Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung Cancer

NCT01244191 | Terminated Phase 3 Results DMC

• 2 other identifiers: ARQ197-A-U3022010-022365-10
• Study Type: interventional
• Target: 1,048
• Locations: 22 countries
• Sites: 297

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.

Conditions

Non Squamous, Non-small-cell Lung Cancer

Keywords

Non squamous, non-small-cell lung cancer; Epidermal growth factor receptor; c-Met inhibitor

Outcome Measures

Primary Outcomes (1)

• 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.

  Date of randomization up to date of death, up to approximately 1 year 11 months postdose

Secondary Outcomes (7)

• 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

  Date of randomization to disease progression or death (whichever comes first), up to 1 year 11 months postdose

• 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

  Date of randomization up to date of death, up to approximately 1 year 11 months postdose

• 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

  Date of randomization to disease progression or death (whichever comes first), up to 1 year 11 months postdose

• 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

  From baseline up to disease progression or the development of unacceptable toxicity (whichever occurs first), up to 1 year 11 months postdose

• 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

  From the date of first objective response (CR or PR) or SD to date of progressive disease, up to 1 year 11 months postdose

Study Arms (2)

Tivantinib and erlotinib

EXPERIMENTAL

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

Drug: Tivantinib; Drug: Erlotinib

Placebo and erlotinib

ACTIVE COMPARATOR

Tivantinib placebo given twice a day in combination with 150 mg of erlotinib, given once a day

Drug: Placebo; Drug: Erlotinib

Interventions

Tivantinib DRUG

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

Also known as: ARQ197

Tivantinib and erlotinib

Placebo DRUG

Tivantinib Placebo tablets given twice a day

Also known as: No drug

Placebo and erlotinib

Erlotinib DRUG

Erlotinib 150 mg oral tablets, given once a day

Placebo and erlotinib; Tivantinib and erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daiichi Sankyo: lead
• ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA): collaborator

Study Sites (304)

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Tucson, Arizona, 85704, United States

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Tucson, Arizona, 85710, United States

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Tucson, Arizona, 85715, United States

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Tucson, Arizona, 85724-5024, United States

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Los Angeles, California, 90048, United States

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Oxnard, California, United States

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Rancho Mirage, California, 39800, United States

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Rancho Mirage, California, 92270, United States

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Santa Monica, California, 90404, United States

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Aurora, Colorado, 80012, United States

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Boulder, Colorado, 80303, United States

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Colorado Springs, Colorado, 80907, United States

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Colorado Springs, Colorado, 80909, United States

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Denver, Colorado, 80218, United States

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Denver, Colorado, 80220, United States

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Lakewood, Colorado, 80228, United States

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Littleton, Colorado, 80120, United States

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Lone Tree, Colorado, 80124, United States

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Longmont, Colorado, 80501, United States

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Parker, Colorado, 80138, United States

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Thornton, Colorado, 80260, United States

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Newark, Delaware, 19713, United States

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Fort Myers, Florida, 33916, United States

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Miami Beach, Florida, 33012, United States

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Pensacola, Florida, 32504, United States

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Atlanta, Georgia, 30341, United States

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Austell, Georgia, 30106, United States

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Carrollton, Georgia, 30117, United States

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Cartersville, Georgia, 30121, United States

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Douglasville, Georgia, 30134, United States

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Marietta, Georgia, 30060, United States

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Chicago, Illinois, 60637, United States

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Carmel, Indiana, 46032, United States

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Fishers, Indiana, 46037, United States

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Goshen, Indiana, 46526, United States

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Greenfield, Indiana, 46140, United States

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Indianapolis, Indiana, 46219, United States

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Indianapolis, Indiana, 46227, United States

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Indianapolis, Indiana, 48202, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Towson, Maryland, 21204, United States

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Boston, Massachusetts, 02114, United States

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Minneapolis, Minnesota, 55455, United States

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St Louis, Missouri, 63110, United States

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Grand Island, Nebraska, 68803, United States

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Omaha, Nebraska, 68198, United States

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Henderson, Nevada, 89052, United States

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Henderson, Nevada, 89074, United States

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Las Vegas, Nevada, 89128, United States

