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Non-small-cell Lung CancerPhase 3ATTENTIONNCT01377376

A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib

A Phase 3 study testing ARQ 197 and Erlotinib in people with Non-small-cell Lung Cancer, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objective of this study is to determine if the combination regimen of ARQ 197 with erlotinib will improve overall survival (OS) compared to erlotinib monotherapy in subjects with locally advanced or metastatic non-squamous NSCLC with wild-type EGFR who have received 1 or 2 prior systemic anti-cancer… 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 and Erlotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
Not given
Where
1 siteJapan
Study dates
Jul 2011to Nov 2015
Phase
Phase 3
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

  • Male or female at least 20 years of age with life expectancy ≥ 3 months
  • Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) non-squamous NSCLC with wild-type (excluding major activating mutation (exon 19 deletion and/or exon 21 L858R mutation)) EGFR gene status confirmed by a highly sensitive PCR assay
  • Evaluable disease according to RECIST, Version 1.1
  • Received one or two prior lines of systemic anti-cancer therapy for advanced or metastatic disease, one of which must be a platinum-based therapy
  • ECOG performance status of 0 or 1
  • Demonstrate adequate bone marrow, liver, and renal functions, defined as:
  • ALT and AST ≤ 2.5 × upper limit of normal (ULN), total bilirubin ≤ 1.5 × ULN, ANC ≥1.5 × 10^9/L, platelet count ≥100 × 10^9/L, hemoglobin ≥9.0 g/dL, and serum creatinine ≤1.5 mg/dL.
  • Voluntary written informed consent form before performance of any study-specific procedures or tests

Who cannot join

  • Prior therapy with an EGFR inhibitor and/or tivantinib
  • Any systemic anti-tumor treatment for NSCLC or investigational agents within 4 weeks prior to randomization
  • Palliative radiotherapy within 2 weeks, or radiotherapy for curative intent of target lesions within 8 weeks for chest and within 4 weeks for other areas prior to randomization
  • Major surgical procedure within 4 weeks prior to randomization
  • History of cardiac disease
  • Known symptomatic brain metastases
Show all 15Show fewer
  • Need to breastfeed a child during or within 12 weeks of completing the study
  • Significant gastrointestinal disorder that could interfere with absorption of tivantinib and/or erlotinib
  • History of malignancy other than NSCLC
  • Known infection with HIV, active HBV or HCV
  • Clinically significant interstitial lung diseases detected by CT scan or prior history of such diseases
  • Psychiatric disease that could affect the informed consent process
  • Subjects who wish to have a child and who would not agree to use one or more contraceptive measures that are highly effective
  • Positive serum or urine pregnancy test in female subjects of childbearing potential
  • Any other significant co-morbid condition that, in opinion of the investigator/sub-investigator, would impair study participation or cooperation

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Study site

    Osaka

Other trials in Japan

About this study

Official title: A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer With Wild-type Epidermal Growth Factor Receptor

The primary objective of this study is to determine if the combination regimen of ARQ 197 with erlotinib will improve overall survival (OS) compared to erlotinib monotherapy in subjects with locally advanced or metastatic non-squamous NSCLC with wild-type EGFR who have received 1 or 2 prior systemic anti-cancer therapies in the Intent-to-Treat (ITT) population.

Being tested
ARQ 197 and Erlotinib, Placebo and Erlotinib
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 197 and ErlotinibDrug

    Oral twice daily administration of ARQ197 and oral once daily administration of erlotinib

  • Placebo and ErlotinibDrug

    Oral twice daily administration of placebo and oral once daily administration of erlotinib

Study groups in NCT01377376
Study groupRoleWhat they receive
ARQ 197ExperimentalARQ 197 and Erlotinib
Receives: Drug: ARQ 197 and Erlotinib
PlaceboPlacebo comparatorPlacebo and Erlotinib
Receives: Drug: Placebo and Erlotinib

What is being measured

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

  1. Overall survival

Secondary outcomes (3)

  1. Progression free survival

  2. Objective response rate

    Each assessment will be determined based on RECIST criteria version 1.1 by investigator

  3. Number of patients with adverse events

Timeline

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

  1. First posted21 Jun 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionNov 2015

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
IDs, dates and publications
ClinicalTrials.gov ID
NCT01377376
Sponsor's protocol ID
ARQ197-006
Acronym
ATTENTION
Status last verified
Dec 2016
First submitted
17 Jun 2011
Last updated
7 Dec 2016
Results posted
No

Publications

  • Yoshioka H, Azuma K, Yamamoto N, Takahashi T, Nishio M, Katakami N, Ahn MJ, Hirashima T, Maemondo M, Kim SW, Kurosaki M, Akinaga S, Park K, Tsai CM, Tamura T, Mitsudomi T, Nakagawa K. A randomized, double-blind, placebo-controlled, phase III trial of erlotinib with or without a c-Met inhibitor tivantinib (ARQ 197) in Asian patients with previously treated stage IIIB/IV nonsquamous nonsmall-cell lung cancer harboring wild-type epidermal growth factor receptor (ATTENTION study). Ann Oncol. 2015 Oct;26(10):2066-72. doi: 10.1093/annonc/mdv288. Epub 2015 Jul 7.

    PubMed 26153496

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ARQ 197 and Erlotinib 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 8 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: stopped early, as of the sponsor's last update on 7 Dec 2016. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early. Results are not available in the source record.

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?

Overall survival. 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 NCT01377376, 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 7 Dec 2016; AzTrials last refreshed its copy on 28 Oct 2026.

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