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Non-small Cell Lung Cancer (NSCLC)Phase 2NSCLCNCT01922583

AUY922 in Patient With Stage IV NSCLC

A Phase 2 study testing AUY922 in people with Non-small Cell Lung Cancer (NSCLC), run by National Taiwan University Hospital at 3 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label, single-arm, multicenter phase II trial in patients with stage IV EGFR T790M, EGFR exon 20 and other uncommon, HER2, or BRAF-mutated; ALK, ROS1, or RET-rearranged NSCLC. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Non-small Cell Lung Cancer (NSCLC)
What is being tested?
AUY922
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
3 sitesTaiwan
Study dates
Jan 2014to Feb 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically proven diagnosis of stage IV NSCLC (AJCC 7th) which had been treated with one systemic therapy.
  • One of the molecular alterations as follows:
  • EGFR mutations in exon 20 T790M.
  • EGFR mutations in exon 20; in-frame duplication and/or insertion (e.g. A767_V769dupASV or H773_V774insH) or point mutations other than T790M; or other uncommon mutations.
  • HER2 mutation in exon 20; in-frame duplication and/or insertion (e.g. YVMA 776-779 ins).
  • BRAF mutation in exon 15; point mutation (e.g. V600E) or in exon 11; point mutation (e.g. G469A, D594G).
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  • ALK translocation resulting in EML4-ALK, KIF5B-ALK, or TFG-ALK fusion as determined by an ALK break apart FISH assay and defined by an increase in the distance of 5' and 3' ALK probes (split 5'-3') or the loss of the 5' probe (single 3'). Positive ALK results from other methods such as immunohistochemistry (IHC) or reverse transcriptase polymerase chain reaction testing may also be acceptable.
  • ROS1 translocation resulting in CD74-ROS1 or SLC34A2-ROS1, etc.
  • RET translocation resulting in KIF5B-RET fusion, etc.
  • Patients with brain metastases are eligible if treated and neurologically stable for at least 2 weeks and is not taking any steroid.
  • Any prior chemotherapy, targeted therapy (monoclonal antibodies), or major surgeries must have had completed at least 4 weeks before initiation of study medication. Any prior targeted therapy (tyrosine kinase inhibitors), radiotherapy or minor surgeries must have had completed at least 2 weeks before initiation of study medication. Any acute toxicity must have recovered to <=grade 1 (except for alopecia).
  • Patients must have measurable or evaluable disease as per RECIST version 1.1.
  • 20 years of age or older
  • ECOG performance status 0-2
  • Adequate organ function as defined by the following criteria:
  • Bone marrow function
  • Hemoglobin >=8.0 g/dL
  • Absolute neutrophil count (ANC) >=1500/uL
  • Platelets >=100,000/uL
  • Hepatic function
  • Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) <=3.0 x upper limit of normal (ULN) or AST and ALT <=5.0 x ULN if there is liver metastasis
  • Total serum bilirubin <=1.5 x ULN Renal function
  • Creatinine <= 1.5 x ULN or creatinine clearance >=45 mL/min
  • Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
  • Patients must use effective methods of contraception during the study period and for at least 90 days following study completion (excluding surgically sterile male patients, surgically sterile or postmenopausal female patients).

Who cannot join

  • Currently on other therapeutic clinical trials
  • Prior treatment of HSP90 inhibitors
  • Any of the following within 3 months before initiation of study medication
  • Myocardial infarction
  • Unstable angina
  • Coronary artery bypass graft
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  • Congestive heart failure NYHA functional class III or IV
  • Cerebral vascular accident
  • Transient ischemic attack
  • Uncontrolled hypertension at screening
  • Ongoing cardiac arrhythmias of NCI CTCAE grade >=2
  • Active infection requiring antibiotics
  • Pregnancy or breast feeding
  • Prior malignancy within the past 5 years (excluding non-melanoma skin cancer, cervical carcinoma in situ, superficial bladder cancer, and early prostate cancer).
  • Active hepatitis B or C; positive HIV test result.

Trial locations and contacts

3 sites in 1 country.

