Trial · NCT01404260
Intercalating and Maintenance Use of Iressa Versus Chemotherapy in Selected Advanced Non Small Cell Lung Cancer
NCT01404260, Phase 3, Completed, Guangdong Association of Clinical Trials; results first posted 2017-01-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intercalating and Maintenance Use of Iressa Versus Chemotherapy in Selected Advanced Non Small Cell Lung Cancer. Trials, record NCT01404260. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01404260
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intercalating and Maintenance Use of Iressa Versus Chemotherapy in Selected Advanced Non Small Cell Lung Cancer
- NCT number
- NCT01404260
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 219 participants, actual
- Lead sponsor
- Guangdong Association of Clinical Trials
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Gefitinib, Gemcitabine +Carboplatin
- First posted
- 2011-07-28
- Last updated
- 2017-01-27
- Results first posted
- 2017-01-27
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival | 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 . |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival | 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 | Efficacy analysis, including PFS will be based on intent to treat (ITT) population.. ITT population includes all the randomised patients who receive at least one dose of study treatment with at least one baseline data of volume of plaque and at least one data after treatment. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival | Arm A: Gefitinib+Gemcitabine +Carboplatin | 9.7 | 95% Confidence Interval 5.9 to 11.3 | months | |
| Progression Free Survival | Arm B: Gemcitabine +Carboplatin | 4.2 | 95% Confidence Interval 3.6 to 4.7 | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Gefitinib + Gemcitabine + Carboplatin | 109 | |
| Overall Study | STARTED | Arm B: Gemcitabine + Carboplatin | 110 | |
| Overall Study | COMPLETED | Arm A: Gefitinib + Gemcitabine + Carboplatin | 106 | |
| Overall Study | COMPLETED | Arm B: Gemcitabine + Carboplatin | 101 | |
| Overall Study | NOT COMPLETED | Arm A: Gefitinib + Gemcitabine + Carboplatin | 3 | |
| Overall Study | NOT COMPLETED | Arm B: Gemcitabine + Carboplatin | 9 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Arm A | 9 | 109 | 9 |
| other | Diarrhea | Gastrointestinal disorders | Arm B | 1 | 110 | 1 |
| serious | Leukopenia | Blood and lymphatic system disorders | Arm A | 14 | 109 | 17 |
| serious | Leukopenia | Blood and lymphatic system disorders | Arm B | 5 | 110 | 26 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A | ||
| Total, all-cause mortality | Arm B | ||
| Total, other adverse events | Arm A | 9 | 109 |
| Total, other adverse events | Arm B | 1 | 110 |
| Total, serious adverse events | Arm A | 14 | 109 |
| Total, serious adverse events | Arm B | 5 | 110 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm A vs Arm B: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01404260
GET https://conductscience.org/api/trials/v1/NCT01404260/registered