Trial · NCT02129699
Survival imProvement in Lung cancEr iNduced by DenOsUmab theRapy
NCT02129699, Phase 3, Terminated, ETOP IBCSG Partners Foundation; results first posted 2024-04-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Survival imProvement in Lung cancEr iNduced by DenOsUmab theRapy. Trials, record NCT02129699. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02129699
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Survival imProvement in Lung cancEr iNduced by DenOsUmab theRapy
- NCT number
- NCT02129699
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 595 participants, actual
- Lead sponsor
- ETOP IBCSG Partners Foundation
- Conditions
- Lung Cancer Non-small Cell Stage IV
- Interventions
- Denosumab, None, standard chemotherapy only
- First posted
- 2014-05-02
- Last updated
- 2026-09-08
- Other registries' IDs
- eudract:2013-003156-21
- Results first posted
- 2024-04-25
- Limitations and caveats
- The study steering committee decided to close the study prematurely due to poor accrual. The primary analysis is therefore underpowered.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Overall survival was measured from the date of randomization to the date of death, whatever the cause, up to a maximum of 56 months | OS will be defined as the time from the date of randomization to the date of death, whatever the cause. The follow-up of participants still alive will be censored at the moment of last follow-up. OS will be reported for all participants in both treatment arms. |
| Secondary | Progression-free Survival (PFS) Based on RECIST 1.1 | Time from date of randomisation until objective disease progression or death, whichever occurs first, assessed up to a maximum of 56 months | Progression-free survival (PFS) is defined as time from date of randomisation until objective disease progression or death, whichever occurs first. Disease progression and its evaluation are defined based on RECIST 1.1: Progressive disease (PD); \> 20% increase in the sum of the longest diameter of target lesions, new lesions or non-equivocal progression in non-target disease. If neither event has been observed, then the patient is censored at the date of the last follow up examination. Patients with new non-lung cancer malignancy must continue to be followed for progression of the original lung cancer. Patients who discontinue treatment prior to documented disease progression, including those who initiate non-protocol therapy prior to progression, will be followed for disease progression and death. |
| Secondary | Number of Participants With Response (CR+PR) Based on RECIST 1.1 | Response of the tumour is defined according to RECIST 1.1 criteria, assessed up to 56 months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. For more details to RECIST 1.1 criteria, see https://recist.eortc.org/ |
| Secondary | Toxicity Profile of Denosumab | Assessed up to 56 months | Number of patients with serious adverse events classified according to NCI CTCAE V4. |
| Secondary | Overall Survival by Membranous RANK Expression. | Up to maximum of 56 months | Overall survival is defined as time from the date of randomisation until death from any cause. Patients who are still alive at last contact are censored at the date of last follow up. |
| Secondary | Overall Survival by Cytoplasmic RANK Expression. | up to a maximum of 56 months | Overall survival is defined as time from the date of randomisation until death from any cause. Patients who are still alive at last contact are censored at the date of last follow up. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Overall survival was measured from the date of randomization to the date of death, whatever the cause, up to a maximum of 56 months | years | MEDIAN | |
| SECONDARY | Progression-free Survival (PFS) Based on RECIST 1.1 | Time from date of randomisation until objective disease progression or death, whichever occurs first, assessed up to a maximum of 56 months | years | MEDIAN | |
| SECONDARY | Number of Participants With Response (CR+PR) Based on RECIST 1.1 | Response of the tumour is defined according to RECIST 1.1 criteria, assessed up to 56 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Toxicity Profile of Denosumab | Assessed up to 56 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival by Membranous RANK Expression. | Up to maximum of 56 months | Information on RANK(L) measurements was available for 463 patients, 229 in chemotherapy alone and 234 in chemotherapy-denosumab arm, among the total 514 patients randomized in the SPLENDOUR trial. | Months | MEDIAN |