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Las Vegas, Nevada, 89148, United States

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Las Vegas, Nevada, 89169, United States

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East Orange, New Jersey, 07018, United States

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Albuquerque, New Mexico, 87131, United States

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Buffalo, New York, 14263, United States

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Goshen, New York, 10924, United States

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Latham, New York, United States

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New York, New York, 10032, United States

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The Bronx, New York, 10467, United States

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Cincinnati, Ohio, 45242, United States

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Cleveland, Ohio, 44195, United States

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Kettering, Ohio, United States

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Eugene, Oregon, 97401, United States

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Portland, Oregon, 97213, United States

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Portland, Oregon, 97225, United States

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Portland, Oregon, 97227, United States

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Portland, Oregon, 97239, United States

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Springfield, Oregon, 97477, United States

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Tualatin, Oregon, 97062, United States

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Harrisburg, Pennsylvania, 17109, United States

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Hershey, Pennsylvania, 17033-0850, United States

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Philadelphia, Pennsylvania, 19104, United States

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Columbia, South Carolina, 29120, United States

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Easley, South Carolina, 29640, United States

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Greenville, South Carolina, 29601, United States

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Greenville, South Carolina, 29605, United States

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Greenville, South Carolina, 29615, United States

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Spartanburg, South Carolina, 29307, United States

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Bartlett, Tennessee, 38138, United States

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Chattanooga, Tennessee, 37404, United States

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Germantown, Tennessee, 38138, United States

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Knoxville, Tennessee, 37909, United States

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Memphis, Tennessee, 38104, United States

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Nashville, Tennessee, 37203, United States

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Southaven, Tennessee, 38671, United States

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Austin, Texas, 78705, United States

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Austin, Texas, 78731, United States

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Austin, Texas, 78745, United States

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Austin, Texas, 78758, United States

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Cedar Park, Texas, 78731, United States

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Dallas, Texas, 75216-9982, United States

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Dallas, Texas, 75246, United States

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Fort Worth, Texas, 76104, United States

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Fort Worth, Texas, 76132, United States

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Kyle, Texas, 78640, United States

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Round Rock, Texas, 78665, United States

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Round Rock, Texas, 78681, United States

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San Marcos, Texas, 78666, United States

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Salt Lake City, Utah, 84112, United States

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Arlington, Virginia, 22205, United States

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Fairfax, Virginia, 22031, United States

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Gainesville, Virginia, 20155, United States

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Leesburg, Virginia, 20176, United States

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Midlothian, Virginia, 23112, United States

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Richmond, Virginia, 23298, United States

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Winchester, Virginia, 22601, United States

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Woodbridge, Virginia, 22191, United States

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Seattle, Washington, 98104, United States

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Vancouver, Washington, 98684, United States

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Vancouver, Washington, 98686, United States

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Yakima, Washington, 98902, United States

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Rosario, Santa Fe Province, S2000SDV, Argentina

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Buenos Aires, Argentina

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Córdoba, X5000AA1, Argentina

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San Miguel de Tucumán, Argentina

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Viedma, Argentina

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Greenslopes, Queensland, 4120, Australia

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Camperdown, Australia

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Kogarah, Australia

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Perth, Australia

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St Leonards, 2065, Australia

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Wollongong, Australia

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Woodville, Australia

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Salzburg, 5020, Austria

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Wels, A-4600, Austria

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Brasschaat, 2930, Belgium

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Brussels, Belgium

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Duffel, 2570, Belgium

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Salvador, Estado de Bahia, 41253-190, Brazil

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Rio de Janeiro, Rio de Janeiro, 20231-050, Brazil

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Passo Fundo, Rio Grande do Sul, 99010-080, Brazil

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Passo Fundo, Rio Grande do Sul, 99010-260, Brazil

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Porto Alegre, Rio Grande do Sul, 90430-090, Brazil

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Joinville, Santa Catarina, 89202050, Brazil

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Joinville, Santa Catarina, 89202, Brazil

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Ijuí, Brazil

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Porto Alegre, Brazil

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São Paulo, 01224-10, Brazil

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São Paulo, Brazil

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Edmonton, Alberta, T6G 1Z2, Canada

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Surrey, British Columbia, V3V 1Z2, Canada

