2 study testing docetaxel, pemetrexed and Erlotinib in people with Non Small Cell Lung Cancer, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to evaluate and compare safety and effectiveness of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With EGFR - TKI Resistance of EGFR Mutations Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- docetaxel, pemetrexed and Erlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign the informed consent
- ≥18 years
- According to RECIST 1.1 standard, at least one measurable lesions
- Histology and cytology confirmed with unfavorable surgical locally advanced stage (stage IIIB) or metastatic NSCLC (IV), Sensitive EGFR gene mutation
- Palliative treatment has received two medicine first-line platinum-based chemotherapy and EGFR - TKI second-line treatment and objective clinical benefit (CR, PR or SD is more than 6 months), RESIST standard curative effect evaluation for progress
- PS=0,1,2
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- No serious blood, heart, lung, liver and kidney dysfunction, and immune deficiency
- Hb≥9g/dL；WBC≥3*109/L，ANC≥1.5*109/L，PLT≥75*109/L
- Men or women of childbearing age in the experiment are willing to take contraceptive measures
- Estimated survival period for 3 months or more
Who cannot join
- The palliative chemotherapy ever use docetaxel and pemetrexed
- small cell lung cancer non small cell hybrid
- Women during pregnancy or lactation
- In the past the anti-tumor treatment of any outstanding ease of > CTCAE 2 levels of toxicity
- Ccr<30 ml/min (calculated by Cockcroft-Gault formula)
- hepatic insufficiency： Tbil> 1.5×ULN ALT and AST > 2.5×ULN (Patients with liver metastasis>5×ULN) Alkaline phosphatase>2.5 ×ULN(Patients with liver metastasis>5×ULN)
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- Severe symptomatic heart disease
- Symptomatic brain metastases
- In the last 5 years have been or are suffering from other histological types of malignant tumor
- There are serious or uncontrolled systemic diseases
- During the study period planned radiotherapy on target lesion
- During the study period, plans to use other antineoplastic therapy
- Clinical study on treatment of 30 days beginning period prior to participate in any study drug
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Chang J hua, PD, 13916619284, changjianhua@163.com
About this study
Official title: Chemotherapy in Combination With Erlotinib, or Sequential Chemotherapy for Erlotinib for Treatment, EGFR - TKI Resistance of EGFR Mutations in Patients With NSCLC Randomized Controlled Phase II Clinical Study
The purpose of this study is to evaluate and compare safety and effectiveness of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With EGFR - TKI Resistance of EGFR Mutations
Read the detailed description
from the first cycle of treatment (day one) to two month after the last cycle
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- docetaxel, pemetrexed, Erlotinib
- Keywords
- PFS
- 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.
docetaxelDrug
docetaxel 75mg/m2 ivgtt D1
pemetrexedDrug
pemetrexed 500mg/m2 ivgtt D1
ErlotinibDrug
Erlotinib 150mg qd
| Study group | Role | What they receive |
|---|---|---|
| combination with Erlotinib | Experimental | Erlotinib 150mg qd combination with docetaxel 75mg/m2 or pemetrexed 500mg/m2 Receives: Drug: docetaxel; Drug: pemetrexed; Drug: Erlotinib |
| sequential chemotherapy for Erlotinib | Active comparator | docetaxel 75mg/m2 or pemetrexed 500mg/m2，after PD，Erlotinib 150mg qd Receives: Drug: docetaxel; Drug: pemetrexed; Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured: from the first cycle of treatment (day one) to two month after the last cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionDec 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 Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Jian Hua, Fudan University
- Investigators
- Chang J hua, PD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037997
- Sponsor's protocol ID
- CJH-Erlotinib-2013
- Status last verified
- Feb 2016
- First submitted
- 2 Jan 2014
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy in Combination With Erlotinib, or Sequential Chemotherapy for Erlotinib for Treatment, EGFR - TKI Resistance of EGFR Mutations in Patients With NSCLC Randomized Controlled Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT02037997
- Acronym / sponsor ID
- CJH-Erlotinib-2013
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- PFS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 Jan 2014 (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 purpose of this study is to evaluate and compare safety and effectiveness of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With EGFR - TKI Resistance of EGFR Mutations
Detailed description
from the first cycle of treatment (day one) to two month after the last cycle
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combination with Erlotinib | Experimental | Drug: docetaxel, Drug: pemetrexed, Drug: ErlotinibErlotinib 150mg qd combination with docetaxel 75mg/m2 or pemetrexed 500mg/m2 |
| sequential chemotherapy for Erlotinib | Active comparator | Drug: docetaxel, Drug: pemetrexed, Drug: Erlotinibdocetaxel 75mg/m2 or pemetrexed 500mg/m2，after PD，Erlotinib 150mg qd |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Sign the informed consent
- ≥18 years
- According to RECIST 1.1 standard, at least one measurable lesions
- Histology and cytology confirmed with unfavorable surgical locally advanced stage (stage IIIB) or metastatic NSCLC (IV), Sensitive EGFR gene mutation
- Palliative treatment has received two medicine first-line platinum-based chemotherapy and EGFR - TKI second-line treatment and objective clinical benefit (CR, PR or SD is more than 6 months), RESIST standard curative effect evaluation for progress
Key exclusion criteria (13 listed)
- The palliative chemotherapy ever use docetaxel and pemetrexed
- small cell lung cancer non small cell hybrid
- Women during pregnancy or lactation
- In the past the anti-tumor treatment of any outstanding ease of > CTCAE 2 levels of toxicity
- Ccr<30 ml/min (calculated by Cockcroft-Gault formula)
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 |
|---|---|---|
| docetaxeldocetaxel 75mg/m2 ivgtt D1 | Drug | combination with Erlotinib, sequential chemotherapy for Erlotinib |
| pemetrexedpemetrexed 500mg/m2 ivgtt D1 | Drug | combination with Erlotinib, sequential chemotherapy for Erlotinib |
| ErlotinibErlotinib 150mg qd | Drug | combination with Erlotinib, sequential chemotherapy for Erlotinib |
Primary outcome
Progression-free survival (PFS)
Time frame: from the first cycle of treatment (day one) to two month after the last cycle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
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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.
Chang J hua, PD principal investigator
Fudan University
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 docetaxel, pemetrexed and Erlotinib in people with Non Small Cell Lung Cancer, run by Fudan University 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 10 inclusion and 13 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 23 Feb 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 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 Chang J hua, PD (13916619284, changjianhua@163.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: from the first cycle of treatment (day one) to two month after the last cycle). 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 23 Feb 2016.