18 and older, any sex, with Advanced Non Small Cell Lung Cancer (NSCLC). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression Free Survival (PFS)Primary· 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 tar
Group
Value
95% CI
AUY922 Arm
1.5
1.2 – 5.6
Chemotherapy Arm
2.3
1.2 – 4.0
Overall Response Rate (ORR)Secondary· 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
Complete Response (CR)
Group
Value
95% CI
AUY922 Arm
0
Chemotherapy Arm
0
Partial Response (PR)
Group
Value
95% CI
AUY922 Arm
3
Chemotherapy Arm
2
ORR (CR + PR)
Group
Value
95% CI
AUY922 Arm
3
Chemotherapy Arm
2
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
AUY922 Arm
Serious: 10/29 (34%)
Deaths: —
Chemotherapy Arm
Serious: 6/23 (26%)
Deaths: —
Total
Serious: 16/52 (31%)
Deaths: —
Serious adverse events (20 terms)
Reaction
System
AUY922 Arm
Chemotherapy Arm
Total
PNEUMONIA
Infections and infestations
—
—
—
ATRIAL FIBRILLATION
Cardiac disorders
—
—
—
RETINAL DEGENERATION
Eye disorders
—
—
—
VISION BLURRED
Eye disorders
—
—
—
CONSTIPATION
Gastrointestinal disorders
—
—
—
STOMATITIS
Gastrointestinal disorders
—
—
—
ASTHENIA
General disorders
—
—
—
DISCOMFORT
General disorders
—
—
—
PYREXIA
General disorders
—
—
—
SUDDEN DEATH
General disorders
—
—
—
LOCALISED INFECTION
Infections and infestations
—
—
—
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
—
—
—
URINARY TRACT INFECTION
Infections and infestations
—
—
—
FALL
Injury, poisoning and procedural complications
—
—
—
DECREASED APPETITE
Metabolism and nutrition disorders
—
—
—
ARTHRALGIA
Musculoskeletal and connective tissue disorders
—
—
—
METASTASES TO CENTRAL NERVOUS SYSTEM
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study was to determine if AUY922 had superior efficacy when compared to chemotherapy agents docetaxel or pemetrexed in patients whose tumor had EGFR mutations.
The primary purpose of this study was to compare the efficacy of AUY922, when administered i.v. on a once-weekly schedule at 70 mg/m2, versus docetaxel or pemetrexed in adult patients with advanced NSCLC, whose tumors harbored EGFR activating mutations, and had developed resistance to EGFR TKI.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 24 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01646125.