Trial · NCT01124864

A Study of AUY922 in Non-small-cell Lung Cancer Patients Who Have Received Previous Two Lines of Chemotherapy.

NCT01124864, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2016-03-02

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. A Study of AUY922 in Non-small-cell Lung Cancer Patients Who Have Received Previous Two Lines of Chemotherapy. Trials, record NCT01124864. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01124864

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of AUY922 in Non-small-cell Lung Cancer Patients Who Have Received Previous Two Lines of Chemotherapy.
NCT number: NCT01124864
Status: Completed
Phases: Phase 2
Enrollment: 153 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Non-small-cell Lung Cancer
Interventions: AUY922
First posted: 2010-05-17
Last updated: 2016-03-02
Other registries' IDs: eudract:2010-020116-11
Results first posted: 2016-03-02

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Response Assessment by Study Stratum - Per Investigator Assessment	18 weeks	The primary endpoint of the study was the investigator assessment of efficacy at 18 weeks in terms of response complete response (CR)/partial response (PR), stable disease (SD), or non clinical benefit (NCB) as assessed by response evaluation criteriain solid tumors (RECIST) version 1.0. ORR = patients with confirmed complete or partial response. Stable disease at 18 weeks = patients without response and with no assessment of progressive disease up to 18 weeks, but with an assessment of stable disease or better either within 2 weeks prior to the 18 week time point, or at the next non-missing assessment after the 18 week time point. No clinical benefit = all other patients.
Secondary	Overall Survival Rate Using Kaplan Meier Estimates - Per Investigator Radiological Review	Week 12, Week 18	Overall survival (OS) is defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient is not known to have died, survival was censored at the date of last contact.
Secondary	Progression Free Survival (PFS) Rate as Per Investigator Using Kaplan Meier Estimates - Per Investigator Radiological Review	Week 12, Week 18	Progression-free survival (PFS) is 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 did not have an event, progression-free survival was censored at the date of last adequate tumor assessment. A Novartis modified response evaluation criteria in solid tumors RECIST 1.1 criteria was applied to CT/MRI imaging data when assessing any responses to AUY922 treatment. All images were evaluated locally by the investigator. All complete or partial responses were confirmed by a second assessment at least 4 weeks later.
Secondary	Pharmacokinetics (PK) of Plasma Concentration of AUY922 and Its Metabolite BJP762: AUCinf	1 hour after infusion	Summary of PK parameters for all patients one hour post 70 mg/m2 AUY922 infusion for area under the curve infinity. There are discrepancies between sample numbers and study population because PK samples were not collected from all study subjects and thus were not analyzed.
Secondary	Pharmacokinetics (PK) of Plasma Concentration of AUY922 and Its Metabolite BJP762: AUClast	1 hour after infusion	Summary of PK parameters for all patients one hour post 70 mg/m2 AUY922 infusion for area under the curve last. There are discrepancies between sample numbers and study population because PK samples were not collected from all study subjects and thus were not analyzed.
Secondary	Pharmacokinetics (PK) of Plasma Concentration of AUY922 and Its Metabolite BJP762: Cmax	1 hour after infusion	Summary of PK parameters for all patients one hour post 70 mg/m2 AUY922 infusion for concentration max. There are discrepancies between sample numbers and study population because PK samples were not collected from all study subjects and thus were not analyzed.

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	Response Assessment by Study Stratum - Per Investigator Assessment	18 weeks	The Full Analysis Set (FAS) consisted of all patients who received at least one dose of AUY922.	Participants	NUMBER
SECONDARY	Overall Survival Rate Using Kaplan Meier Estimates - Per Investigator Radiological Review	Week 12, Week 18	The Full Analysis Set (FAS) consisted of all patients who received at least one dose of AUY922.	Percentage of participants	NUMBER
SECONDARY	Progression Free Survival (PFS) Rate as Per Investigator Using Kaplan Meier Estimates - Per Investigator Radiological Review	Week 12, Week 18	The Full Analysis Set (FAS) consisted of all patients who received at least one dose of AUY922.	Percentage of participants	NUMBER
SECONDARY	Pharmacokinetics (PK) of Plasma Concentration of AUY922 and Its Metabolite BJP762: AUCinf	1 hour after infusion	PK analysis subset - All patients who received at least one dose of AUY922 in Cycle 1 and had at least one measurable post-dose AUY922 concentration.	h*ng/mL	MEAN
SECONDARY	Pharmacokinetics (PK) of Plasma Concentration of AUY922 and Its Metabolite BJP762: AUClast	1 hour after infusion	PK analysis subset - All patients who received at least one dose of AUY922 in Cycle 1 and had at least one measurable post-dose AUY922 concentration.	h*ng/mL	MEAN
SECONDARY	Pharmacokinetics (PK) of Plasma Concentration of AUY922 and Its Metabolite BJP762: Cmax	1 hour after infusion	PK analysis subset - All patients who received at least one dose of AUY922 in Cycle 1 and had at least one measurable post-dose AUY922 concentration.	ng/mL	MEAN

