A Phase 1 interventional study of ZD1839 (Iressa) and Thoracic Radiotherapy in Non-Small Cell Lung Carcinoma (NSCLC), sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University · Phase 1, Interventional, and Treatment
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.
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 13 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Sidney Kimmel Cancer Center at Thomas Jefferson University is the lead sponsor of 125 studies on the registry; none are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 7 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: ZD1839 (Iressa) · Radiation: Thoracic Radiotherapy
Patients Affected by Treatment-related Morbidities
See "Adverse Events" section for specific toxicities
Time frame: Twice weekly during RT and at 1-, 2-, 3-, 4-, 5-, and 6-month points after therapy
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
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
| Milestone | Iressa and RT |
|---|---|
| Started | 13 |
| Completed | 12 |
| Not completed | 1 |
| Withdrew: Disease progression | 1 |
See "Adverse Events" section for specific toxicities
| participants | Iressa and RT |
|---|---|
| Patients Affected by Treatment-related Morbidities | 12 |
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
| participants | Iressa and RT |
|---|---|
| Complete response | 3 |
| Partial response | 1 |
| Minor response | 3 |
| Stable disease | 1 |
| Progressive disease | 1 |
| Not evaluable | 3 |
| months | Iressa and RT |
|---|---|
| Progression-free Survival | 5 (2 to 11) |
| months | Iressa and RT |
|---|---|
| Survival From Starting Gefitinib | 10 (1 to 26) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Iressa and RT | — | 5/12 (41.7%) | 12/12 (100%) |
| Event | Iressa and RT |
|---|---|
| DeathGeneral disorders | 5/12 |
| Event | Iressa and RT |
|---|---|
| DiarrheaGeneral disorders | 5/12 |
| DysphagiaGeneral disorders | 4/12 |
| RashSkin and subcutaneous tissue disorders | 4/12 |
| CoughGeneral disorders | 3/12 |
| NauseaGeneral disorders | 3/12 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 3/12 |
| Decreased hemoglobinBlood and lymphatic system disorders | 3/12 |
| FatigueGeneral disorders | 2/12 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/12 |
| Decreased whole blood countBlood and lymphatic system disorders | 2/12 |
| Age, Continuous(years) | Iressa and RT |
|---|---|
| Mean | 68.75 ± 13.24 |
| Age, Categorical(Participants) | Iressa and RT |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 8 |
| Sex: Female, Male(Participants) | Iressa and RT |
|---|---|
| Female | 8 |
| Male | 5 |
| Race (NIH/OMB)(Participants) | Iressa and RT |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 10 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Ethnicity (NIH/OMB)(Participants) | Iressa and RT |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 12 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Iressa and RT |
|---|---|
| United States | 13 |
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Sidney Kimmel Cancer Center at Thomas Jefferson University