Non-Small Cell Lung CancerPhase 2NCT00333294
Phase II Iressa + Irradiation Followed by Chemo in NSCLC
A Phase 2 study testing Gefitinib, Radiation therapy and Cisplatin in people with Non-Small Cell Lung Cancer, run by AstraZeneca at 4 sites in France.
Trial summary
The objective of this study is to determine wether the ZD1839 associated with a radiotherapy, before the beginning of chemotherapy is effective in the treatment of your disease and to evaluate the tolerance of these treatments. 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, Radiation therapy and Cisplatin
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 4 sitesFrance
- Study dates
- Sep 2004to Jan 2006
- Phase
- Phase 2
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
- Signed informed consent.
- 18 to 75 years inclusive.
- At least one measurable lesions histologically confirmed inoperable stage III NSCLC.
- WHO performance status of 0 to 2 inclusive.
- Adequate pulmonary function, pulmonary dose volume histogram less than or equal to 40 %.
- Life expectancy of at least 6 months.
- Using secure contraceptives precautions.
Who cannot join
- Any previous anti cancer therapy for NSCLC.
- Known severe hypersensitivity to these products
- Any evidence of clinically active interstitial lung disease
- Other co-existing malignancies, symptomatic metastases.
- Abnormal blood test
- Weight loss of over 15% in the 3 months before the start of the study.
- Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Research Site
Clermont-Ferrand
Research Site
Grenoble
Research Site
Nantes
Research SIte
Paris
About this study
Official title: A Phase II Open-Label Multicentre Study Of The Efficacy Of ZD1839 (IRESSA™) In Combination With Irradiation Followed By Chemotherapy In Patients With Inoperable Stage III Non Small Cell Lung Cancer
The objective of this study is to determine wether the ZD1839 associated with a radiotherapy, before the beginning of chemotherapy is effective in the treatment of your disease and to evaluate the tolerance of these treatments.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Gefitinib, Radiation therapy, Cisplatin, Vinorelbine
- 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
Radiation therapyProcedure or surgery
CisplatinDrug
VinorelbineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the objective response rate in patients treated with this drug
Secondary outcomes (1)
Determine the safety and toxicity of this drug in these patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2006 (estimated)
- Study startSep 2004
- Study completionJan 2006
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.
- More trials run by AstraZenecaThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca France Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333294
- Sponsor's protocol ID
- 1839IL/0530
- Status last verified
- Dec 2007
- First submitted
- 2 Jun 2006
- Last updated
- 19 Dec 2007
- Results posted
- No