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Victoria, British Columbia, V8R lC3, Canada

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Winnipeg, Manitoba, RSE 0V9, Canada

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London, Ontario, N6A 4L6, Canada

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Thunder Bay, Ontario, P7B6V4, Canada

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Toronto, Ontario, M5G 1X5, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Montreal, H2W 1S6, Canada

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Québec, G1V 4G5, Canada

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Toronto, M5G 2M9, Canada

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Santiago, 7500710, Chile

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Santiago, 7500921, Chile

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Santiago, 7520378, Chile

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Santiago, 8380455, Chile

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Ostrava, 70384, Czechia

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Pardubice, 53203, Czechia

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Prague, 12808, Czechia

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Ústí nad Labem, Czechia

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Herlev, DK-2730, Denmark

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Næstved, 4700, Denmark

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Odense, DK-5000, Denmark

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Besançon, 25000, France

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Brest, 29609, France

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Caen, 14033, France

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Grenoble, 9, France

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Lille, 59037, France

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Marseille, France

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Paris, 75013, France

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Paris, 75230, France

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Pierre-Bénite, 69495, France

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Rennes, 35033, France

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Saint-Priest-en-Jarez, France

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Strasbourg, France

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Toulouse, 31059, France

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Tours, 37044, France

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Villejuif, 94805, France

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Bad Berka, 99437, Germany

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Berlin, 10117, Germany

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Berlin, 12203, Germany

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Cologne, 51109, Germany

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Erfurt, Germany

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Essen, 45122, Germany

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Esslingen am Neckar, 73730, Germany

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Gauting, 82131, Germany

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Großhansdorf, 22927, Germany

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Halle, 06120, Germany

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Hamburg, 21075, Germany

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Hanover, 30625, Germany

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Karlsruhe, 76137, Germany

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Kassel, 34125, Germany

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Leverkusen, 51375, Germany

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Löwenstein, 74245, Germany

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Mainz, 55131, Germany

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Mannheim, 68167, Germany

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München, 80336, Germany

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München, 81925, Germany

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München, Germany

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Porta Westfalica, 32457, Germany

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Rheine, 48431, Germany

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Villingen-Schwenningen, 78050, Germany

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Deszk, H-6772, Hungary

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Gyula, H-5703, Hungary

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Mátraháza, H-3233, Hungary

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Székesfehérvár, H-8000, Hungary

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Szolnok, H-5000, Hungary

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Ancona, Italy

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Avellino, 83100, Italy

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Aviano, 33081, Italy

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Bari, 70124, Italy

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Catania, 95126, Italy

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Cremona, 26100, Italy

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Cuneo, 12100, Italy

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Florence, 50134, Italy

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Livorno, 57100, Italy

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Milan, 20162, Italy

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Modena, 41124, Italy

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Monza, 20900, Italy

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Napoli, 80131, Italy

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Novara, 28100, Italy

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Orbassano, 10043, Italy

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Padua, 35128, Italy

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Palermo, 90146, Italy

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Parma, 43126, Italy

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Perugia, 06132, Italy

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Roma, 00152, Italy

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Rozzano, 20089, Italy

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Sassari, 07100, Italy

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Sondalo, 23035, Italy

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Sora, 03039, Italy

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Torino, Italy

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Mexico City, Mexico City, Mexico

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Monterrey, Nuevo León, 64460, Mexico

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Guadalajara, 44280, Mexico

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Mexico City, Mexico

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Oaxaca City, 68000, Mexico

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Oaxaca City, 70000, Mexico

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Enschede, ER, 7513, Netherlands

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Helmond, HA, 5707, Netherlands

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Amsterdam, Netherlands

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Arequipa, Peru

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Lima, 27, Peru

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Lima, 34, Peru

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Lima, 41, Peru

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Lima, Peru

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Bystra, 43-360, Poland

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Krakow, 31302, Poland

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Lublin, Poland

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Olsztyn, 31302, Poland

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Opole, Poland

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Poznan, 60-569, Poland

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Poznan, Poland

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Prabuty, 82550, Poland

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Rzeszów, 35922, Poland

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Szczecin, 70891, Poland

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Torun, Poland

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Wałbrzych, Poland

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Cluj-Napoca, 400015, Romania

