Trial · NCT01822496
Erlotinib Hydrochloride or Crizotinib and Chemoradiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
NCT01822496, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2019-08-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Erlotinib Hydrochloride or Crizotinib and Chemoradiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer. Trials, record NCT01822496. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01822496
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Erlotinib Hydrochloride or Crizotinib and Chemoradiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
- NCT number
- NCT01822496
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 59 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Stage III Non-Small Cell Lung Cancer AJCC v7, Stage IIIA Non-Small Cell Lung Cancer AJCC v7, Stage IIIB Non-Small Cell Lung Cancer AJCC v7
- Interventions
- Radiation Therapy, Carboplatin, Cisplatin, Crizotinib, Erlotinib, Etoposide, Paclitaxel
- First posted
- 2013-04-02
- Last updated
- 2019-08-05
- Results first posted
- 2019-08-05
- Limitations and caveats
- This study stopped accrual early due to unmet targeted accrual goals with 59 subjects accrued out of 234 planned.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | From randomization to study termination. Maximum follow-up was 39.0 months | Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST) guideline v1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions at any location. Progression-free survival time is measured from the date of randomization to the date of first progression, death, or last known follow-up (censored). No statistical testing was done due to early study termination. |
| Secondary | Percentage of Patients With Complete or Partial Response | From randomization to study termination. Maximum follow-up was 39.0 months | Per the RECIST guideline v1.1 complete response is defined as the disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. No statistical testing was done due to early study termination. |
| Secondary | Number of Patients With Grade 3-5 Adverse Events | From randomization to study termination. Maximum follow-up was 39.0 months | Adverse events (AE) are graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. |
| Secondary | Overall Survival | From randomization to study termination. Maximum follow-up was 39.0 months | Overall survival time is defined as time from randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. |
| Secondary | Local-regional Progression-free Survival | From randomization to study termination. Maximum follow-up was 39.0 months | Progression is defined using the RECIST guideline v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new regional lesions. Local progression is defined as progression within the planning target volume (PTV). Regional progression is defined as progression outside of the PTV but within the same lobe of the lung as the primary tumor or in regional lymph nodes as defined by the American Joint Committee on Cancer (AJCC) 7th edition nodal stations. Local-regional progression-free survival time is measured from the date of randomization to the date of first local-regional progression, death, or last known follow-up (censored). Local-regional progression-free survival rates are estimated using the Kaplan-Meier method. No testing was done due to early study termination. |
| Secondary | Distant Progression-free Survival | From randomization to study termination. Maximum follow-up was 39.0 months | Distant progression is defined as the first occurrence of distant metastasis. Distant progression-free survival time is measured from the date of randomization to the date of first distant progression, death, or last known follow-up (censored). Distant progression-free survival rates are estimated using the Kaplan-Meier method. No testing was done due to early study termination. |
| Secondary | Correlation Between Clinical Outcomes and Tumor Molecular Aberrations | Baseline |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival | From randomization to study termination. Maximum follow-up was 39.0 months | Eligible patients | months | MEDIAN |
| SECONDARY | Percentage of Patients With Complete or Partial Response | From randomization to study termination. Maximum follow-up was 39.0 months | Eligible patients with disease assessment | percentage of participants | NUMBER |
