Non-Small Cell Lung CancerPhase 3NCT02001896
Erlotinib Intercalated With Chemotherapy Versus Erlotinib as First Line Treatment in Stage IIIB/IV NSCLC Patients With EGFR Mutation
A Phase 3 study testing gemcitabine; cisplatin or carboplatin; erlotinib and erlotinib in people with Non-Small Cell Lung Cancer, run by Xinjiang Medical University at 1 site in China.
Trial summary
This 2 arm study will compare the efficacy and safety of treatment with erlotinib intercalated with platinum-based therapy or erlotinib along, as first line treatment in Stage IIIB/IV Non-Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Mutation. 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?
- gemcitabine; cisplatin or carboplatin; erlotinib and erlotinib
- 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
- Dec 2013to Jun 2015
- Phase
- Phase 3
- 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
- adult patients, >=18 years of age;advanced (stage IIIB/IV)non-small cell lung cancer;measurable disease;ECOG Performance Status 0-2.
Who cannot join
- prior exposure to agents directed at the HER axis;prior chemotherapy or systemic anti-tumor therapy after advanced disease;unstable systemic disease; any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix.
Trial locations and contacts
1 site in 1 country.
Qiang Wang, Master contact
China1 site
Xinjiang medical university
Ürümqi, Xinjiang, XJTHLC001
Li Shan, Master, 13609989394, shanlinew319@163.com
Qiang Wang, Master
About this study
Official title: A Randomized, Open-label Phase III Study of First-line Treatment With Erlotinib Intercalated With Gemcitabine/ Cisplatin or Carboplatin Therapy Versus Erlotinib in Stage IIIB/IV NSCLC Patients With EGFR Mutation
This 2 arm study will compare the efficacy and safety of treatment with erlotinib intercalated with platinum-based therapy or erlotinib along, as first line treatment in Stage IIIB/IV Non-Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Mutation. Patients will be randomized to receive gemcitabine (1000mg/m2 iv) on days 1 , and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by erlotinib 150mg/day from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by erlotinib monotherapy, or erlotinib 150mg/day .The anticipated time on study treatment is until disease progression, and the target sample size is 60 individuals.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- gemcitabine; cisplatin or carboplatin; erlotinib, erlotinib
- Keywords
- NSCLC, EGFR-TKI
- 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.
gemcitabine; cisplatin or carboplatin; erlotinibDrug
Also called tarceva
erlotinibDrug
Also called tarceva
| Study group | Role | What they receive |
|---|---|---|
| erlotinib combine with chemotherapy | Experimental | Drug: gemcitabine 1000mg/m2 iv on days 1 of each 4 week cycle for 6 cycles Drug: Platinum chemotherapy (cisplatin or carboplatin) cisplatin --75mg/m2 oon day 1 of each 4 week cycle for 6 cycles or carboplatin--5xAUC on day 1 of each 4 week cycle for 6 cycles Drug: Erlotinib[Tarceva] po on days 15-28 of each 4 week cycle until disease progression Receives: Drug: gemcitabine; cisplatin or carboplatin; erlotinib |
| erlotinib along | Active comparator | Drug: erlotinib [Tarceva] 150mg/day po until disease progression Receives: Drug: erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes (1)
Overall Survival
Measured: From date of randomization until the date of death from any cause, assessed up to 24 mont
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinjiang Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, li shan, Xinjiang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001896
- Sponsor's protocol ID
- XJTHLC001
- Status last verified
- Nov 2013
- First submitted
- 21 Nov 2013
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Phase III Study of First-line Treatment With Erlotinib Intercalated With Gemcitabine/ Cisplatin or Carboplatin Therapy Versus Erlotinib in Stage IIIB/IV NSCLC Patients With EGFR Mutation
- ClinicalTrials.gov ID
- NCT02001896
- Acronym / sponsor ID
- XJTHLC001
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- NSCLC, EGFR-TKI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xinjiang Medical UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 5 Dec 2013 (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 2 arm study will compare the efficacy and safety of treatment with erlotinib intercalated with platinum-based therapy or erlotinib along, as first line treatment in Stage IIIB/IV Non-Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Mutation. Patients will be randomized to receive gemcitabine (1000mg/m2 iv) on days 1 , and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by erlotinib 150mg/day from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by erlotinib monotherapy, or erlotinib 150mg/day .The anticipated time on study treatment is until disease progression, and the target sample size is 60 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| erlotinib combine with chemotherapy | Experimental | Drug: gemcitabine; cisplatin or carboplatin; erlotinibDrug: gemcitabine 1000mg/m2 iv on days 1 of each 4 week cycle for 6 cycles Drug: Platinum chemotherapy (cisplatin or carboplatin) cisplatin --75mg/m2 oon day 1 of each 4 week cycle for 6 cycles or carboplatin--5xAUC on day 1 of each 4 week cycle for 6 cycles Drug: Erlotinib[Tarceva] po on days 15-28 of each 4 week cycle until disease progression |
| erlotinib along | Active comparator | Drug: erlotinibDrug: erlotinib [Tarceva] 150mg/day po until disease progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients, >=18 years of age;advanced (stage IIIB/IV)non-small cell lung cancer;measurable disease;ECOG Performance Status 0-2.
Key exclusion criteria (1 listed)
- prior exposure to agents directed at the HER axis;prior chemotherapy or systemic anti-tumor therapy after advanced disease;unstable systemic disease; any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix.
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 |
|---|---|---|
| gemcitabine; cisplatin or carboplatin; erlotinibAlso: tarceva | Drug | erlotinib combine with chemotherapy |
| erlotinibAlso: tarceva | Drug | erlotinib along |
Primary outcome
Progression-free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
1 secondary outcome
Overall Survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 24 mont
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2013.
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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.
Qiang Wang, Master contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing gemcitabine; cisplatin or carboplatin; erlotinib and erlotinib in people with Non-Small Cell Lung Cancer, run by Xinjiang Medical 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 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 5 Dec 2013. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Li Shan, Master (13609989394, shanlinew319@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 (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 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 5 Dec 2013.