Non Small Cell Lung CancerPhase 3RANGENCT00807066
Randomized Gefitinib Trial
A Phase 3 study testing Gefitinib and Platinum in people with Non Small Cell Lung Cancer, run by Fondazione Humanitas per la Ricerca at 1 site in Italy.
Trial summary
Patients with locally advanced (IIIB with effusion) or metastatic non-small cell lung cancer (NSCLC), EGFR FISH positive, candidate for a first-line platinum-based chemotherapy will be considered eligible for the trial. 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?
- Gefitinib and Platinum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2008to Oct 2010
- 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
- Patients with locally advanced or metastatic NSCLC, EGFR FISH positive, candidate for a first-line platinum-based chemotherapy
- Histologically confirmed diagnosis of non-squamous NSCLC. Availability of tumor tissue for EGFR FISH analysis is mandatory
- Stage IIIB (with effusion) or stage IV or disease relapsed after surgery or radiotherapy and in any case not suitable for radiotherapy or surgery with curative intent
- EGFR FISH positive
- Presence of at least one measurable/evaluable not previously irradiated lesion according to RECIST criteria. Previously irradiated lesion(s) are allowed only if progressing
- ECOG performance Status 0-2
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- Patient untreated with chemotherapy or EGFR targeting agents. Adjuvant chemotherapy is allowed if disease relapsed after at least 12 months after therapy completion.
- Patient candidate to standard platinum-based chemotherapy
- Patient compliance to trial procedures
- Patients must be willing to complete the FACT-L questionnaire
- Age ≥ 18 years
Who cannot join
- EGFR FISH negative tumor
- Squamous-cell carcinoma, presence of neuroendocrine features or small cell carcinoma histology
- Impossibility to ascertain EGFR FISH status
- Concomitant radiotherapy
- Less than 30 days since completion of prior wide field chest radiotherapy or persistence of any radiotherapy related toxicity.
- Symptomatic brain metastases or newly diagnosed central nervous system (CNS) metastases that have not yet been definitively treated with surgery and/or radiation. Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically stable disease and are not receiving steroid therapy.
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- Known severe hypersensitivity to gefitinib or any of the excipients of this product
- Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
- All disease sites previously included in radiotherapy fields. If all sites were included in radiotherapy fields patient is eligible only if there is evidence of progressive disease after completion of radiotherapy.
- Diagnosis of any other malignancy during the last 5 years, except for in situ carcinoma of cervix uterine and squamous cell carcinoma of the skin
- Any previous chemotherapy or EGFR targeting agents
- Pregnancy or lactating. Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy
- Males must be willing to practice acceptable methods of birth control whilst taking study medication to prevent pregnancy of a partner.
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- Concomitant use of phenytoin, carbamazepine, rifampicin, rifabutin, barbiturates or St John's Wort (Hypercium).
- Serum bilirubin greater than 3 times the upper limit of reference range (ULRR
- Alanine amino transferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULRR if no demonstrable liver metastases or greater than 5 times the ULRR in the presence of liver metastases.
- Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentric Randomized Phase III Study Comparing Gefitinib Versus Platinum-Based Chemotherapy In EGFR Fish Positive NSCLC Patients (Range)
Patients with locally advanced (IIIB with effusion) or metastatic non-small cell lung cancer (NSCLC), EGFR FISH positive, candidate for a first-line platinum-based chemotherapy will be considered eligible for the trial. After evaluation of inclusion and exclusion criteria, and after signature of informed consent form, all eligible patients will be randomized to receive standard chemotherapy (control arm) or gefitinib (250 mg daily dose-experimental arm). Before, and in every case, no more than 4 weeks before study entry, all eligible patients will receive a complete disease staging, including thoracic and abdominal CT-scan, and blood sampling. Bronchoscopy will be done if not previously performed. Bone scan and brain CT-scan will be performed only if clinically indicated. Disease assessment will be performed every 6 weeks (every 2 cycles) for the first 6 cycles, and thereafter every 3 months, with a confirmatory evaluation in all patients with response or disease stabilization no less than 4 weeks after the response assessment, according to RECIST Criteria. A complete disease staging, including the above mentioned procedures, will be performed in case of progressive disease, and, in every cases, when patient withdrawals the trial. Following completion of protocol therapy, patients will be followed every 3 months.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Gefitinib, Platinum
- Keywords
- QUALITY OF LIFE
- 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
Gefitinib 250 mg/day
PlatinumDrug
Platinum based chemotherapy with cycles every 21 days
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Gefitinib Receives: Drug: Gefitinib |
| B | Active comparator | Platinum based chemotherapy Receives: Drug: Platinum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (FACT-L Total Score)
Measured: EVERY 3 WEEKS
Secondary outcomes (1)
Time to disease progression (TTP), Objective Response Rate (ORR), overall survival (OS), and tolerability.