Source ClinicalTrials.gov

Results by group48

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Response Assessment by Study Stratum - Per Investigator Assessment	Kras Mutant Patients	Overall respose rate (ORR)	0	Participants
Response Assessment by Study Stratum - Per Investigator Assessment	EGFR Mutant Patients	Overall respose rate (ORR)	6	Participants
Response Assessment by Study Stratum - Per Investigator Assessment	EGFR and Kras Wild Type Patients	Overall respose rate (ORR)	3	Participants
Response Assessment by Study Stratum - Per Investigator Assessment	Patients With EML4-ALK Translocation	Overall respose rate (ORR)	7	Participants
Response Assessment by Study Stratum - Per Investigator Assessment	Modified EGFR Mutant Patients	Overall respose rate (ORR)	3	Participants
Response Assessment by Study Stratum - Per Investigator Assessment	Unknown	Overall respose rate (ORR)	1	Participants
Response Assessment by Study Stratum - Per Investigator Assessment	Kras Mutant Patients	Stable disease for ≥18 weeks	2	Participants
Response Assessment by Study Stratum - Per Investigator Assessment	EGFR Mutant Patients	Stable disease for ≥18 weeks	3	Participants
Response Assessment by Study Stratum - Per Investigator Assessment	EGFR and Kras Wild Type Patients	Stable disease for ≥18 weeks	3	Participants
Response Assessment by Study Stratum - Per Investigator Assessment	Patients With EML4-ALK Translocation	Stable disease for ≥18 weeks	2	Participants

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Kras Mutant Patients	28
Overall Study	STARTED	EGFR Mutant Patients	35
Overall Study	STARTED	EGFR and Kras Wild Type Patients	34
Overall Study	STARTED	Patients With EML4-ALK Translocation	22
Overall Study	STARTED	Modified EGFR Mutant Patients	31
Overall Study	STARTED		3
Overall Study	COMPLETED	Kras Mutant Patients	0
Overall Study	COMPLETED	EGFR Mutant Patients	0
Overall Study	COMPLETED	EGFR and Kras Wild Type Patients	0
Overall Study	COMPLETED	Patients With EML4-ALK Translocation	1

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events1,074

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
other	Anaemia	Blood and lymphatic system disorders	KRAS Mutant	1	28
other	Anaemia	Blood and lymphatic system disorders	EGFR Mutant	3	35
other	Anaemia	Blood and lymphatic system disorders	KRAS and EGFR Wild Type	5	34
other	Anaemia	Blood and lymphatic system disorders	EML4-ALK Translocation	3	22
other	Anaemia	Blood and lymphatic system disorders	Modified EGFR Mutant	4	31
other	Anaemia	Blood and lymphatic system disorders		0	3
other	Lymphadenopathy	Blood and lymphatic system disorders	KRAS Mutant	0	28
other	Lymphadenopathy	Blood and lymphatic system disorders	EGFR Mutant	0	35
other	Lymphadenopathy	Blood and lymphatic system disorders	KRAS and EGFR Wild Type	2	34
other	Lymphadenopathy	Blood and lymphatic system disorders	EML4-ALK Translocation	0	22

1 to 10 of 1,074Source ClinicalTrials.gov

See all 1,074 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	KRAS Mutant
Total, all-cause mortality	EGFR Mutant
Total, all-cause mortality	KRAS and EGFR Wild Type
Total, all-cause mortality	EML4-ALK Translocation
Total, all-cause mortality	Modified EGFR Mutant
Total, all-cause mortality
Total, other adverse events	KRAS Mutant	28	28
Total, other adverse events	EGFR Mutant	35	35
Total, other adverse events	KRAS and EGFR Wild Type	33	34
Total, other adverse events	EML4-ALK Translocation	22	22

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29247830	DERIVED

Source PubMed

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.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01124864

GET https://conductscience.org/api/trials/v1/NCT01124864/results?page=2

API reference For AI assistants