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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01244191




Registration number
NCT01244191
Ethics application status
Date submitted
17/11/2010
Date registered
19/11/2010
Date last updated
6/04/2021

Titles & IDs
Public title
Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung Cancer
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of ARQ197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer (NSCLC)
Secondary ID [1] 0 0
2010-022365-10
Secondary ID [2] 0 0
ARQ197-A-U302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Squamous, Non-small-cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tivantinib
Treatment: Drugs - Placebo
Treatment: Drugs - Erlotinib

Experimental: Tivantinib and erlotinib - Tivantinib 720 mg daily (360 mg twice a day) in combination with 150 mg of erlotinib, given once a day

Active Comparator: Placebo and erlotinib - Tivantinib placebo given twice a day in combination with 150 mg of erlotinib, given once a day


Treatment: Drugs: Tivantinib
Tivantinib 720 mg daily as 3 x 120 mg oral tablets given twice a day

Treatment: Drugs: Placebo
Tivantinib Placebo tablets given twice a day

Treatment: Drugs: Erlotinib
Erlotinib 150 mg oral tablets, given once a day

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer - The overall survival (OS) was defined as the time from the date of randomization to the date of death from any cause.
Timepoint [1] 0 0
Date of randomization up to date of death, up to approximately 1 year 11 months postdose
Secondary outcome [1] 0 0
Progression-free Survival Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer - Progression-free Survival (PFS) was defined as the time from the date of randomization to the date of the first objective documentation of disease progression or date of death from any cause (whichever comes first). As per the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) criteria, progression was defined as at least a 20% increase in the sum of diameters of target lesions.
Timepoint [1] 0 0
Date of randomization to disease progression or death (whichever comes first), up to 1 year 11 months postdose
Secondary outcome [2] 0 0
Overall Survival in the Epidermal Growth Factor Receptor Gene Wild-Type Subpopulation Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC - The overall survival (OS) was defined as the time from the date of randomization to the date of death from any cause.
Timepoint [2] 0 0
Date of randomization up to date of death, up to approximately 1 year 11 months postdose
Secondary outcome [3] 0 0
Progression-free Survival in the Epidermal Growth Factor Receptor (EGFR) Gene Wild-Type Subpopulation Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants Non-Squamous NSCLC - Progression-free Survival (PFS) was defined as the time from the date of randomization to the date of the first objective documentation of disease progression or date of death from any cause (whichever comes first). As per the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) criteria, progression was defined as at least a 20% increase in the sum of diameters of target lesions.
Timepoint [3] 0 0
Date of randomization to disease progression or death (whichever comes first), up to 1 year 11 months postdose
Secondary outcome [4] 0 0
Best Overall Tumor Response Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer - The best overall response was defined as the best response (in the order of confirmed complete response [CR], confirmed partial response [PR], stable disease [SD], and progressive disease [PD]) among all overall responses recorded from the start of treatment until the participant withdrew from the study. If there was no tumor assessment after the first dose of study drug, the best overall response was classified as Inevaluable. Based on RECIST v1.1, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
Timepoint [4] 0 0
From baseline up to disease progression or the development of unacceptable toxicity (whichever occurs first), up to 1 year 11 months postdose
Secondary outcome [5] 0 0
Duration of Response Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer - Duration of response was defined for participants with confirmed CR or PR as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of progressive disease. Duration of SD was defined for participants whose best response was SD as the time from the randomization date to the date of the first documentation of progressive disease.
Timepoint [5] 0 0
From the date of first objective response (CR or PR) or SD to date of progressive disease, up to 1 year 11 months postdose
Secondary outcome [6] 0 0
Treatment-Emergent Adverse Events Reported in =5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer - Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration.
Timepoint [6] 0 0
Baseline up to 30 days after last dose, up to 1 year 11 months postdose
Secondary outcome [7] 0 0
Treatment-Emergent Adverse Events Related to Tivantinib/Placebo Experienced by =5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC - Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration.
Timepoint [7] 0 0
Baseline up to 30 days after last dose, up to 1 year 11 months postdose

Eligibility
Key inclusion criteria
- Histologically or cytologically confirmed surgically unresectable locally advanced or
metastatic (stage IIIB/IV) non-squamous non-small-cell lung cancer.

