Neoplasms, LungPhase 2NCT01131429
A Chinese Randomized Crossover Study of Erlotinib Versus Docetaxel/Cisplatin in Previously Untreated Stage IIIB/IV Lung Adenocarcinoma With EGFR Mutations
A Phase 2 study testing Erlotinib, Docetaxel and Cisplatin in people with Neoplasms, Lung and Carcinoma, Non-Small Cell Lung, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Objective: the objective of this study in china is to clarify, whether the overall survival is different between previously untreated stage IIIB/IV lung adenocarcinoma with EGFR mutations receiving first-line erlotinib plus second-line docetaxel/cisplatin and those receiving first-line docetaxel/cisplatin plus… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Lung, Carcinoma, Non-Small Cell Lung, Drug Therapy
- What is being tested?
- Erlotinib, Docetaxel and Cisplatin
- 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
- Jun 2010to Jun 2015
- 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
- Male and female patients aged over 18 years
- Histologically proven lung adenocarcinoma
- clinical stage IIIB/IV
- ECOG performance status 0-2
- Had no prior anticancer agent, radiation or surgical therapy for lung adenocarcinoma
- At least one measurable lesion (according to RECIST)
- Provision of written informed consent
- Life expectancy of at least 12 weeks
Who cannot join
- History of malignant disease.
- Evidence of clinically active interstitial lung diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
- Expected life expectancy less than 2 months
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x ULN if no demonstrable liver metastases (or >5 x in presence of liver metastases)
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
- Pregnancy or breast-feeding women (women of child¬bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Liang-An Chen, MD, phD, 86-10-66939361, chenla301@263.net
Liang-An Chen, MD, phD
About this study
Official title: Survival Analysis of A Chinese Randomized Crossover Study Comparing Erlotinib to Docetaxel/Cisplatin in Previously Untreated Stage IIIB/IV Lung Adenocarcinoma With EGFR Mutations
Objective: the objective of this study in china is to clarify, whether the overall survival is different between previously untreated stage IIIB/IV lung adenocarcinoma with EGFR mutations receiving first-line erlotinib plus second-line docetaxel/cisplatin and those receiving first-line docetaxel/cisplatin plus second-line erlotinib .
- Keywords
- mutation analysis, first-line, second-line, targeted therapy
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErlotinibDrug
Erlotinib 150 mg/d per os until proven disease progression
DocetaxelDrug
Docetaxel 75mg/m2 iv day 1 every 3 weeks as second-line treatment
CisplatinDrug
cisplatin 75mg/ m2 iv day 1 every 3 weeks as second-line treatment
DocetaxelDrug
Docetaxel 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most
CisplatinDrug
Cisplatin 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most
ErlotinibDrug
Erlotinib 150 mg/d per os as second-line treatment
| Study group | Role | What they receive |
|---|---|---|
| first-line erlotinib | Experimental | erlotinib in first-line treatment and docetaxel/cisplatin in second-line treatment Receives: Drug: Erlotinib; Drug: Docetaxel; Drug: Cisplatin |
| second-line erlotinib | Active comparator | docetaxel/cisplatin in first-line treatment and erlotinib in second-line treatment Receives: Drug: Docetaxel; Drug: Cisplatin; Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: three year
Secondary outcomes (9)
progression-free survival during the first-line treatment
Measured: 1 year
progression-free time during the second-line treatment
Measured: 2 years
quality of life during the first-line therapy
Measured: every 3 weeks during first-line therapy
quality of life during the second-line therapy
Measured: every 3 weeks during the second-line therapy
response rates during the first-line treatment
Measured: at 6 months from treatment initiation
response rates during the second-line treatment
Measured: every 3 weeks during the treament, and and every 6 weeks thereafter
toxicity during the first-line treatment
Measured: at 12 months from treatment initiation
toxicity during the second-line treatment
Measured: end of study
preditive and prognostic markers for chemotherapy or erlotinib
tissues for markers analysis are acquired during diagnosis procedure with informed consent.
