Non Small Cell Lung CancerPhase 2NCT00891579
Study of Pemetrexed Versus Gefitinib in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy Without Epidermal Growth Factor Receptor (EGFR) Mutations
A Phase 2 study testing Pemetrexed (Alimta) and Gefitinib (IRESSA) in people with Non Small Cell Lung Cancer, run by Chinese Society of Lung Cancer at 7 sites in China.
Trial summary
This study is a prospective trial of Alimta (pemetrexed) versus IRESSA (gefitinib) among epidermal growth factor receptor wild-type Non-Small Cell Lung Cancer (NSCLC) patients in a 2nd line setting. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Pemetrexed (Alimta) and Gefitinib (IRESSA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 7 sitesChina
- Study dates
- Feb 2009to Nov 2012
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent must be signed.
- At least 18 years of age.
- Histologic or cytologic diagnosis of NSCLC.
- Locally advanced or metastatic disease (stage IIIB, or IV) that is not amenable to definitive surgery or radiotherapy.
- Patients must have previously received one platinum-based chemotherapy regimen for palliative therapy of locally advanced or metastatic disease. Patients are also eligible if they have received one platinum-based chemotherapy regimen as neoadjuvant or adjuvant chemotherapy and the disease recurred within six months since the finishing of neoadjuvant or adjuvant chemotherapy.
- Without EGFR mutations.
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- At least one measurable lesion as defined by RECIST criteria.
- ECOG PS0 - 2.
- Adequate organ function including the following:
- bone marrow;
- hepatic;
- renal.
- Prior chemotherapy must be completed at least 3 weeks prior to the study enrollment, and the patient must have recovered from the toxic effects of the treatment (except for alopecia).
- Previous palliative radiation therapy is allowed, but limited in LESS 25% of the bone marrow and must not have included whole pelvis radiation. Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed one month before study entry. Radiotherapy should not be administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented.
- Estimated life expectancy of at least 8 weeks.
- For women:
- must be surgically sterile;
- postmenopausal; OR
- compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have negative serum or urine pregnancy test and must not be lactating.
- For men:
- must be surgically sterile; OR
- compliant with a contraceptive regimen during and for 3 months after the treatment period.
- Patient compliance and geographic proximity that allow adequate follow-up.
Who cannot join
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry or concurrent administration of any other anti-tumor therapy.
- Have previously participated in a study involving pemetrexed or EGFR-TKI
- Hypersensitivity to pemetrexed or gefitinib or any ingredients in the two drugs.
- Symptomatic central nervous system (CNS) metastases and asymptomatic CNS metastases requiring concurrent corticosteroid therapy. Treated stable CNS metastases are allowed; the patient must be stable after radiotherapy for more than 2 weeks and off of corticosteroids for more than 1 week. .
- History of another malignancy within the last 5 years except cured carcinoma in-situ of uterine cervix, cured basal cell carcinoma of skin and superficial bladder tumors (Ta, Tis and T1)
- Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
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- Patients with interstitial lung disease.
- Any unstable systemic disease (including active infection, hepatic, renal or metabolic disease) or serious concomitant disorders that would compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator.
- Significant cardiovascular event: congestive heart failure >NYHA class 2; unstable angina, active CAD (myocardial infarction more than 1 year prior to study entry is allowed); serious cardiac arrhythmia requiring antiarrythmic therapy ( beta blockers or digoxin are permitted) or uncontrolled hypertension.
- History of significant neurological or mental disorder, including seizures or dementia.
- Incision from operation has not healed before the start of study treatment (Small incision for biopsy is eligible.)
- Pregnant or breast-feeding women and childbearing potential women with either a positive or no pregnancy test within 48 hours of the start of treatment. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential.
- Concurrent use of St. John's Wort, Rifampicin, and/or ritonavir.
- Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of pemetrexed. If a patient is taking an NSAID (Cox-2 inhibitors included) or salicylate with a long half-life (e.g., naproxen, piroxicam, diflunisal, nabumetone, rofecoxib, or celecoxib) it should not be taken 5 days before, the day of, and 2 days after the dose of pemetrexed.
- Presence of clinically detectable (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
- Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
307 hospital of People's Liberation Army
Beijing
Peking Union Hospital
Beijing
Jilin Tumor Hospital
Changchun
Lung Cancer Research Institute & Cancer Center of Guangdong General Hospital
Guangzhou, Guangdong, 510080
Nanjing General Hospital of Nanjing Military Command
Nanjing
Shanghai Chest Hospital
Shanghai
The first hospital of China medical university
Shenyang
About this study
Official title: Phase 2 Randomized, Controlled, Open-label Study of Pemetrexed Versus Gefitinib in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy Without EGFR Mutations
This study is a prospective trial of Alimta (pemetrexed) versus IRESSA (gefitinib) among epidermal growth factor receptor wild-type Non-Small Cell Lung Cancer (NSCLC) patients in a 2nd line setting.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Pemetrexed (Alimta), Gefitinib (IRESSA)
- Keywords
- NSCLC, EGFR, Pemetrexed, Gefitinib, without EGFR mutations
- 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.