Taiwan3 sites

  • National Cheng Kung University Hospital

    Tainan, 70403

  • Department of Oncology, National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

About this study

Official title: A Multi-center Phase II Study of AUY922 in Patients With Stage IV Non-small Cell Lung Cancer (NSCLC) With Driver Molecular Alterations Other Than Sensitive EGFR Mutation, Who Have Progressed After One Line of Systemic Therapy

This is an open-label, single-arm, multicenter phase II trial in patients with stage IV EGFR T790M, EGFR exon 20 and other uncommon, HER2, or BRAF-mutated; ALK, ROS1, or RET-rearranged NSCLC.

Read the detailed description

Study Design:

This is an open-label, single-arm, multicenter phase II trial in patients with stage IV EGFR T790M, EGFR exon 20 and other uncommon, HER2, or BRAF-mutated; ALK, ROS1, or RET-rearranged NSCLC (n = 9 x 7)

Objectives:

Primary objective(s):

To define the objective response rate by RECIST 1.1 of AUY922 in patients with stage IV EGFR T790M, EGFR exon 20 and other uncommon, HER2, or BRAF-mutated; ALK, ROS1, or RET-rearranged NSCLC

Secondary objective(s):

(1) To define the disease control rate (complete response + partial response + stable disease >=24 weeks) of AUY922 in patients with stage IV EGFR T790M, EGFR exon 20 and other uncommon, HER2, or BRAF-mutated; ALK, ROS1, or RET-rearranged NSCLC. (2) To determine the progression-free survival of AUY922 in patients with stage IV EGFR T790M, EGFR exon 20 and other uncommon, HER2, KRAS, or BRAF-mutated; ALK, ROS1, or RET-rearranged NSCLC. (3) To determine the overall survival of AUY922 in patients with stage IV EGFR T790M, EGFR exon 20 and other uncommon, HER2, KRAS, or BRAF-mutated; ALK, ROS1, or RET-rearranged NSCLC.

Exploratory Objective(s):

To study the pharmacodynamics of circulating tumor cells and plasma proteins.

Planned number of subjects: A total of 63 patients for the first stage of this study in 1 - 3 centers in Taiwan.

Patient population:

  1. Stage IV (by AJCC 7th edition) NSCLC.
  2. EGFR T790M mutation; EGFR exon 20 and other uncommon mutation; HER2 mutation; BRAF mutation; ALK translocation; ROS1 translocation; or RET translocation in tumor samples.
  3. One line of prior systemic therapy.
Being tested
AUY922
Keywords
NSCLC, EGFR mutation
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AUY922Drug

    AUY922 will be administered via IV over 1 hour once weekly in a 21 day cycle until disease progression

Study groups in NCT01922583
Study groupRoleWhat they receive
VialExperimentalAUY922 will be administered via IV over 1 hour once weekly in a 21 day cycle until disease progression
Receives: Drug: AUY922

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

    To define the by RECIST 1.1 of AUY922 in patients with stage IV EGFR T790M, EGFR exon 20 and other uncommon, HER2, or BRAF-mutated; ALK, ROS1, or RET-rearranged NSCLC

    Measured: Patients will be followed up for 2 years(post disease progression)

Secondary outcomes (2)

  1. Efficacy, progression-free survival (PFS)

    Patients will be followed for progression-free survival (PFS) and overall survival (OS) which will be analyzed by using a Kaplan-Meier curve.

    Patients will be followed up for PFS and OS for 2 years.

    Measured: Patients will be followed up for PFS and OS for 2 years.(post disease progression)

  2. overall survival (OS)

    Patients will be followed for overall survival (OS)

    Measured: Patients will be followed up for OS for 2 years.(post disease progression)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionFeb 2017
  4. Study completionFeb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01922583
Sponsor's protocol ID
CAUY922ATW02T(201302063MIPD)
Other IDs
1020009413
Acronym
NSCLC
Status last verified
Feb 2017
First submitted
2 Aug 2013
Last updated
18 Jul 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AUY922 in people with Non-small Cell Lung Cancer (NSCLC), run by National Taiwan University Hospital at 3 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: Patients will be followed up for 2 years(post disease progression)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01922583.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.

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