NSCLCPhase 2/3NCT01769066
Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum for Advanced NSCLC
A Phase 2/3 study testing Sequential Gefitinib With Pemetrexed/Platinum and Pemetrexed/Platinum in people with NSCLC, run by Fudan University at 1 site in China.
Trial summary
The aim of this study is to explore the Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum compare with Pemetrexed/Platinum for Advanced NSCLC. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Sequential Gefitinib With Pemetrexed/Platinum and Pemetrexed/Platinum
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to Feb 2014
- Phase
- Phase 2/3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18~70 years
- Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer
- Presence of at least one index lesion measurable by CT scan or MRI
- Ecog0-1
- Expected life time longer than 12 weeks
- Normal laboratory values:
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- leucocyte ≥ 4×109/L
- neutrophil ≥ 1.5×109/L
- platelet ≥ 100×109/L
- Hemoglobin ≥ 10g/L
- ALT and
- AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis)
- Signed written informed consent
Who cannot join
- Patients have used drugs according to protocol
- Patients were allergic to pemetrexed or cisplatin
- Patients received radiotherapy or other biological treatment 4 weeks before the trial
- Uncontrolled hydrothorax or hydropericardium
- neuropathy toxicity ≥ CTC 3
- Severe symptomatic heart disease
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- Active upper gastrointestinal ulcer or digestive disfunction
- Severe infection or metabolic disfunction
- Patients with other malignant tumor
- Uncontrolled brain metastases
- Patients have accepted other clinical trials
- Female patients during their pregnant and lactation period, or patients without contraception
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer hospital Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Random Open Exploratory Clinical Research of Sequential Gefitinib With Pemetrexed/Platinum Compare With Pemetrexed/Platinum Treatment for Advanced Non-small Cell Lung Cancer Exploratory Clinical Research
The aim of this study is to explore the Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum compare with Pemetrexed/Platinum for Advanced NSCLC.
Read the detailed description
Patients will be randomized to 2 groups
- Conditions
- NSCLC
- Being tested
- Sequential Gefitinib With Pemetrexed/Platinum, Pemetrexed/Platinum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential Gefitinib With Pemetrexed/PlatinumDrug
Pemetrexed/PlatinumDrug
| Study group | Role | What they receive |
|---|---|---|
| Sequential Gefitinib With Pemetrexed/Platinum | Experimental | Pemetrexed IV 500 mg/m2 ，DAY2 DDP IV 75mg/m2 ，DAY1 OR CAP IV AUC 5,DAY1 Gefitinib PO. 250mg DAY3-16 Receives: Drug: Sequential Gefitinib With Pemetrexed/Platinum |
| Pemetrexed/Platinum | Active comparator | Pemetrexed IV 500 mg/m2 ，DAY2 DDP IV 75mg/m2 ，DAY1 OR CAP IV AUC 5,DAY1 Receives: Drug: Pemetrexed/Platinum |
What is being measured
The primary outcome is the main question the study is designed to answer.
12 weeks of non-progression rate
Measured: from the first cycle of treatment (day one) to two month after the last cycle
Secondary outcomes (1)
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 2013 (estimated)
- Study startDec 2009
- Primary completionFeb 2014
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Jian Hua, Fudan University
- Investigators
- Chang jian hua, MD,PhD, Principal investigator, Cancer hospital Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769066
- Sponsor's protocol ID
- Gefitinib-2009-cjh
- Status last verified
- Feb 2016
- First submitted
- 10 Jan 2013
- Last updated
- 23 Feb 2016
- Results posted
- No
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
- Random Open Exploratory Clinical Research of Sequential Gefitinib With Pemetrexed/Platinum Compare With Pemetrexed/Platinum Treatment for Advanced Non-small Cell Lung Cancer Exploratory Clinical Research
- ClinicalTrials.gov ID
- NCT01769066
- Acronym / sponsor ID
- Gefitinib-2009-cjh
- Conditions
- NSCLC
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Feb 2014 (actual)
- First posted
- 16 Jan 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.
The aim of this study is to explore the Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum compare with Pemetrexed/Platinum for Advanced NSCLC.
Detailed description
Patients will be randomized to 2 groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequential Gefitinib With Pemetrexed/Platinum | Experimental | Drug: Sequential Gefitinib With Pemetrexed/PlatinumPemetrexed IV 500 mg/m2 ，DAY2 DDP IV 75mg/m2 ，DAY1 OR CAP IV AUC 5,DAY1 Gefitinib PO. 250mg DAY3-16 |
| Pemetrexed/Platinum | Active comparator | Drug: Pemetrexed/PlatinumPemetrexed IV 500 mg/m2 ，DAY2 DDP IV 75mg/m2 ，DAY1 OR CAP IV AUC 5,DAY1 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 18~70 years
- Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer
- Presence of at least one index lesion measurable by CT scan or MRI
- Ecog0-1
- Expected life time longer than 12 weeks
Key exclusion criteria (12 listed)
- Patients have used drugs according to protocol
- Patients were allergic to pemetrexed or cisplatin
- Patients received radiotherapy or other biological treatment 4 weeks before the trial
- Uncontrolled hydrothorax or hydropericardium
- neuropathy toxicity ≥ CTC 3
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 |
|---|---|---|
| Sequential Gefitinib With Pemetrexed/Platinum | Drug | Sequential Gefitinib With Pemetrexed/Platinum |
| Pemetrexed/Platinum | Drug | Pemetrexed/Platinum |
Primary outcome
12 weeks of non-progression rate
Time frame: from the first cycle of treatment (day one) to two month after the last cycle
1 secondary outcome
PFS
Time frame: from the first cycle of treatment (day one) to two month after the last cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 jian hua, MD,PhD principal investigator
Cancer hospital 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 2/3 study testing Sequential Gefitinib With Pemetrexed/Platinum and Pemetrexed/Platinum in people with NSCLC, 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 13 inclusion and 12 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: finished, 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 combined 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
12 weeks of non-progression rate (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.