Trial · NCT02513667
Ceritinib in Combination With Stereotactic Ablative Radiation Metastatic Lung Adenocarcinoma
NCT02513667, Phase 2, Terminated, University of Texas Southwestern Medical Center; results first posted 2021-12-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ceritinib in Combination With Stereotactic Ablative Radiation Metastatic Lung Adenocarcinoma. Trials, record NCT02513667. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02513667
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ceritinib in Combination With Stereotactic Ablative Radiation Metastatic Lung Adenocarcinoma
- NCT number
- NCT02513667
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- University of Texas Southwestern Medical Center
- Conditions
- ALK-positive Non-small Cell Lung Cancer
- Interventions
- Ceritinib, Stereotactic ablative body radiation
- First posted
- 2015-07-31
- Last updated
- 2023-02-03
- Results first posted
- 2021-12-17
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 | Baseline until date of first observed disease progression or death, assessed up to 31.7 months. | Number of days until disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 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 lesions |
| Secondary | Overall Survival | at 12 months | Overall survival is the percentage of participants alive at the given time point. OS is defined as the time to death from the start of drug therapy. |
| Secondary | Time to 2nd Subsequent Stereotactic Ablative Radiation | 18 hours | After the initial SABR to persisting lesions, if new lesions appear or if existing lesions enlarge but are amenable to SABR, patients will remain on study and listed as not having progressed. Time from start of systemic therapy to first day of second course of SABR |
| Secondary | Time to 3rd Subsequent Stereotactic Ablative Radiation (SABR) | 3 months | Time from start of therapy to first day of third course of SABR was measured. |
| Secondary | Number of Patients With CR/PR/Stable Disease for 6 Months | At 6 months | Number of patients with CR/PR/stable disease for 6 months was measured by evaluating target lesions. Complete Response (CR): Disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. |
| Secondary | Number of Patients With CR/PR/Stable Disease for 12 Months | at 12 months | Number of patients with CR/PR/stable disease for 12 months was measured by evaluating target lesions. Complete Response (CR): Disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. |
| Secondary | Number of Participants With Adverse Events | up to 12 months |
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 | Baseline until date of first observed disease progression or death, assessed up to 31.7 months. | days | MEAN | |
| SECONDARY | Overall Survival | at 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to 2nd Subsequent Stereotactic Ablative Radiation | 18 hours | No patients received a second course of SABR | ||
| SECONDARY | Time to 3rd Subsequent Stereotactic Ablative Radiation (SABR) | 3 months | Data was not collected due to early termination of the study since no participant received 3rd SABR. | ||
| SECONDARY | Number of Patients With CR/PR/Stable Disease for 6 Months | At 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients With CR/PR/Stable Disease for 12 Months | at 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Adverse Events | up to 12 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival | ALK-inhibitor Naive Patients | 505 | Full Range 350 to 747 | days | |
| Progression Free Survival | Patients Recieved Prior ALK Inhibitor | 482 | Full Range 73 to 963 | days | |
| Overall Survival | ALK-inhibitor Naive Patients | 8 | Participants | ||
| Overall Survival | Patients Recieved Prior ALK Inhibitor | 5 | Participants | ||
| Number of Patients With CR/PR/Stable Disease for 6 Months | ALK-inhibitor Naive Patients | 2 | Participants | ||
| Number of Patients With CR/PR/Stable Disease for 6 Months | Patients Recieved Prior ALK Inhibitor | 1 | Participants | ||
| Number of Patients With CR/PR/Stable Disease for 12 Months | ALK-inhibitor Naive Patients | 2 | Participants | ||
| Number of Patients With CR/PR/Stable Disease for 12 Months | Patients Recieved Prior ALK Inhibitor | 2 | Participants | ||
| Number of Participants With Adverse Events | ALK-inhibitor Naive Patients | 7 | Participants | ||
| Number of Participants With Adverse Events | Patients Recieved Prior ALK Inhibitor | 5 | Participants |
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 | ALK-inhibitor Naive Patients | 8 | |
| Overall Study | STARTED | Patients Recieved Prior ALK Inhibitor | 6 | |
| Overall Study | COMPLETED | ALK-inhibitor Naive Patients | 8 | |
| Overall Study | COMPLETED | Patients Recieved Prior ALK Inhibitor | 5 | |
| Overall Study | NOT COMPLETED | ALK-inhibitor Naive Patients | 0 | |
| Overall Study | NOT COMPLETED | Patients Recieved Prior ALK Inhibitor | 1 |
Source ClinicalTrials.gov
Adverse events192
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 | Abdominal Pain | Gastrointestinal disorders | ALK-inhibitor Naive Patients | 4 | 8 | |
| other | Abdominal Pain | Gastrointestinal disorders | Patients Recieved Prior ALK Inhibitor | 3 | 5 | |
| other | Acid Reflux | Gastrointestinal disorders | ALK-inhibitor Naive Patients | 1 | 8 | 1 |
| other | Acid Reflux | Gastrointestinal disorders | Patients Recieved Prior ALK Inhibitor | 0 | 5 | 0 |
| other | Alkaline phosphatase increased | Investigations | ALK-inhibitor Naive Patients | 3 | 8 | 6 |
| other | Alkaline phosphatase increased | Investigations | Patients Recieved Prior ALK Inhibitor | 3 | 5 | 5 |
| other | Increased ALT | Investigations | ALK-inhibitor Naive Patients | 4 | 8 | 7 |
| other | Increased ALT | Investigations | Patients Recieved Prior ALK Inhibitor | 2 | 5 | 6 |
| other | Anemia | Blood and lymphatic system disorders | ALK-inhibitor Naive Patients | 0 | 8 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Patients Recieved Prior ALK Inhibitor | 1 | 5 | 1 |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ALK-inhibitor Naive Patients | 0 | 8 |
| Total, all-cause mortality | Patients Recieved Prior ALK Inhibitor | 0 | 5 |
| Total, other adverse events | ALK-inhibitor Naive Patients | 8 | 8 |
| Total, other adverse events | Patients Recieved Prior ALK Inhibitor | 5 | 5 |
| Total, serious adverse events | ALK-inhibitor Naive Patients | 1 | 8 |
| Total, serious adverse events | Patients Recieved Prior ALK Inhibitor | 2 | 5 |
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ALK-inhibitor Naive Patients vs Patients Recieved Prior ALK Inhibitor: Overall Survival | Trial comparisons |
| ALK-inhibitor Naive Patients vs Patients Recieved Prior ALK Inhibitor: Number of Participants With Adverse Events | Trial comparisons |
| ALK-inhibitor Naive Patients vs Patients Recieved Prior ALK Inhibitor: Number of Patients With CR/PR/Stable Disease for 12 Months | Trial comparisons |
| ALK-inhibitor Naive Patients vs Patients Recieved Prior ALK Inhibitor: deaths from any cause | Trial comparisons |
| ALK-inhibitor Naive Patients vs Patients Recieved Prior ALK Inhibitor: Number of Patients With CR/PR/Stable Disease for 6 Months | Trial comparisons |
| ALK-inhibitor Naive Patients vs Patients Recieved Prior ALK Inhibitor: serious adverse events | 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/NCT02513667
GET https://conductscience.org/api/trials/v1/NCT02513667/events?page=2