Advanced Non Small Cell Lung Cancer (NSCLC)Phase 2NCT01646125
An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations
A Phase 2 study testing AUY922, Docetaxel and Pemetrexed in people with Advanced Non Small Cell Lung Cancer (NSCLC), run by Novartis Pharmaceuticals at 27 sites in 12 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Non Small Cell Lung Cancer (NSCLC)
- What is being tested?
- AUY922, Docetaxel and Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 27 sitesin 12 countries
- Study dates
- 23 Nov 2012to 4 Nov 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically or cytologically documented, locally advanced (stage IIIB who are not amenable to combined modality treatment) or recurrent or metastatic (Stage IV) non-small cell lung cancer.
- Patients must have EGFR gene mutation in their tumors. This can be source - documented by one of the following:
- Provide a pathology report that indicates the patient's tumor had EGFR activating mutation in the past.
- Or:
- Perform testing (local or central) in an archival tumor or a fresh baseline biopsy tumor tissue to show the presence of EGFR activating mutation.
- Patients must have documented clinical benefit (CR, PR, or patients with SD for 6 months or greater) on prior EGFR TKI (e.g. erlotinib or gefitinib) followed by documented progression according to RECIST.
- Patients must have received prior platinum containing treatment.
- WHO performance status of 0-1
Who cannot join
- Patients who have received more than two prior lines of antineoplastic therapy for advanced disease. Chemotherapy administered as neoadjuvant or adjuvant treatment more than six months prior to study enrollment is not considered a prior line of therapy for purposes of this study.
- Evidence of spinal cord compression or current evidence of CNS metastases. Screening CT/MRI of the brain is mandatory. Note: Patients who have been treated for CNS metastases by radiation or gamma knife surgery, who been stable for at least 2 months and have discontinued high dose corticosteroids will be eligible for protocol participation
- Prior treatment with an HSP90 inhibitor
Trial locations and contacts
27 sites in 12 countries.
27 sites in 12 countries
Italy4 sites
Novartis Investigative Site
Milan, MI, 20133
Novartis Investigative Site
Monza, MB, 20900
Novartis Investigative Site
Orbassano, TO, 10043
Novartis Investigative Site
Parma, PR, 43100
South Korea4 sites
Novartis Investigative Site
Seoul, Korea, 05505
Novartis Investigative Site
Seoul, Korea, 06351
Novartis Investigative Site
Seoul, Seocho Gu, 06591
Novartis Investigative Site
Seoul, 03722
United States3 sites
Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr.
Los Angeles, California, 90048
University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 5
Madison, Wisconsin, 53792-6164
Maryland Oncology Hematology, P.A. SC
Rockville, Maryland, 20850
France3 sites
Novartis Investigative Site
Créteil, 94000
Novartis Investigative Site
Marseille, Bouches Du Rhone, 13915
Novartis Investigative Site
Villejuif, 94805
Taiwan3 sites
Novartis Investigative Site
Kuei-Shan Chiang, Taoyuan/ Taiwan ROC, 33305
Novartis Investigative Site
Taichung, 407
Novartis Investigative Site
Taipei, 10048
Netherlands2 sites
Novartis Investigative Site
Amsterdam, 1081 HV
Novartis Investigative Site
Groningen, 9713 GZ
Norway2 sites
Novartis Investigative Site
Bergen, 5021
Novartis Investigative Site
Oslo, NO-0424
Spain2 sites
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Madrid, 28034
About this study
Official title: A Multicenter, Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations Who Have Progressed on Prior EGFR TKI Treatment
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.
- Being tested
- AUY922, Docetaxel, Pemetrexed
- Keywords
- Non-small cell lung carcinoma (NSCLC), treatment of lung cancer after first metastasis, lung cancer, lung adenocarcinoma, Squamous cell lung carcinoma, Large-cell lung carcinoma, Non small cell lung carcinoma, Non small cell lung cancer, Non-small cell lung cancer, NSCLC, Large cell lung carcinoma, Large cell lung cancer, HSP90, AUY922, Pemetrexed, Docetaxel, EGFR TKI, EGFR mutations
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUY922Drug
AUY922 was to be given by i.v. once weekly at 70 mg/m2 until disease progression, death or any other reason for discontinuation from study treatment.
DocetaxelDrug
Also called TAXOTERE
Docetaxel was to be given i.v. once every 3 weeks at 75 mg/m2 until progression or unacceptable toxicity
PemetrexedDrug
Also called ALIMTA
Pemetrexed was to be given once every 3 weeks at 500 mg/m2 until progression or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| AUY922 arm | Experimental | Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.
AUY922 was to be administered weekly. Receives: Drug: AUY922 |
| chemotherapy arm | Active comparator | Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.
Pemetrexed or docetaxel was to be was to be given once every three weeks. Receives: Drug: Docetaxel; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
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
Measured: 16 months
Secondary outcomes (8)
Overall Response Rate (ORR)
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.
Measured: 16 months
Overall Survival (OS)
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.