Pemetrexed (Alimta)Drug
treatment of single pemetrexed with vitamin supplement until discontinued conditions are met
Gefitinib (IRESSA)Drug
treatment of Gefitinib will be applied until discontinued conditions are met
| Study group | Role | What they receive |
|---|---|---|
| Alimta | Active comparator | Treatment of Alimta Receives: Drug: Pemetrexed (Alimta) |
| IRESSA | Active comparator | Treatment of IRESSA Receives: Drug: Gefitinib (IRESSA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Measured: 2 years
Secondary outcomes (2)
Response rate (RR)
Measured: 2 years
Overall survival (OS)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startFeb 2009
- Primary completionSep 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Society of Lung Cancer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Long Wu, Chinese Society of Lung Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891579
- Sponsor's protocol ID
- C-TONG0806
- Status last verified
- Dec 2012
- First submitted
- 30 Apr 2009
- Last updated
- 10 Dec 2012
- Results posted
- No
Publications
Zhou Q, Cheng Y, Yang JJ, Zhao MF, Zhang L, Zhang XC, Chen ZH, Yan HH, Song Y, Chen JH, Feng WN, Xu CR, Wang Z, Chen HJ, Zhong WZ, Liu YP, Wu YL. Pemetrexed versus gefitinib as a second-line treatment in advanced nonsquamous nonsmall-cell lung cancer patients harboring wild-type EGFR (CTONG0806): a multicenter randomized trial. Ann Oncol. 2014 Dec;25(12):2385-2391. doi: 10.1093/annonc/mdu463. Epub 2014 Oct 3.
PubMed 25281710
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized, Controlled, Open-label Study of Pemetrexed Versus Gefitinib in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy Without EGFR Mutations
- ClinicalTrials.gov ID
- NCT00891579
- Acronym / sponsor ID
- C-TONG0806
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- NSCLC, EGFR, Pemetrexed, Gefitinib, without EGFR mutations
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Chinese Society of Lung CancerUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 1 May 2009 (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 study is a prospective trial of Alimta (pemetrexed) versus IRESSA (gefitinib) among epidermal growth factor receptor wild-type Non-Small Cell Lung Cancer (NSCLC) patients in a 2nd line setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alimta | Active comparator | Drug: Pemetrexed (Alimta)Treatment of Alimta |
| IRESSA | Active comparator | Drug: Gefitinib (IRESSA)Treatment of IRESSA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Informed consent must be signed.
- At least 18 years of age.
- Histologic or cytologic diagnosis of NSCLC.
- Locally advanced or metastatic disease (stage IIIB, or IV) that is not amenable to definitive surgery or radiotherapy.
- Patients must have previously received one platinum-based chemotherapy regimen for palliative therapy of locally advanced or metastatic disease. Patients are also eligible if they have received one platinum-based chemotherapy regimen as neoadjuvant or adjuvant chemotherapy and the disease recurred within six months since the finishing of neoadjuvant or adjuvant chemotherapy.
Key exclusion criteria (16 listed)
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry or concurrent administration of any other anti-tumor therapy.
- Have previously participated in a study involving pemetrexed or EGFR-TKI
- Hypersensitivity to pemetrexed or gefitinib or any ingredients in the two drugs.
- Symptomatic central nervous system (CNS) metastases and asymptomatic CNS metastases requiring concurrent corticosteroid therapy. Treated stable CNS metastases are allowed; the patient must be stable after radiotherapy for more than 2 weeks and off of corticosteroids for more than 1 week. .
- History of another malignancy within the last 5 years except cured carcinoma in-situ of uterine cervix, cured basal cell carcinoma of skin and superficial bladder tumors (Ta, Tis and T1)
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 |
|---|---|---|
| Pemetrexed (Alimta)treatment of single pemetrexed with vitamin supplement until discontinued conditions are met | Drug | Alimta |
| Gefitinib (IRESSA)treatment of Gefitinib will be applied until discontinued conditions are met | Drug | IRESSA |
Primary outcome
Progression free survival (PFS)
Time frame: 2 years
2 secondary outcomes
Response rate (RR)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
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 10 Dec 2012.
- Derived from this study: PubMed 25281710Zhou Q, Cheng Y, Yang JJ, Zhao MF, Zhang L, Zhang XC, Chen ZH, Yan HH, Song Y, Chen JH, Feng WN, Xu CR, Wang Z, Chen HJ, Zhong WZ, Liu YP, Wu YL. Pemetrexed versus gefitinib as a second-line treatment in advanced nonsquamous nonsmall-cell lung cancer patients harboring wild-type EGFR (CTONG0806): a multicenter randomized trial. Ann Oncol. 2014 Dec;25(12):2385-2391. doi: 10.1093/annonc/mdu463. Epub 2014 Oct 3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemetrexed (Alimta) and Gefitinib (IRESSA) in people with Non Small Cell Lung Cancer, run by Chinese Society of Lung Cancer at 7 sites 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 23 inclusion and 16 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 10 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
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?
Progression free survival (PFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00891579, which also lists 1 linked publication.
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 10 Dec 2012.