Non-small Cell Lung CancerPhase 3ISCANNCT01404260
Intercalating and Maintenance Use of Iressa Versus Chemotherapy in Selected Advanced Non Small Cell Lung Cancer
A Phase 3 study testing Gefitinib and Gemcitabine +Carboplatin in people with Non-small Cell Lung Cancer, run by Guangdong Association of Clinical Trials at 1 site in China.
Trial summary
Platinum-based combination chemotherapy, such as gemcitabine-carboplatin, is one of the standard first-line therapy for advanced non-small cell lung cancer (NSCLC). Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) have clinical efficacy, as compared with the best supportive care or standard… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Gefitinib and Gemcitabine +Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteChina
- Study dates
- Jun 2011to Oct 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- After two cycles chemotherapy(gemcitabine plus carboplatin), patients with stable disease(SD) by RECIST1.1.
- Patients between 18 and 75 years of age.
- Present with histologically proven or cytological diagnosis of adenocarcinoma NSCLC Stage IIIB or IV as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer, that is not amenable to curative therapy,such as surgery or radiotherapy and so on.
- No prior systemic chemotherapy or targeted therapy for lung cancer before screening.
- Never smokers(defined as having smoked less than 100 cigarettes in their lifetime ) or light ex-smokers (defined as having ceased smoking at least 15 years before Day 1 of study treatment and having smoked 10 pack-years or fewer).
- EGFR mutation status unknown.
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- ECOG performance status of 0 or 1.
- Adequate organ function.
- Prior radiation therapy allowed to <25% of the bone marrow . Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 4 weeks before study enrollment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.
- Signed informed consent document on file.
- Estimated life expectancy of ≥12 weeks.
- Patient compliance and geographic proximity that allow adequate follow up.
Who cannot join
- Known severe hypersensitivity to gefitinib.
- Sympotomatic patients with brain metastases.
- Pleural effusion or pericardiac effusion that cannot be controlled by drainage or other procedures.
- Inability to comply with protocol or study procedures.
- A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
- A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- Interstitial pneumonia.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Lung Tumor Clinical Center,Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
About this study
Official title: Intercalating and Maintenance Use of Iressa vs. Chemotherapy in Selected Advanced NSCLC: a Randomised Study
Platinum-based combination chemotherapy, such as gemcitabine-carboplatin, is one of the standard first-line therapy for advanced non-small cell lung cancer (NSCLC).
Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) have clinical efficacy, as compared with the best supportive care or standard chemotherapy, when given as second-line or third-line therapy for advanced NSCLC.
Read more
Treatment with EGFR-TKI is most effective in female, never-smoker, or patients with adenocarcinoma, and patients of Asian origin. In these populations, such treatment is associated with favorable objective response rates, progression-free survival, and overall survival. These populations also have a relatively high incidence of somatic mutations in the region of the EGFR gene that encodes the tyrosine kinase domain.
The recent study(IPASS) by Tony S. Mok showed gefitinib was superior to carboplatin-paclitaxel as an initial treatment for pulmonary adenocarcinoma among nonsmokers or former light smokers in East Asia . In the subgroup of 261 patients who were positive for the EGFR gene mutation, PFS was significantly longer among those who received gefitinib than among those who received carboplatin-paclitaxel(HR= 0.48,P<0.001), whereas in the subgroup of 176 patients who were negative for the mutation, PFS was significantly longer among those who received carboplatin-paclitaxel(HR=2.85,P<0.001). Gefitinib treatment was well tolerated, with lower in hematologic toxicity, and no treatment-related interstitial lung disease.In this study(IPASS), only patients with a mutation of the EGFR gene in the tumor could get benefit from gefitinib as first line treatment.
Tony S. Mok and his colleague also found that intercalating and maintenance administration of erlotinib(another EGFR-TKI)following gemcitabine/platinum chemotherapy as first line therapy led to a significant improvement in PFS .
Read the detailed description
Nowadays,EGFR mutation status is unknown for most of the advanced NSCLC patients in clinical practice.Those patients with high probability of EGFR mutation maybe could get benefit from gefitinib as first-line treatment. For this reason, the investigators need more investigation to focus on EGFR mutation unknown patients. In the previous study (including FAST-ACT), the patients enrolled trial received EGFR-TKI plus chemotherapy nearly simultaneously,so the investigators could not know whether those patients gained benefit from EGFR-TKI or chemotherapy, maybe chemotherapy alone was enough. If the patients with EGFR mutation status unknown could get stable disease(SD) after two cycles of chemotherapy,those patients may be optimal for the investigation of intercalating and maintenance administration of gefitinib. The reasons are that chemotherapy may be enough for those with objective response after two cycles chemotherapy, of course, those with disease progression (PD) should be excluded from the study.
