Trial · NCT01646125
An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations
NCT01646125, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2017-03-13
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations. Trials, record NCT01646125. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01646125
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations
- NCT number
- NCT01646125
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 59 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Advanced Non Small Cell Lung Cancer (NSCLC)
- Interventions
- AUY922, Docetaxel, Pemetrexed
- First posted
- 2012-07-20
- Last updated
- 2019-07-24
- Other registries' IDs
- eudract:2012-001050-25
- Results first posted
- 2017-03-13
- Limitations and caveats
The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results to terminate the study early due to futility, data was not collected for this assessment on many of the secondary endpoints.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | 16 months | Compared PFS between the treatment of AUY922 to comparators Pemetrexed or Docetaxel. Progression-free survival (PFS) based on local investigator assessment per RECIST 1.1 was the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Progression was 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 Response Rate (ORR) | 16 months | ORR was to be compared between treatment arms. The ORR was to be based on local investigator assessment per Response Evaluation Criteria In Solid Tumors Criteria 1.1 (RECIST 1.1). Per this criteria for target lesions and assessed by MRI: 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.This outcome measure was originally planned to be analyzed up to 24 months. The DMC recommendation at the IA was to stop the study for futility. As a result, collection of all the efficacy assessments was stopped at that time. |
| Secondary | Overall Survival (OS) | from randomization until death up to death | OS is defined as the time from the date of randomization to date of death due to any cause. If a death has not been observed by the date of analysis cutoff, then OS was to be censored at the last known date patient was alive. |
| Secondary | Disease Control Rate (DCR) | baseline, until disease progression up to 24 months | Duration of DCR will be compared between treatment arms. The duration of DCR will be based on local investigator assessment per RECIST 1.1 |
| Secondary | Time to Response (TRR) | baseline, until disease progression up to 24 months | TTR was to compare between treatment arms. The TTR was to be based on local investigator assessment per RECIST 1.1 |
| Secondary | Duration of Response (DOR) | baseline, until disease progression up to 24 months | The DOR will be compared between treatment arms. The DOR will be based on local investigator assessment per RECIST 1.1 |
| Secondary | Rate of Adverse Events (AEs) | baseline, until disease progression up to 24 months | To evaluate safety and tolerability of AUY922 compared to chemotherapy agents pemetrexed or docetaxel. |
| Secondary | Change in Laboratory Paramenters | baseline, until disease progression up to 24 months | Changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), Dose interruptions, reductions and dose intensity. |
| Secondary | Time to Progression (TTP) | baseline, until disease progression up to 24 months | TTP will be compared between treatment arms. The TTP will be based on local investigator assessment per RECIST 1.1 |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | 16 months | Efficacy analysis set (EAS) compromised of a subset of patients in the FAS who received 2 lines of prior antineoplastic therapy consisting of a platinum-based treatment \& an EGFR TKI treatment. The DMC recommendation at Interim analysis was to stop the study for futility. As a result, collection of all efficacy assessments was stopped. | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) | 16 months | The data monitoring committee's (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time. | Participants | NUMBER |
| SECONDARY | Overall Survival (OS) | from randomization until death up to death | The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time. | ||
| SECONDARY | Disease Control Rate (DCR) | baseline, until disease progression up to 24 months | The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time. | ||
| SECONDARY | Time to Response (TRR) | baseline, until disease progression up to 24 months | The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time. | ||
| SECONDARY | Duration of Response (DOR) | baseline, until disease progression up to 24 months | The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time. | ||
| SECONDARY | Rate of Adverse Events (AEs) | baseline, until disease progression up to 24 months | The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time. | ||
| SECONDARY | Change in Laboratory Paramenters | baseline, until disease progression up to 24 months | The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time. | ||
| SECONDARY | Time to Progression (TTP) | baseline, until disease progression up to 24 months | The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time. |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | AUY922 Arm | 1.5 | 90% Confidence Interval 1.2 to 5.6 | Months | |
| Progression Free Survival (PFS) | Chemotherapy Arm | 2.3 | 90% Confidence Interval 1.2 to 4.0 | Months | |
| Overall Response Rate (ORR) | AUY922 Arm | Complete Response (CR) | 0 | Participants | |
| Overall Response Rate (ORR) | Chemotherapy Arm | Complete Response (CR) | 0 | Participants | |
| Overall Response Rate (ORR) | AUY922 Arm | Partial Response (PR) | 3 | Participants | |
| Overall Response Rate (ORR) | Chemotherapy Arm | Partial Response (PR) | 2 | Participants | |
| Overall Response Rate (ORR) | AUY922 Arm | ORR (CR + PR) | 3 | Participants | |
| Overall Response Rate (ORR) | Chemotherapy Arm | ORR (CR + PR) | 2 | 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 | AUY922 Arm | 31 | |
| Overall Study | STARTED | Chemotherapy Arm | 28 | |
| Overall Study | COMPLETED | AUY922 Arm | 0 | |
| Overall Study | COMPLETED | Chemotherapy Arm | 0 | |
| Overall Study | NOT COMPLETED | AUY922 Arm | 31 | |
| Overall Study | NOT COMPLETED | Chemotherapy Arm | 28 |
Source ClinicalTrials.gov
Adverse events225
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 | ANAEMIA | Blood and lymphatic system disorders | AUY922 Arm | 5 | 29 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Chemotherapy Arm | 0 | 23 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Total | 5 | 52 | |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | AUY922 Arm | 2 | 29 | |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | Chemotherapy Arm | 1 | 23 | |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | Total | 3 | 52 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | AUY922 Arm | 0 | 29 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Chemotherapy Arm | 3 | 23 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Total | 3 | 52 | |
| other | ACCOMMODATION DISORDER | Eye disorders | AUY922 Arm | 2 | 29 |
1 to 10 of 225Source ClinicalTrials.gov
See all 225 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AUY922 Arm | ||
| Total, all-cause mortality | Chemotherapy Arm | ||
| Total, all-cause mortality | Total | ||
| Total, other adverse events | AUY922 Arm | 28 | 29 |
| Total, other adverse events | Chemotherapy Arm | 21 | 23 |
| Total, other adverse events | Total | 49 | 52 |
| Total, serious adverse events | AUY922 Arm | 10 | 29 |
| Total, serious adverse events | Chemotherapy Arm | 6 | 23 |
| Total, serious adverse events | Total | 16 | 52 |
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 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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT01646125
GET https://conductscience.org/api/trials/v1/NCT01646125/events?page=2