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Craiova, 200385, Romania

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Oradea, 410167, Romania

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Chelyabinsk, 454087, Russia

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Irkutsk, 664035, Russia

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Izhevsk, 426009, Russia

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Kursk, 305035, Russia

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Moscow, 115478, Russia

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Moscow, 125367, Russia

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Novosibirsk, Russia

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Pyatigorsk, 357502, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 197758, Russia

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Saint Petersburg, 198255, Russia

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Tula, 300040, Russia

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Tyumen, 625041, Russia

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Veliky Novgorod, 603081, Russia

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Barakaldo, Bilbao, 48903, Spain

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Vigo, Pontevedra, 36204, Spain

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A Coruña, 15006, Spain

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A Coruña, 15009, Spain

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Alicante, 03010, Spain

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Barcelona, 08003, Spain

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Barcelona, 08907, Spain

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Madrid, 28034, Spain

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Madrid, 28041, Spain

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Madrid, Spain

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Manresa, 08243, Spain

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Málaga, 29010, Spain

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Oviedo, 33006, Spain

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Palma de Mallorca, 07010, Spain

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Sabadell, 08208, Spain

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San Cristóbal de La Laguna, 38320, Spain

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Santiago de Compostela, 15706, Spain

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Seville, 41013, Spain

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Seville, 41700, Spain

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Valencia, 46010, Spain

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Zaragoza, 50009, Spain

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Linköping, 581 85, Sweden

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Lund, Sweden

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Guildford, Surrey, GU2 7XX, United Kingdom

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Aberdeen, AB25 2ZN, United Kingdom

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Glasgow, G12OYN, United Kingdom

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London, NW1 2PG, United Kingdom

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London, W6 9RF, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Nottingham, NG5 1PB, United Kingdom

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Sheffield, S10 2SJ, United Kingdom

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Related Publications (2)

• Scagliotti G, von Pawel J, Novello S, Ramlau R, Favaretto A, Barlesi F, Akerley W, Orlov S, Santoro A, Spigel D, Hirsh V, Shepherd FA, Sequist LV, Sandler A, Ross JS, Wang Q, von Roemeling R, Shuster D, Schwartz B. Phase III Multinational, Randomized, Double-Blind, Placebo-Controlled Study of Tivantinib (ARQ 197) Plus Erlotinib Versus Erlotinib Alone in Previously Treated Patients With Locally Advanced or Metastatic Nonsquamous Non-Small-Cell Lung Cancer. J Clin Oncol. 2015 Aug 20;33(24):2667-74. doi: 10.1200/JCO.2014.60.7317. Epub 2015 Jul 13.

  PMID: 26169611 DERIVED

• Scagliotti GV, Novello S, Schiller JH, Hirsh V, Sequist LV, Soria JC, von Pawel J, Schwartz B, Von Roemeling R, Sandler AB. Rationale and design of MARQUEE: a phase III, randomized, double-blind study of tivantinib plus erlotinib versus placebo plus erlotinib in previously treated patients with locally advanced or metastatic, nonsquamous, non-small-cell lung cancer. Clin Lung Cancer. 2012 Sep;13(5):391-5. doi: 10.1016/j.cllc.2012.01.003. Epub 2012 Mar 21.

  PMID: 22440336 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

ARQ 197; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Based on the interim OS data, the study was terminated due to the protocol-defined stopping boundary for futility being met. The study would not meet its primary endpoint of improved OS in the ITT population. There were no safety concerns.

Results Point of Contact

• Title: Contact for Clinical Trial Information
• Organization: Daiichi Sankyo

CTRinfo@dsi.com

908-992-6400

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 19, 2010
• Study Start: January 11, 2011
• Primary Completion: December 15, 2012
• Study Completion: December 15, 2012
• Last Updated: April 6, 2021
• Results First Posted: October 30, 2020

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3); CZ (4); PL (12); RO (3); ME (6); NL (3); SE (2); RU (14); AU (2); CL (4); AR (5); FR (15); BR (11); PE (5); GB (8); ES (21); HU (5); IT (25); US (111); DK (3); DE (24); CA (11)