On the basis of these and other studies, the investigators hypothesized that in a selected population,first-line chemotherapy(gemcitabine +carboplatin) with intercalating and maintenance use of gefitinib would be more efficacious than chemotherapy alone. In this study, the investigators compared the efficacy, safety, and adverse-event profile of chemotherapy plus gefitinib with those of chemotherapy alone, when these drugs were used as first-line treatment in nonsmokers or former light smokers in China, who had lung adenocarcinoma with EGFR gene mutation unknown.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Gefitinib, Gemcitabine +Carboplatin
- Keywords
- chemotherapy, maintenance therapy, gefitinib
- 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.
GefitinibDrug
Also called Iressa
Gefitinib 250mg/d every cycle d15-25,and Gefitinib 250mg/d from d15 of last cycle until disease progression
Gemcitabine +CarboplatinDrug
Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine +Carboplatin +Gefitinib | Experimental | Arm A: Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, Gefitinib 250mg/d every cycle d15-25, and Gefitinib 250mg/d from d15 of last cycle until disease progression Receives: Drug: Gefitinib; Drug: Gemcitabine +Carboplatin |
| Gemcitabine +Carboplatin | Active comparator | Arm B: Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression Receives: Drug: Gemcitabine +Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or progression in existing non-target lesions,or the appearance of one or more new lesions .
Measured: The evaluation of disease is demanded every two months for the patients receiving maintenance use of Gefitinib or patients in observation after chemotherapy,until disease progression occured
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionMar 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Association of Clinical Trials
- Sponsor type
- University, hospital or other
- Collaborators
- The First Hospital of Jilin University, Ruijin Hospital, Fudan University, Jiangsu Cancer Institute & Hospital, Nanjing PLA General Hospital, Wuxi No. 4 People's Hospital, The First Affiliated Hospital of Soochow University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Sir Run Run Shaw Hospital, Henan Cancer Hospital, Changhai Hospital, NanJing PLA 81 Hospital, First People's Hospital of Hangzhou
- Responsible party
- Principal investigator, Lu shun, Guangdong Association of Clinical Trials
- Investigators
- Shun Lu, MD., Principal investigator, Guangdong Province Clinical Trial Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404260
- Sponsor's protocol ID
- CTONG 1102
- Acronym
- ISCAN
- Status last verified
- Dec 2016
- First submitted
- 26 Jul 2011
- Last updated
- 27 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intercalating and Maintenance Use of Iressa vs. Chemotherapy in Selected Advanced NSCLC: a Randomised Study
- ClinicalTrials.gov ID
- NCT01404260
- Acronym / sponsor ID
- ISCAN / CTONG 1102
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- chemotherapy, maintenance therapy, gefitinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Guangdong Association of Clinical TrialsUniversity, hospital or other
- Collaborators
- The First Hospital of Jilin University, Ruijin Hospital, Fudan University, Jiangsu Cancer Institute & Hospital, Nanjing PLA General Hospital, Wuxi No. 4 People's Hospital, The First Affiliated Hospital of Soochow University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Sir Run Run Shaw Hospital, Henan Cancer Hospital, Changhai Hospital, NanJing PLA 81 Hospital, First People's Hospital of Hangzhou
- Study start
- Jun 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 28 Jul 2011 (estimated)
- Results
- Posted 27 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Platinum-based combination chemotherapy, such as gemcitabine-carboplatin, is one of the standard first-line therapy for advanced non-small cell lung cancer (NSCLC).
Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) have clinical efficacy, as compared with the best supportive care or standard chemotherapy, when given as second-line or third-line therapy for advanced NSCLC.
Treatment with EGFR-TKI is most effective in female, never-smoker, or patients with adenocarcinoma, and patients of Asian origin. In these populations, such treatment is associated with favorable objective response rates, progression-free survival, and overall survival. These populations also have a relatively high incidence of somatic mutations in the region of the EGFR gene that encodes the tyrosine kinase domain.
