Non-Small Cell Lung Carcinoma (NSCLC)Phase 1NCT00328562
ZD1839 With Hypofractionated Radiation Therapy With an Immobilization Device for Advanced Non-Small Cell Lung Cancer
A Phase 1 study testing ZD1839 (Iressa) and Thoracic Radiotherapy in people with Non-Small Cell Lung Carcinoma (NSCLC), run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and effectiveness of Iressa when used with a short course of high dose radiation therapy in patients with lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Carcinoma (NSCLC)
- What is being tested?
- ZD1839 (Iressa) and Thoracic Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Sep 2010
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed non small cell lung cancer
- Stage IV needing radiation therapy to control symptoms
- Patients with brain metastases
- Unresectable or medically inoperable
Who cannot join
- Small cell lung cancer
- Previous thoracic radiation therapy
- Oxygen-dependent patients
- Forced expiratory volume in 1 second (FEV1) less than 1.5
- Patients with active interstitial lung disease
- Patients with underlying lung disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Phase I Study of ZD1839 (Iressa) and Hypofractionated Thoracic Radiotherapy With Stereotactic Body Frame Immobilization for Patients With Advanced Non-Small Cell Lung Cancer
The purpose of this study is to determine the safety and effectiveness of Iressa when used with a short course of high dose radiation therapy in patients with lung cancer.
Read the detailed description
To estimate treatment-related esophageal, pulmonary, hematologic, and other toxicity of patients with non-small-cell lung cancer (NSCLC) receiving ZD1839 with hypofractionated thoracic radiotherapy (RT). All estimates of toxicity rates will be presented with corresponding confidence intervals using the exact method. The method of Atkinson and Brown will be used due to the two-stage sampling; the method of Conover will be used for tumor response.
To estimate tumor response rates of this treatment regimen and identify the most effective RT dose level, defined as the level associated with the best response rate. Estimates of tumor response rates will be presented with corresponding confidence intervals using the exact method of Conover. Survival will be estimated by the Kaplan-Meier method.
- Conditions
- Non-Small Cell Lung Carcinoma (NSCLC)
- Being tested
- ZD1839 (Iressa), Thoracic Radiotherapy
- Keywords
- Advanced NSCLC, Non-Small Cell Lung Carcinoma, Stage IV NSCLC
- 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.
ZD1839 (Iressa)Drug
Thoracic RadiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Iressa and RT | Experimental | Iressa plus thoracic RT at the following dose levels:
* Level 1: 42.0 Gy in 10 fractions of 4.2 Gy
* Level 2: 50.4 Gy in 12 fractions of 4.2 Gy
* Level 3: 63.0 Gy in 15 fractions of 4.2 Gy Receives: Drug: ZD1839 (Iressa); Radiation: Thoracic Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Affected by Treatment-related Morbidities
See "Adverse Events" section for specific toxicities
Measured: Twice weekly during RT and at 1-, 2-, 3-, 4-, 5-, and 6-month points after therapy
Secondary outcomes (3)
Tumor Response
Definitions of objective tumor response
- Complete response - disappearance of all target lesions
- Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter
- Progressive disease - at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions
- Stable disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started
Measured: Baseline, 1, 3, and 5 months post-treatment
Progression-free Survival
Measured: Baseline to date of progression
Survival From Starting Gefitinib
Measured: Baseline to date of expiration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2006 (estimated)
- Study startDec 2003
- Primary completionApr 2008
- Study completionSep 2010
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 Carcinoma (NSCLC)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Maria Werner-Wasik, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328562
- Sponsor's protocol ID
- 03C.225
- Other IDs
- 2003-07, JT 1436
- Status last verified
- May 2025
- First submitted
- 19 May 2006
- Last updated
- 4 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of ZD1839 (Iressa) and Hypofractionated Thoracic Radiotherapy With Stereotactic Body Frame Immobilization for Patients With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00328562
- Acronym / sponsor ID
- 03C.225
- Conditions
- Non-Small Cell Lung Carcinoma (NSCLC)
- Keywords
- Advanced NSCLC, Non-Small Cell Lung Carcinoma, Stage IV NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Dec 2003
- Primary completion
- Apr 2008 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 22 May 2006 (estimated)
- Results
- Posted 11 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and effectiveness of Iressa when used with a short course of high dose radiation therapy in patients with lung cancer.
Detailed description
To estimate treatment-related esophageal, pulmonary, hematologic, and other toxicity of patients with non-small-cell lung cancer (NSCLC) receiving ZD1839 with hypofractionated thoracic radiotherapy (RT). All estimates of toxicity rates will be presented with corresponding confidence intervals using the exact method. The method of Atkinson and Brown will be used due to the two-stage sampling; the method of Conover will be used for tumor response.
To estimate tumor response rates of this treatment regimen and identify the most effective RT dose level, defined as the level associated with the best response rate. Estimates of tumor response rates will be presented with corresponding confidence intervals using the exact method of Conover. Survival will be estimated by the Kaplan-Meier method.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iressa and RT | Experimental | Drug: ZD1839 (Iressa), Radiation: Thoracic RadiotherapyIressa plus thoracic RT at the following dose levels: * Level 1: 42.0 Gy in 10 fractions of 4.2 Gy * Level 2: 50.4 Gy in 12 fractions of 4.2 Gy * Level 3: 63.0 Gy in 15 fractions of 4.2 Gy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed non small cell lung cancer
- Stage IV needing radiation therapy to control symptoms
- Patients with brain metastases
- Unresectable or medically inoperable
Key exclusion criteria (6 listed)
- Small cell lung cancer
- Previous thoracic radiation therapy
- Oxygen-dependent patients
- Forced expiratory volume in 1 second (FEV1) less than 1.5
- Patients with active interstitial lung disease
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 |
|---|---|---|
| ZD1839 (Iressa) | Drug | Iressa and RT |
| Thoracic Radiotherapy | Radiation | Iressa and RT |
Primary outcome
Patients Affected by Treatment-related Morbidities
Time frame: Twice weekly during RT and at 1-, 2-, 3-, 4-, 5-, and 6-month points after therapy
See "Adverse Events" section for specific toxicities
3 secondary outcomes
Tumor Response
Time frame: Baseline, 1, 3, and 5 months post-treatment
Progression-free Survival
Time frame: Baseline to date of progression
Survival From Starting Gefitinib
Time frame: Baseline to date of expiration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Kimmel Cancer Center at Thomas Jefferson UniversityLink provided by the sponsor.
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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.
Maria Werner-Wasik, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZD1839 (Iressa) and Thoracic Radiotherapy in people with Non-Small Cell Lung Carcinoma (NSCLC), run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
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 4 inclusion and 6 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 4 May 2025. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 11 Aug 2014). 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?
Patients Affected by Treatment-related Morbidities (time frame: Twice weekly during RT and at 1-, 2-, 3-, 4-, 5-, and 6-month points after therapy). 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 4 May 2025.