Trial · NCT01854034

Phase 2 Study of AUY922 in NSCLC Patients With Exon 20 Insertion Mutations in EGFR

NCT01854034, Phase 2, Completed, Massachusetts General Hospital; results first posted 2018-04-10

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Phase 2 Study of AUY922 in NSCLC Patients With Exon 20 Insertion Mutations in EGFR. Trials, record NCT01854034. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01854034

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Trial

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

Title: Phase 2 Study of AUY922 in NSCLC Patients With Exon 20 Insertion Mutations in EGFR
NCT number: NCT01854034
Status: Completed
Phases: Phase 2
Enrollment: 29 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: Non Small Cell Lung Cancer
Interventions: AUY922
First posted: 2013-05-15
Last updated: 2018-04-10
Results first posted: 2018-04-10

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Overall Response Rate	From the start of treatment until the time of disease progression, median duration of follow-up of about 3 months	The number of participants that achieved a response to treatment as assessed by Response Evaluation Criteria is Solid Tumors (RECIST). Response is defined as having achieved either a complete response (CR) or a partial response (PR). * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to \< 10 mm. * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Secondary	Median Progression Free and Overall Survival	From the start of treatment until the time or death or disease progression	Overall survival (OS) is measured from the start of treatment until the time of death. Progression free survival is measured from the start of treatment until the time of death or disease progression as assessed by RECIST. Progressive disease is defined as having at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions denotes disease progression.
Secondary	The Number of Participants With Treatment Related Serious Adverse Events	From the start of treatment until 28 days after the end of treatment	The number of participants with serious adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) that were deemed to be possibly, probably, or definitely related to study treatment as determined by the treating physician.
Secondary	Exon 20 EGFR Mutations Among Participants That Responded to Treatment	Baseline, at the time of response	The specific exon 20 epidermal growth factor receptor (EGFR) mutations among participants that achieved either a partial response or complete response as assessed by RECIST. The EGFR mutations were assessed from biopsies taken at baseline and then the baseline mutations were categorized by disease response. * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to \< 10 mm. * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Overall Response Rate	From the start of treatment until the time of disease progression, median duration of follow-up of about 3 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Median Progression Free and Overall Survival	From the start of treatment until the time or death or disease progression	Months	MEDIAN
SECONDARY	The Number of Participants With Treatment Related Serious Adverse Events	From the start of treatment until 28 days after the end of treatment	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Exon 20 EGFR Mutations Among Participants That Responded to Treatment	Baseline, at the time of response	participants	NUMBER

Source ClinicalTrials.gov

Results by group9

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

Outcome	Group	Category	Value	Spread	Units
Overall Response Rate	AUY922 Treatment Arm		5		Participants
Median Progression Free and Overall Survival	AUY922 Treatment Arm	Overall Survival	9.9	95% Confidence Interval 4.5 to 19.2	Months
Median Progression Free and Overall Survival	AUY922 Treatment Arm	Progression Free Survival	2.8	95% Confidence Interval 1.3 to 5.6	Months
The Number of Participants With Treatment Related Serious Adverse Events	AUY922 Treatment Arm		6		Participants
Exon 20 EGFR Mutations Among Participants That Responded to Treatment	AUY922 Treatment Arm	Complete Response : D770_P772dup	1		participants
Exon 20 EGFR Mutations Among Participants That Responded to Treatment	AUY922 Treatment Arm	Partial Response : N771insGF	1		participants
Exon 20 EGFR Mutations Among Participants That Responded to Treatment	AUY922 Treatment Arm	Partial Response : D770_N771insSVD	1		participants
Exon 20 EGFR Mutations Among Participants That Responded to Treatment	AUY922 Treatment Arm	Partial Response : P772_H773dupPH	1		participants
Exon 20 EGFR Mutations Among Participants That Responded to Treatment	AUY922 Treatment Arm	Partial Response : P773dup	1		participants

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	AUY922 Treatment Arm	29
Overall Study	COMPLETED	AUY922 Treatment Arm	29
Overall Study	NOT COMPLETED	AUY922 Treatment Arm	0

Source ClinicalTrials.gov

Adverse events74

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	AUY922 Treatment Arm	4	29	6
other	Alanine aminotransferase increased	Investigations	AUY922 Treatment Arm	2	29	2
other	Allergic reaction	Immune system disorders	AUY922 Treatment Arm	4	29	4
other	Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	AUY922 Treatment Arm	2	29	2
other	Anemia	Blood and lymphatic system disorders	AUY922 Treatment Arm	3	29	3
other	Anorexia	Metabolism and nutrition disorders	AUY922 Treatment Arm	9	29	11
other	Anxiety	Psychiatric disorders	AUY922 Treatment Arm	6	29	6
other	Arthritis	Musculoskeletal and connective tissue disorders	AUY922 Treatment Arm	3	29	3
other	Aspartate aminotransferase increased	Investigations	AUY922 Treatment Arm	2	29	2
other	Back pain	Musculoskeletal and connective tissue disorders	AUY922 Treatment Arm	9	29	10

1 to 10 of 74Source ClinicalTrials.gov

See all 74 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AUY922 Treatment Arm	0	29
Total, other adverse events	AUY922 Treatment Arm	29	29
Total, serious adverse events	AUY922 Treatment Arm	6	29

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30351341	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.

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/NCT01854034

GET https://conductscience.org/api/trials/v1/NCT01854034/events?page=2

API reference For AI assistants