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2013 (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 Neoplasms, LungStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Liang-An Chen, M.D., Ph.D., Study chair, Chinese PLA General Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131429
- Sponsor's protocol ID
- PLAGH-TKIs
- Status last verified
- Apr 2010
- First submitted
- 25 May 2010
- Last updated
- 27 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Analysis of A Chinese Randomized Crossover Study Comparing Erlotinib to Docetaxel/Cisplatin in Previously Untreated Stage IIIB/IV Lung Adenocarcinoma With EGFR Mutations
- ClinicalTrials.gov ID
- NCT01131429
- Acronym / sponsor ID
- PLAGH-TKIs
- Keywords
- mutation analysis, first-line, second-line, targeted therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 27 May 2010 (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.
Objective: the objective of this study in china is to clarify, whether the overall survival is different between previously untreated stage IIIB/IV lung adenocarcinoma with EGFR mutations receiving first-line erlotinib plus second-line docetaxel/cisplatin and those receiving first-line docetaxel/cisplatin plus second-line erlotinib .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first-line erlotinib | Experimental | Drug: Erlotinib, Drug: Docetaxel, Drug: Cisplatinerlotinib in first-line treatment and docetaxel/cisplatin in second-line treatment |
| second-line erlotinib | Active comparator | Drug: Docetaxel, Drug: Cisplatin, Drug: Erlotinibdocetaxel/cisplatin in first-line treatment and erlotinib in second-line treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female patients aged over 18 years
- Histologically proven lung adenocarcinoma
- clinical stage IIIB/IV
- ECOG performance status 0-2
- Had no prior anticancer agent, radiation or surgical therapy for lung adenocarcinoma
Key exclusion criteria (7 listed)
- History of malignant disease.
- Evidence of clinically active interstitial lung diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
- Expected life expectancy less than 2 months
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x ULN if no demonstrable liver metastases (or >5 x in presence of liver metastases)
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 |
|---|---|---|
| ErlotinibErlotinib 150 mg/d per os until proven disease progression | Drug | first-line erlotinib |
| DocetaxelDocetaxel 75mg/m2 iv day 1 every 3 weeks as second-line treatment | Drug | first-line erlotinib |
| Cisplatincisplatin 75mg/ m2 iv day 1 every 3 weeks as second-line treatment | Drug | first-line erlotinib |
| DocetaxelDocetaxel 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most | Drug | second-line erlotinib |
| CisplatinCisplatin 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most | Drug | second-line erlotinib |
| ErlotinibErlotinib 150 mg/d per os as second-line treatment | Drug | second-line erlotinib |
Primary outcome
Overall survival
Time frame: three year
9 secondary outcomes
progression-free survival during the first-line treatment
Time frame: 1 year
progression-free time during the second-line treatment
Time frame: 2 years
quality of life during the first-line therapy
Time frame: every 3 weeks during first-line therapy
quality of life during the second-line therapy
Time frame: every 3 weeks during the second-line therapy
response rates during the first-line treatment
Time frame: at 6 months from treatment initiation
response rates during the second-line treatment
Time frame: every 3 weeks during the treament, and and every 6 weeks thereafter
toxicity during the first-line treatment
Time frame: at 12 months from treatment initiation
toxicity during the second-line treatment
Time frame: end of study
preditive and prognostic markers for chemotherapy or erlotinib
Time frame: end of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2010.
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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.
Liang-An Chen, M.D., Ph.D. study chair
Chinese PLA General Hospital, Beijing, China
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 Erlotinib, Docetaxel and Cisplatin in people with Neoplasms, Lung and Carcinoma, Non-Small Cell Lung, run by Chinese PLA General 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 8 inclusion and 7 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 27 May 2010. 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 Liang-An Chen, MD, phD (86-10-66939361, chenla301@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: three 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 27 May 2010.