Measured: from randomization until death up to death
Disease Control Rate (DCR)
Duration of DCR will be compared between treatment arms. The duration of DCR will be based on local investigator assessment per RECIST 1.1
Measured: baseline, until disease progression up to 24 months
Time to Response (TRR)
TTR was to compare between treatment arms. The TTR was to be based on local investigator assessment per RECIST 1.1
Measured: baseline, until disease progression up to 24 months
Duration of Response (DOR)
The DOR will be compared between treatment arms. The DOR will be based on local investigator assessment per RECIST 1.1
Measured: baseline, until disease progression up to 24 months
Rate of Adverse Events (AEs)
To evaluate safety and tolerability of AUY922 compared to chemotherapy agents pemetrexed or docetaxel.
Measured: baseline, until disease progression up to 24 months
Change in Laboratory Paramenters
Changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), Dose interruptions, reductions and dose intensity.
Measured: baseline, until disease progression up to 24 months
Time to Progression (TTP)
TTP will be compared between treatment arms. The TTP will be based on local investigator assessment per RECIST 1.1
Measured: baseline, until disease progression up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study start23 Nov 2012
- Primary completion4 Nov 2015
- Study completion4 Nov 2015
Why it stopped: An interim analysis was conducted in May-2014. Upon review of the data, the committee recommended study termination due to futility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Non Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01646125
- Sponsor's protocol ID
- CAUY922A2207
- Other IDs
- 2012-001050-25
- Status last verified
- Jul 2019
- First submitted
- 26 Jun 2012
- Last updated
- 24 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations Who Have Progressed on Prior EGFR TKI Treatment
- ClinicalTrials.gov ID
- NCT01646125
- Acronym / sponsor ID
- CAUY922A2207
- Keywords
- Non-small cell lung carcinoma (NSCLC), treatment of lung cancer after first metastasis, lung cancer, lung adenocarcinoma, Squamous cell lung carcinoma, Large-cell lung carcinoma, Non small cell lung carcinoma, Non small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: An interim analysis was conducted in May-2014. Upon review of the data, the committee recommended study termination due to futility.
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2012 (actual)
- Primary completion
- 4 Nov 2015 (actual)
- Study completion
- 4 Nov 2015 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Posted 13 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AUY922 arm | Experimental | Drug: AUY922Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm. AUY922 was to be administered weekly. |
| chemotherapy arm | Active comparator | Drug: Docetaxel, Drug: PemetrexedParticipants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm. Pemetrexed or docetaxel was to be was to be given once every three weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with histologically or cytologically documented, locally advanced (stage IIIB who are not amenable to combined modality treatment) or recurrent or metastatic (Stage IV) non-small cell lung cancer.
- Patients must have EGFR gene mutation in their tumors. This can be source - documented by one of the following:
- Patients must have documented clinical benefit (CR, PR, or patients with SD for 6 months or greater) on prior EGFR TKI (e.g. erlotinib or gefitinib) followed by documented progression according to RECIST.
- Patients must have received prior platinum containing treatment.
- WHO performance status of 0-1
Key exclusion criteria (3 listed)
- Patients who have received more than two prior lines of antineoplastic therapy for advanced disease. Chemotherapy administered as neoadjuvant or adjuvant treatment more than six months prior to study enrollment is not considered a prior line of therapy for purposes of this study.
- Evidence of spinal cord compression or current evidence of CNS metastases. Screening CT/MRI of the brain is mandatory. Note: Patients who have been treated for CNS metastases by radiation or gamma knife surgery, who been stable for at least 2 months and have discontinued high dose corticosteroids will be eligible for protocol participation
- Prior treatment with an HSP90 inhibitor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AUY922AUY922 was to be given by i.v. once weekly at 70 mg/m2 until disease progression, death or any other reason for discontinuation from study treatment. | Drug | AUY922 arm |
| DocetaxelAlso: TAXOTEREDocetaxel was to be given i.v. once every 3 weeks at 75 mg/m2 until progression or unacceptable toxicity | Drug | chemotherapy arm |
| PemetrexedAlso: ALIMTAPemetrexed was to be given once every 3 weeks at 500 mg/m2 until progression or unacceptable toxicity | Drug | chemotherapy arm |
Primary outcome
Progression Free Survival (PFS)
Time frame: 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
8 secondary outcomes
Overall Response Rate (ORR)
Time frame: 16 months
Overall Survival (OS)
Time frame: from randomization until death up to death
Disease Control Rate (DCR)
Time frame: baseline, until disease progression up to 24 months
Time to Response (TRR)
Time frame: baseline, until disease progression up to 24 months
Duration of Response (DOR)
Time frame: baseline, until disease progression up to 24 months
Rate of Adverse Events (AEs)
Time frame: baseline, until disease progression up to 24 months
Change in Laboratory Paramenters
Time frame: baseline, until disease progression up to 24 months
Time to Progression (TTP)
Time frame: baseline, until disease progression up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
27 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AUY922, Docetaxel and Pemetrexed in people with Advanced Non Small Cell Lung Cancer (NSCLC), run by Novartis Pharmaceuticals at 27 sites in 12 countries.
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 8 inclusion and 3 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: stopped early, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Italy, South Korea, United States, France, Taiwan and 7 more countries. 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?
Yes. Results are posted in the registry (first posted 13 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression Free Survival (PFS) (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2019; AzTrials last refreshed its copy on 28 Oct 2026.