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A RANDOMIZED, PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF ONARTUZUMAB IN COMBINATION WITH ERLOTINIB AS FIRST-LINE TREATMENT FOR PATIENTS WITH MET-POSITIVE UNRESECTABLE STAGE IIIB OR IV NON-SMALL CELL LUNG CANCER (NSCLC) CARRYING AN ACTIVATING EGFR MUTATION


Phase 3
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

A RANDOMIZED, PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF ONARTUZUMAB IN COMBINATION WITH ERLOTINIB AS FIRST-LINE TREATMENT FOR PATIENTS WITH MET-POSITIVE UNRESECTABLE STAGE IIIB OR IV NON-SMALL CELL LUNG CANCER (NSCLC) CARRYING AN ACTIVATING EGFR MUTATION


Inclusion Criteria:



- Adult patient, >/= 18 years of age

- Histologically confirmed, unresectable Stage IIIB or IV non-small cell lung cancer
(NSCLC) Patients with stable, treated brain metastases are eligible provided there is
no evidence of progression after treatment and the patient does not require
corticosteroids or is receiving a stable dose of corticosteroids for >/=14 days prior
to randomization.

- No prior treatment for unresectable Stage IIIB or IV NSCLC

- MET-positive status

- An activating EGFR mutation (exon 19 deletion or L858R, G719X, or S768I point
mutation), as determined by the central laboratory on an adequate tissue sample

- Measurable radiographic evidence of disease according to RECIST v1.1 Lesions must be
outside a previous radiotherapy field, unless disease progression has been documented
at that site since radiation.

- ECOG performance status of 0 or 1

Exclusion Criteria:

- Prior treatment for unresectable Stage IIIB or IV NSCLC Patients who have received
adjuvant or neoadjuvant therapy for non-metastatic disease in which relapse occurred
>/= 12 months after final treatment are eligible.

Patients may have received prior radiation therapy provided they have recovered from any
toxic effects thereof and that at least 7 days (Japan: >/= 12 weeks for pulmonary
irradiation) have elapsed between the last fraction and randomization.

- Prior exposure to agents targeting either the HGF or MET pathway, including but not
limited to crizotinib, cabozantinib, ficlatuzumab, rilotumumab, and tivantinib

- Exposure to an investigational or marketed agent that can act by EGFR inhibition

- Pleural effusion, pericardial fluid, or ascites requiring drainage every other week
or more frequently

- Exon 20 insertion or the T790M point mutation in EGFR (which are activating but
confer resistance to erlotinib), as determined by the central laboratory on an
adequate tissue sample

- Brain metastasis or spinal cord compression not definitively treated with surgery
and/or radiation, or previously diagnosed and treated central nervous system (CNS)
metastases or spinal cord compression without evidence of clinically stable disease
for >/=4 days Note: Patients with treated CNS metastases who are asymptomatic and on
a stable dose of corticosteroids for >/= 14 days prior to randomization are eligible.

- History of another malignancy in the previous 5 years, unless cured by surgery alone
and continuously disease-free

- Radiographically evident interstitial lung disease , concurrent infection, or a
history of any of these conditions

- Inadequate hematologic, biochemical, and organ function

- Significant history of cardiovascular disease within 6 months prior to Cycle 1 Day 1,
or current cardiac ventricular arrhythmias requiring medication

- Serious (Grade >/= 3) active infection at the time of randomization, or other serious
underlying medical conditions that would impair the ability of the patient to receive
protocol treatment

- Any inflammatory changes of the surface of the eye

- Clinically significant gastrointestinal abnormalities, including uncontrolled
inflammatory gastrointestinal diseases

- Inability to take oral medication, need for IV alimentation, prior surgical
procedures affecting absorption, or active peptic ulcer disease

- Pregnant or lactating women

- Patients known to be HIV positive or patients with known active hepatitis B or C

- Life expectancy of < 12 weeks

- Receipt of an investigational drug within 28 days prior to initiation of study
treatment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (investigator-assessed according to RECIST v1.1)

Outcome Time Frame:

approximately 3 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

GO28758

NCT ID:

NCT01887886

Start Date:

September 2013

Completion Date:

April 2017

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Hinsdale, Illinois  60521
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Cleveland, Ohio  44195
Metairie, Louisiana  70006