The recent study(IPASS) by Tony S. Mok showed gefitinib was superior to carboplatin-paclitaxel as an initial treatment for pulmonary adenocarcinoma among nonsmokers or former light smokers in East Asia . In the subgroup of 261 patients who were positive for the EGFR gene mutation, PFS was significantly longer among those who received gefitinib than among those who received carboplatin-paclitaxel(HR= 0.48,P<0.001), whereas in the subgroup of 176 patients who were negative for the mutation, PFS was significantly longer among those who received carboplatin-paclitaxel(HR=2.85,P<0.001). Gefitinib treatment was well tolerated, with lower in hematologic toxicity, and no treatment-related interstitial lung disease.In this study(IPASS), only patients with a mutation of the EGFR gene in the tumor could get benefit from gefitinib as first line treatment.
Tony S. Mok and his colleague also found that intercalating and maintenance administration of erlotinib(another EGFR-TKI)following gemcitabine/platinum chemotherapy as first line therapy led to a significant improvement in PFS .
Detailed description
Nowadays,EGFR mutation status is unknown for most of the advanced NSCLC patients in clinical practice.Those patients with high probability of EGFR mutation maybe could get benefit from gefitinib as first-line treatment. For this reason, the investigators need more investigation to focus on EGFR mutation unknown patients. In the previous study (including FAST-ACT), the patients enrolled trial received EGFR-TKI plus chemotherapy nearly simultaneously,so the investigators could not know whether those patients gained benefit from EGFR-TKI or chemotherapy, maybe chemotherapy alone was enough. If the patients with EGFR mutation status unknown could get stable disease(SD) after two cycles of chemotherapy,those patients may be optimal for the investigation of intercalating and maintenance administration of gefitinib. The reasons are that chemotherapy may be enough for those with objective response after two cycles chemotherapy, of course, those with disease progression (PD) should be excluded from the study.
On the basis of these and other studies, the investigators hypothesized that in a selected population,first-line chemotherapy(gemcitabine +carboplatin) with intercalating and maintenance use of gefitinib would be more efficacious than chemotherapy alone. In this study, the investigators compared the efficacy, safety, and adverse-event profile of chemotherapy plus gefitinib with those of chemotherapy alone, when these drugs were used as first-line treatment in nonsmokers or former light smokers in China, who had lung adenocarcinoma with EGFR gene mutation unknown.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine +Carboplatin +Gefitinib | Experimental | Drug: Gefitinib, Drug: Gemcitabine +CarboplatinArm A: Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, Gefitinib 250mg/d every cycle d15-25, and Gefitinib 250mg/d from d15 of last cycle until disease progression |
| Gemcitabine +Carboplatin | Active comparator | Drug: Gemcitabine +CarboplatinArm B: Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- After two cycles chemotherapy(gemcitabine plus carboplatin), patients with stable disease(SD) by RECIST1.1.
- Patients between 18 and 75 years of age.
- Present with histologically proven or cytological diagnosis of adenocarcinoma NSCLC Stage IIIB or IV as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer, that is not amenable to curative therapy,such as surgery or radiotherapy and so on.
- No prior systemic chemotherapy or targeted therapy for lung cancer before screening.
- Never smokers(defined as having smoked less than 100 cigarettes in their lifetime ) or light ex-smokers (defined as having ceased smoking at least 15 years before Day 1 of study treatment and having smoked 10 pack-years or fewer).
Key exclusion criteria (8 listed)
- Known severe hypersensitivity to gefitinib.
- Sympotomatic patients with brain metastases.
- Pleural effusion or pericardiac effusion that cannot be controlled by drainage or other procedures.
- Inability to comply with protocol or study procedures.
- A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
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 |
|---|---|---|
| GefitinibAlso: IressaGefitinib 250mg/d every cycle d15-25,and Gefitinib 250mg/d from d15 of last cycle until disease progression | Drug | Gemcitabine +Carboplatin +Gefitinib |
| Gemcitabine +CarboplatinGemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles | Drug | Gemcitabine +Carboplatin, Gemcitabine +Carboplatin +Gefitinib |
Primary outcome
Progression Free Survival
Time frame: The evaluation of disease is demanded every two months for the patients receiving maintenance use of Gefitinib or patients in observation after chemotherapy,until disease progression occured
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or progression in existing non-target lesions,or the appearance of one or more new lesions .
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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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.
Shun Lu, MD. principal investigator
Guangdong Province Clinical Trial Association
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 Gefitinib and Gemcitabine +Carboplatin in people with Non-small Cell Lung Cancer, run by Guangdong Association of Clinical Trials 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 12 inclusion and 8 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 27 Jan 2017. 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?
Yes. Results are posted in the registry (first posted 27 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: The evaluation of disease is demanded every two months for the patients receiving maintenance use of Gefitinib or patients in observation after chemotherapy,until disease progression occured). 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 Jan 2017.