Non-small-cell Lung CancerPhase 2NCT01580735
ARQ 197 Plus Erlotinib in Patient With Locally Advanced or Metastatic EGFR Mutation-positive Non-small-cell Lung Cancer
A Phase 2 study testing ARQ 197 in people with Non-small-cell Lung Cancer, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
The primary objective of this study is to examine if the combination regimen of ARQ 197 with erlotinib is active in subjects with locally advanced or metastatic NSCLC with activating mutation EGFR who progressed on EGFR-TKI monotherapy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-small-cell Lung Cancer
- What is being tested?
- ARQ 197
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- May 2012to Apr 2015
- 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 confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) NSCLC with EGFR activating mutation.
- Measurable disease and documented disease progression following the first and immediate EGFR-TKI monotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function
Who cannot join
- Prior therapy with a c-Met inhibitor.
- Any systemic anti-tumor treatment for NSCLC within 7 days prior to randomization.
- Major surgical procedure within 4 weeks prior to randomization
- Known symptomatic brain metastases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Multicenter, Open-label, Single-arm Study of ARQ 197 Plus Erlotinib in Patient With Locally Advanced or Metastatic EGFR Mutation-positive Non-small-cell Lung Cancer
The primary objective of this study is to examine if the combination regimen of ARQ 197 with erlotinib is active in subjects with locally advanced or metastatic NSCLC with activating mutation EGFR who progressed on EGFR-TKI monotherapy.
- Conditions
- Non-small-cell Lung Cancer
- Being tested
- ARQ 197
- Keywords
- NSCLC, c-MET, EGFR mutation-positive, gefitinib, erlotinib, EGFR-TKI resistance
- 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.
ARQ 197Drug
ARQ 197:360 mg bid (CYP2C19 EM) or 240mg bid (CYP2C19 PM)
erlotinib: 150 mg qd
| Study group | Role | What they receive |
|---|---|---|
| ARQ 197 | Experimental | Not described Receives: Drug: ARQ 197 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
To examine the objective response rate of ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib.
Measured: Up to 6 months
Secondary outcomes (4)
To examine the progression free survival
To examine the progression free survival of patients receiving ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib
Measured: 30 months
To examine the overall survival
To examine the overall survival of patients receiving ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib
Measured: 30 months
To examine the disease control rate
To examine the disease control rate of patients receiving ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib
Measured: 30 months
To estimate the safety profile
To estimate the safety profile of patients receiving ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580735
- Sponsor's protocol ID
- ARQ 197-007
- Other IDs
- 23-4882
- Status last verified
- Aug 2015
- First submitted
- 16 Apr 2012
- Last updated
- 18 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Azuma K, Hirashima T, Yamamoto N, Okamoto I, Takahashi T, Nishio M, Hirata T, Kubota K, Kasahara K, Hida T, Yoshioka H, Nakanishi K, Akinaga S, Nishio K, Mitsudomi T, Nakagawa K. Phase II study of erlotinib plus tivantinib (ARQ 197) in patients with locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer just after progression on EGFR-TKI, gefitinib or erlotinib. ESMO Open. 2016 Jul 21;1(4):e000063. doi: 10.1136/esmoopen-2016-000063. eCollection 2016.
PubMed 27843623
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Open-label, Single-arm Study of ARQ 197 Plus Erlotinib in Patient With Locally Advanced or Metastatic EGFR Mutation-positive Non-small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01580735
- Acronym / sponsor ID
- ARQ 197-007
- Conditions
- Non-small-cell Lung Cancer
- Keywords
- NSCLC, c-MET, EGFR mutation-positive, gefitinib, erlotinib, EGFR-TKI resistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 19 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to examine if the combination regimen of ARQ 197 with erlotinib is active in subjects with locally advanced or metastatic NSCLC with activating mutation EGFR who progressed on EGFR-TKI monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARQ 197 | Experimental | Drug: ARQ 197 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) NSCLC with EGFR activating mutation.
- Measurable disease and documented disease progression following the first and immediate EGFR-TKI monotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function
Key exclusion criteria (4 listed)
- Prior therapy with a c-Met inhibitor.
- Any systemic anti-tumor treatment for NSCLC within 7 days prior to randomization.
- Major surgical procedure within 4 weeks prior to randomization
- Known symptomatic brain metastases.
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 |
|---|---|---|
| ARQ 197ARQ 197:360 mg bid (CYP2C19 EM) or 240mg bid (CYP2C19 PM) erlotinib: 150 mg qd | Drug | ARQ 197 |
Primary outcome
Objective Response Rate
Time frame: Up to 6 months
To examine the objective response rate of ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib.
4 secondary outcomes
To examine the progression free survival
Time frame: 30 months
To examine the overall survival
Time frame: 30 months
To examine the disease control rate
Time frame: 30 months
To estimate the safety profile
Time frame: 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2015.
- Derived from this study: PubMed 27843623Azuma K, Hirashima T, Yamamoto N, Okamoto I, Takahashi T, Nishio M, Hirata T, Kubota K, Kasahara K, Hida T, Yoshioka H, Nakanishi K, Akinaga S, Nishio K, Mitsudomi T, Nakagawa K. Phase II study of erlotinib plus tivantinib (ARQ 197) in patients with locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer just after progression on EGFR-TKI, gefitinib or erlotinib. ESMO Open. 2016 Jul 21;1(4):e000063. doi: 10.1136/esmoopen-2016-000063. eCollection 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARQ 197 in people with Non-small-cell Lung Cancer, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
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 4 inclusion and 4 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 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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: Up to 6 months). 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 NCT01580735, which also lists 1 linked publication.
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 Aug 2015.