| SECONDARY | Number of Patients With Grade 3-5 Adverse Events | From randomization to study termination. Maximum follow-up was 39.0 months | Eligible patients who started study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | From randomization to study termination. Maximum follow-up was 39.0 months | Eligible patients | Months | MEDIAN |
| SECONDARY | Local-regional Progression-free Survival | From randomization to study termination. Maximum follow-up was 39.0 months | Eligible patients | Months | MEDIAN |
| SECONDARY | Distant Progression-free Survival | From randomization to study termination. Maximum follow-up was 39.0 months | Eligible patients | Months | MEDIAN |
| SECONDARY | Correlation Between Clinical Outcomes and Tumor Molecular Aberrations | Baseline | The data required for this analysis was not obtained and will not be obtained. |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival | EGFR: Erlotinib | 21.1 | 95% Confidence Interval 8.5 to NA | months | |
| Progression-free Survival | EGFR: No Erlotinib | 9.2 | 95% Confidence Interval 8.7 to NA | months | |
| Progression-free Survival | ALK: Crizotinib | 14.7 | 95% Confidence Interval 6.4 to 19.5 | months | |
| Progression-free Survival | ALK: No Crizotinib | NA | 95% Confidence Interval NA to NA | months | |
| Percentage of Patients With Complete or Partial Response | EGFR: Erlotinib | 50.0 | 95% Confidence Interval 19.0 to 81.0 | percentage of participants | |
| Percentage of Patients With Complete or Partial Response | EGFR: No Erlotinib | 26.7 | 95% Confidence Interval 4.3 to 49.1 | percentage of participants | |
| Percentage of Patients With Complete or Partial Response | ALK: Crizotinib | 66.7 | 95% Confidence Interval 29.0 to 100.0 | percentage of participants | |
| Percentage of Patients With Complete or Partial Response | ALK: No Crizotinib | 75.0 | 95% Confidence Interval 32.6 to 100.0 | percentage of participants | |
| Number of Patients With Grade 3-5 Adverse Events | EGFR: Erlotinib | 0 | Participants | ||
| Number of Patients With Grade 3-5 Adverse Events | EGFR: No Erlotinib | 0 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | EGFR: Erlotinib | 16 | |
| Overall Study | STARTED | EGFR: No Erlotinib | 23 | |
| Overall Study | STARTED | ALK: Crizotinib | 9 | |
| Overall Study | STARTED | ALK: No Crizotinib | 11 | |
| Overall Study | Eligible | EGFR: Erlotinib | 14 | |
| Overall Study | Eligible | EGFR: No Erlotinib | 21 | |
| Overall Study | Eligible | ALK: Crizotinib | 9 | |
| Overall Study | Eligible | ALK: No Crizotinib | 7 | |
| Overall Study | Eligible With Disease Assessment | EGFR: Erlotinib | 10 | |
| Overall Study | Eligible With Disease Assessment | EGFR: No Erlotinib | 15 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events808
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 | Anemia | Blood and lymphatic system disorders | EGFR: Erlotinib | 8 | 14 | |
| other | Anemia | Blood and lymphatic system disorders | EGFR: No Erlotinib | 10 | 20 | |
| other | Anemia | Blood and lymphatic system disorders | ALK: Crizotinib | 4 | 9 | |
| other | Anemia | Blood and lymphatic system disorders | ALK: No Crizotinib | 6 | 7 | |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | EGFR: Erlotinib | 1 | 14 | |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | EGFR: No Erlotinib | 1 | 20 | |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | ALK: Crizotinib | 0 | 9 | |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | ALK: No Crizotinib | 0 | 7 | |
| other | Chest pain - cardiac | Cardiac disorders | EGFR: Erlotinib | 0 | 14 | |
| other | Chest pain - cardiac | Cardiac disorders | EGFR: No Erlotinib | 1 | 20 |
1 to 10 of 808Source ClinicalTrials.gov
See all 808 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EGFR: Erlotinib | 1 | 14 |
| Total, all-cause mortality | EGFR: No Erlotinib | 3 | 20 |
| Total, all-cause mortality | ALK: Crizotinib | 2 | 9 |
| Total, all-cause mortality | ALK: No Crizotinib | 1 | 7 |
| Total, other adverse events | EGFR: Erlotinib | 14 | 14 |
| Total, other adverse events | EGFR: No Erlotinib | 20 | 20 |
| Total, other adverse events | ALK: Crizotinib | 8 | 9 |
| Total, other adverse events | ALK: No Crizotinib | 7 | 7 |
| Total, serious adverse events | EGFR: Erlotinib | 1 | 14 |
| Total, serious adverse events | EGFR: No Erlotinib | 7 | 20 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA021661 | Radiation Therapy Oncology Group | CURRAN, WALTER J. | AMERICAN COLLEGE OF RADIOLOGY | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01822496
GET https://conductscience.org/api/trials/v1/NCT01822496/results?page=2