- Measurable disease and documented disease progression following last prior therapy
according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, Version
1.1.

- Have received one or two prior lines of systemic anti-cancer therapy therapy for
advanced or metastatic disease, one of which must be a platinum-doublet therapy.
Patients who received only adjuvant treatment will be eligible only if disease
progression occurred <6 months after completion of adjuvant therapy. Prior maintenance
therapy is allowed and will be considered as the same line of therapy when continued
without discontinuation after initiation of a treatment regimen.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Resolution of any toxic effects of prior therapy (including radiotherapy) according to
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
(CTCAE), Version 4.0, Grade =1 (with the exception of alopecia and =grade 2
neuropathy). Subject must have recovered from significant surgery-related
complications.

- Demonstrate adequate bone marrow, liver, and renal functions, defined as:

- ALT, AST, and alkaline phosphatase = 2.5 × upper limit of normal (ULN) in subjects
with no liver metastasis and =5.0 x ULN in subjects with liver metastasis.

- Total bilirubin = 1.5 × ULN (= 4 × ULN total and =1.5 × ULN direct bilirubin is
acceptable for subjects with Gilbert's syndrome).

- ANC =1.5 × 10^9/L.

- Platelet count =100 × 10^9/L.

- Hemoglobin =9.0 g/dL (transfusion and/or growth factor support allowed).

- Serum creatinine =1.5 × ULN or creatinine clearance = 60 mL/min.

- Archival and/or fresh biopsy tissue sample must be available for biomarker
determination. The status of the following biomarkers will be collected in this study:
EGFR and KRAS mutation status prior to randomization, and MET status post
randomization

- If of child-bearing/reproductive potential (female or male), must agree to use
double-barrier contraceptive measures, oral contraception, or avoidance of intercourse
during the study and for 90 days after last investigational drug dose received

- If female and of childbearing potential, must have a negative result of a pregnancy
test (serum or urine) within 72 hours prior to initiating study treatment.

- Must have signed and dated an approved Informed Consent Form (Including HIPAA
authorization, if applicable) before performance of any study-specific procedures or
tests. Subjects must be fully informed about their illness and the investigational
nature of the study protocol (including forseeable risks and possible side effects)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior therapy with an EGFR inhibitor and/or ARQ 197 (or other known c-MET inhibitor).

- Receipt of any systemic anti-tumor treatment for NSCLC within 3 weeks prior to
randomization.

- Receipt of palliative radiotherapy within 2 weeks or radiotherapy for curative intent
of target lesions within 3 weeks prior to randomization. Lesions subjected to
radiotherapy within 3 weeks prior to randomization may not be used as target lesions.

- Major surgical procedure within 3 weeks prior to randomization.

- History of cardiac disease:

Congestive heart failure defined as Class II to IV per New York Heart Association
classification; active coronary artery disease; previously diagnosed symptomatic
bradycardia (subjects with asymptomatic bradycardia and heart rate above 50 bpm are
allowed) or other cardiac arrhythmia defined as =Grade 2 according to NCI CTCAE, version
4.0, or uncontrolled hypertension; myocardial infarction that occurred within 6 months
prior to study entry (myocardial infarction that occurred > 6 months prior to study entry
is permitted).

- Clinically unstable central nervous system (CNS) metastasis (to be enrolled in the
study, subjects must have confirmation of stable disease by MRI or computed tomography
(CT) scan within 4 weeks of randomization and have CNS metastases well controlled by
steroids, anti-epileptics or other symptom-relieving medications).

- Need to breastfeed a child during or within 12 weeks of completing the study.

- Significant gastrointestinal disorder that, in the opinion of the investigator, could
interfere with absorption of ARQ 197 and/or erlotinib (eg, Crohn's disease, small or
large bowel resection, malabsorption syndrome).

- Inability or unwillingness to swallow the complete doses of ARQ 197 or erlotinib.

- Any known contraindication to treatment with, including hypersensitivity to, ARQ 197
or erlotinib.

- History of malignancy other than NSCLC within the 5 years prior to randomization, with
the exceptions of adequately treated intraepithelial carcinoma of the cervix uteri;
prostate carcinoma with a prostate-specific antigen value <0.2 ng/mL; or basal or
squamous-cell carcinoma of the skin.

- Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or
hepatitis C virus (HCV).

- Any other significant co-morbid condition that, in opinion of the investigator, would
impair study participation or cooperation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
- Greenslopes
Recruitment hospital [2] 0 0
- Camperdown
Recruitment hospital [3] 0 0
- Kogarah
Recruitment hospital [4] 0 0
- Perth
Recruitment hospital [5] 0 0
- St. Leonards
Recruitment hospital [6] 0 0
- Wollongong
Recruitment hospital [7] 0 0
- Woodville
Recruitment postcode(s) [1] 0 0
4120 - Greenslopes
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Kogarah
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment postcode(s) [5] 0 0
2065 - St. Leonards
Recruitment postcode(s) [6] 0 0
- Wollongong
Recruitment postcode(s) [7] 0 0
- Woodville
Recruitment outside Australia
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ER
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HA
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Netherlands
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Amsterdam
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Peru
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Arequipa
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Peru
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Lima
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Bystra
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Lublin
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Opole
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Poznan
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Prabuty
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Rzeszow
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Szczecin
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Torun
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Walbrzych
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Romania
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Cluj-Napoca
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Oradea
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Moscow
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State/province [157] 0 0
Novgorod
Country [158] 0 0
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State/province [158] 0 0
Novosibirsk
Country [159] 0 0
Russian Federation
State/province [159] 0 0
Pyatigorsk
Country [160] 0 0
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State/province [160] 0 0
St Petersburg
Country [161] 0 0
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State/province [161] 0 0
St. Petersburg
Country [162] 0 0
Russian Federation
State/province [162] 0 0
Tula
Country [163] 0 0
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State/province [163] 0 0
Tyumen
Country [164] 0 0
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State/province [164] 0 0
Bilbao
Country [165] 0 0
Spain
State/province [165] 0 0
Pontevedra
Country [166] 0 0
Spain
State/province [166] 0 0
Alicante
Country [167] 0 0
Spain
State/province [167] 0 0
Barcelona
Country [168] 0 0
Spain
State/province [168] 0 0
Coruna
Country [169] 0 0
Spain
State/province [169] 0 0
La Laguna
Country [170] 0 0
Spain
State/province [170] 0 0
Madrid
Country [171] 0 0
Spain
State/province [171] 0 0
Malaga
Country [172] 0 0
Spain
State/province [172] 0 0
Manresa
Country [173] 0 0
Spain
State/province [173] 0 0
Oviedo
Country [174] 0 0
Spain
State/province [174] 0 0
Palma de Mallorca
Country [175] 0 0
Spain
State/province [175] 0 0
Sabadell
Country [176] 0 0
Spain
State/province [176] 0 0
Santiago de Compostela
Country [177] 0 0
Spain
State/province [177] 0 0
Sevilla
Country [178] 0 0
Spain
State/province [178] 0 0
Valencia
Country [179] 0 0
Spain
State/province [179] 0 0
Zaragoza
Country [180] 0 0
Sweden
State/province [180] 0 0
Linkoping
Country [181] 0 0
Sweden
State/province [181] 0 0
Lund
Country [182] 0 0
United Kingdom
State/province [182] 0 0
Surrey
Country [183] 0 0
United Kingdom
State/province [183] 0 0
Aberdeen
Country [184] 0 0
United Kingdom
State/province [184] 0 0
Glasgow
Country [185] 0 0
United Kingdom
State/province [185] 0 0
London
Country [186] 0 0
United Kingdom
State/province [186] 0 0
Manchester
Country [187] 0 0
United Kingdom
State/province [187] 0 0
Nottingham
Country [188] 0 0
United Kingdom
State/province [188] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Daiichi Sankyo, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study is to determine if the combination regimen of tivantinib with erlotinib will
improve overall survival relative to erlotinib alone in subjects with locally advanced or
metastatic non-squamous, non-small cell lung cancer who have received 1 or 2 prior systemic
anti-cancer therapies.
Trial website
https://clinicaltrials.gov/show/NCT01244191
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Leader
Address 0 0
Daiichi Sankyo, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01244191