Measured: every two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2009
- Study completionOct 2010
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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Humanitas per la Ricerca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armando Santoro, MD, Principal investigator, Fondazione Humanitas per la Ricerca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807066
- Sponsor's protocol ID
- ONC-2008-001
- Acronym
- RANGE
- Status last verified
- Oct 2010
- First submitted
- 10 Dec 2008
- Last updated
- 23 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Randomized Phase III Study Comparing Gefitinib Versus Platinum-Based Chemotherapy In EGFR Fish Positive NSCLC Patients (Range)
- ClinicalTrials.gov ID
- NCT00807066
- Acronym / sponsor ID
- RANGE / ONC-2008-001
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- QUALITY OF LIFE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Fondazione Humanitas per la RicercaUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 11 Dec 2008 (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.
Patients with locally advanced (IIIB with effusion) or metastatic non-small cell lung cancer (NSCLC), EGFR FISH positive, candidate for a first-line platinum-based chemotherapy will be considered eligible for the trial. After evaluation of inclusion and exclusion criteria, and after signature of informed consent form, all eligible patients will be randomized to receive standard chemotherapy (control arm) or gefitinib (250 mg daily dose-experimental arm). Before, and in every case, no more than 4 weeks before study entry, all eligible patients will receive a complete disease staging, including thoracic and abdominal CT-scan, and blood sampling. Bronchoscopy will be done if not previously performed. Bone scan and brain CT-scan will be performed only if clinically indicated. Disease assessment will be performed every 6 weeks (every 2 cycles) for the first 6 cycles, and thereafter every 3 months, with a confirmatory evaluation in all patients with response or disease stabilization no less than 4 weeks after the response assessment, according to RECIST Criteria. A complete disease staging, including the above mentioned procedures, will be performed in case of progressive disease, and, in every cases, when patient withdrawals the trial. Following completion of protocol therapy, patients will be followed every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: GefitinibGefitinib |
| B | Active comparator | Drug: PlatinumPlatinum based chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with locally advanced or metastatic NSCLC, EGFR FISH positive, candidate for a first-line platinum-based chemotherapy
- Histologically confirmed diagnosis of non-squamous NSCLC. Availability of tumor tissue for EGFR FISH analysis is mandatory
- Stage IIIB (with effusion) or stage IV or disease relapsed after surgery or radiotherapy and in any case not suitable for radiotherapy or surgery with curative intent
- EGFR FISH positive
- Presence of at least one measurable/evaluable not previously irradiated lesion according to RECIST criteria. Previously irradiated lesion(s) are allowed only if progressing
Key exclusion criteria (18 listed)
- EGFR FISH negative tumor
- Squamous-cell carcinoma, presence of neuroendocrine features or small cell carcinoma histology
- Impossibility to ascertain EGFR FISH status
- Concomitant radiotherapy
- Less than 30 days since completion of prior wide field chest radiotherapy or persistence of any radiotherapy related toxicity.
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 |
|---|---|---|
| GefitinibGefitinib 250 mg/day | Drug | A |
| PlatinumPlatinum based chemotherapy with cycles every 21 days | Drug | B |
Primary outcome
Quality of life (FACT-L Total Score)
Time frame: EVERY 3 WEEKS
1 secondary outcome
Time to disease progression (TTP), Objective Response Rate (ORR), overall survival (OS), and tolerability.
Time frame: every two months
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 Apr 2012.
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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.
Armando Santoro, MD principal investigator
Fondazione Humanitas per la Ricerca
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 Platinum in people with Non Small Cell Lung Cancer, run by Fondazione Humanitas per la Ricerca at 1 site in Italy.
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 11 inclusion and 18 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 Apr 2012. 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 Italy. 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?
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?
Quality of life (FACT-L Total Score) (time frame: EVERY 3 WEEKS). 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 Apr 2012.