| SECONDARY | Overall Survival by Cytoplasmic RANK Expression. | up to a maximum of 56 months | Information on RANK(L) measurements was available for 463 patients, 229 in chemotherapy alone and 234 in chemotherapy-denosumab arm, among the total 514 patients randomized in the SPLENDOUR trial. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | None, Standard Chemotherapy Only | 0.73 | 95% Confidence Interval 0.63 to 0.92 | years | |
| Overall Survival | Standard Chemotherapy + Denosumab | 0.68 | 95% Confidence Interval 0.62 to 0.87 | years | |
| Progression-free Survival (PFS) Based on RECIST 1.1 | None, Standard Chemotherapy Only | .39 | 95% Confidence Interval .34 to .44 | years | |
| Progression-free Survival (PFS) Based on RECIST 1.1 | Standard Chemotherapy + Denosumab | .39 | 95% Confidence Interval .35 to .44 | years | |
| Number of Participants With Response (CR+PR) Based on RECIST 1.1 | None, Standard Chemotherapy Only | Complete response | 1 | Participants | |
| Number of Participants With Response (CR+PR) Based on RECIST 1.1 | Standard Chemotherapy + Denosumab | Complete response | 1 | Participants | |
| Number of Participants With Response (CR+PR) Based on RECIST 1.1 | None, Standard Chemotherapy Only | Partial response | 74 | Participants | |
| Number of Participants With Response (CR+PR) Based on RECIST 1.1 | Standard Chemotherapy + Denosumab | Partial response | 78 | Participants | |
| Number of Participants With Response (CR+PR) Based on RECIST 1.1 | None, Standard Chemotherapy Only | Stable disease | 101 | Participants | |
| Number of Participants With Response (CR+PR) Based on RECIST 1.1 | Standard Chemotherapy + Denosumab | Stable disease | 87 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | None, Standard Chemotherapy Only | 255 | |
| Overall Study | STARTED | Standard Chemotherapy + Denosumab | 259 | |
| Overall Study | COMPLETED | None, Standard Chemotherapy Only | 252 | |
| Overall Study | COMPLETED | Standard Chemotherapy + Denosumab | 257 | |
| Overall Study | NOT COMPLETED | None, Standard Chemotherapy Only | 3 | |
| Overall Study | NOT COMPLETED | Standard Chemotherapy + Denosumab | 2 |
Source ClinicalTrials.gov
Adverse events1,304
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 | None, Standard Chemotherapy Only | 0 | 255 | 0 |
| other | ANEMIA | Blood and lymphatic system disorders | Standard Chemotherapy + Denosumab | 1 | 259 | 1 |
| other | FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | None, Standard Chemotherapy Only | 3 | 255 | 3 |
| other | FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | Standard Chemotherapy + Denosumab | 13 | 259 | 17 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | None, Standard Chemotherapy Only | 1 | 255 | 1 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Standard Chemotherapy + Denosumab | 0 | 259 | 0 |
| other | ACUTE CORONARY SYNDROME | Cardiac disorders | None, Standard Chemotherapy Only | 2 | 255 | 2 |
| other | ACUTE CORONARY SYNDROME | Cardiac disorders | Standard Chemotherapy + Denosumab | 0 | 259 | 0 |
| other | ASYSTOLE | Cardiac disorders | None, Standard Chemotherapy Only | 1 | 255 | 1 |
| other | ASYSTOLE | Cardiac disorders | Standard Chemotherapy + Denosumab | 0 | 259 | 0 |
1 to 10 of 1,304Source ClinicalTrials.gov
See all 1,304 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | None, Standard Chemotherapy Only | 178 | 255 |
| Total, all-cause mortality | Standard Chemotherapy + Denosumab | 177 | 259 |
| Total, other adverse events | None, Standard Chemotherapy Only | 235 | 255 |
| Total, other adverse events | Standard Chemotherapy + Denosumab | 246 | 259 |
| Total, serious adverse events | None, Standard Chemotherapy Only | 97 | 255 |
| Total, serious adverse events | Standard Chemotherapy + Denosumab | 138 | 259 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| None, Standard Chemotherapy Only vs Standard Chemotherapy + Denosumab: deaths from any cause | Trial comparisons |
| None, Standard Chemotherapy Only vs Standard Chemotherapy + Denosumab: 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/NCT02129699
GET https://conductscience.org/api/trials/v1/NCT02129699/results?page=2