AzTrials
AzTrials

Non-Small Cell Lung CancerPhase 3NCT02031744

A Study of the Efficacy and Safety of MetMAb Combined With Tarceva in Patients With Met-Positive Non-Small Cell Lung Cancer

A Phase 3 study testing erlotinib [Tarceva] and Onartuzumab [MetMAb] in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 8 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This randomized, Phase III, double-blind, placebo-controlled study will evaluate the safety and efficacy of MetMAb (onartuzumab) in combination with Tarceva (erlotinib) compared with treatment with Tarceva alone in patients with incurable Met-positive non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
erlotinib [Tarceva] and Onartuzumab [MetMAb]
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
530 participants
Where
8 sitesChina
Study dates
22 Jan 2014to 6 Jan 2016
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, 18 years or older.
  • Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Histologically confirmed incurable Stage IIIB/IV NSCLC tumor.
  • Met-positive status and results of epidermal growth factor receptor (EGFR)-activating mutation testing.
  • Available tumor tissue sample or agreement to take such a sample.
  • Radiographic evidence of disease. Lesions must be outside a previous radiotherapy field if they are the sole site of disease, unless disease progression has occurred at that site since radiation.
Show all 13Show fewer
  • Prior treatment with at least one platinum-based line of treatment for locally advanced, unresectable/inoperable disease or metastatic disease, and no more than one additional line of chemotherapy treatment, defined as follows:
  • Adjuvant/neoadjuvant chemotherapy or chemoradiation counts as a line of therapy if < 12 months have elapsed between the last dose and the date of recurrence. Combined treatment with chemotherapy and radiation constitutes a single regimen; surgery is not considered a regimen.
  • Cytotoxic maintenance therapy that differs from first-line therapy is considered an additional line of therapy. However, changes in treatment due to intolerance or excessive toxicity are not considered an additional regimen.
  • The last dose of prior chemotherapy must have been given >/= 21 days prior to Day 1 (>/= 14 days for vinorelbine or other vinca alkaloids or gemcitabine).
  • Anti-cancer agents used for pleurodesis are not counted as a line of therapy.
  • Prior radiation therapy is allowed provided the patient has recovered from any toxic effects and >/= 7 days have elapsed between the last session and randomization.
  • Patients must use effective contraception throughout the trial and until 3 months after the last dose.

Who cannot join

  • More than 30 days expsoure to an EGFR inhibitor or a known EGFR-toxicity resulting in dose modifications.
  • Prior exposure to agents targeting either the HGF or MET pathway, including but not limited to crizotinib, cabozantinib, ficlatuzumab, rilotumumab, and tivantinib.
  • Pleural effusion, pericardial fluid, or ascites requiring drainage every other week or more frequently.
  • Brain metastases or spinal cord compression that were not definitively treated with surgery and/or radiation or that were previously diagnosed and treated without evidence of clinically stable disease for >/= 14 days. Patients with treated central nervous system (CNS) metastases who are asymptomatic and on a stable dose of corticosteroid for >/= 14 days prior to randomization are eligible.
  • History of another cancer in the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin cancer, stage I uterine cancer, or other cancers that are curable.
  • Life expectancy < 12 weeks.
Show all 15Show fewer
  • Radiographically visible interstitial lung disease (ILD) or a history of it. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Inadequate hematologic, biological, or organ function.
  • Significant history of cardiac disease.
  • Serious 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, including positive HIV or active hepatitis B or C infections, significant gastrointestinal abnormalities, uncontrolled diabetes.
  • Any inflammatory changes to the surface of the eye.
  • Inability to take oral medication, need for intravenous alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease.
  • Pregnant or breast-feeding women.
  • Any major surgery within 2 weeks prior to randomization.
  • Inability to understand the language(s) in which the HRQOL questionnaires are available.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites

  • The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)

    Beijing, 100071

  • Jilin Cancer Hospital

    Changchun, 130012

  • Southwest Hospital , Third Military Medical University

    Chongqing, 400038

  • Third Affiliated Hospital of Third Military Medical University

    Chongqing, 400042

  • Sun Yet-sen University Cancer Center

    Guangzhou, 510060

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Jiangsu Cancer Hospital

    Nanjing, 210009

Other trials in China

About this study

Official title: A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (MetMAb) in Combination With Erlotinib as Second- or Third-Line Treatment for Patients With MET-Positive Incurable Stage IIIB/IV Non-Small Cell Lung Cancer

This randomized, Phase III, double-blind, placebo-controlled study will evaluate the safety and efficacy of MetMAb (onartuzumab) in combination with Tarceva (erlotinib) compared with treatment with Tarceva alone in patients with incurable Met-positive non-small cell lung cancer (NSCLC). Patients will be randomized in a 2:1 ratio to receive either MetMAb + Tarceva or placebo + Tarceva. Tarceva (150 mg) will be given orally once daily, and MetMAb (15 mg/kg) will be given intravenously every 3 weeks. Treatment will continue until disease progression, unacceptable toxicity, a decision to discontinue, or death occurs. Total study length is expected to be around 36 months.

Being tested
erlotinib [Tarceva], Placebo, Onartuzumab [MetMAb]
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.

  • erlotinib [Tarceva]Drug

    150 mg oral administration once daily

  • PlaceboDrug

    15 mg/kg intravenous administration every 3 weeks

  • Onartuzumab [MetMAb]Drug

    15 mg/kg intravenous administration every 3 weeks

Study groups in NCT02031744
Study groupRoleWhat they receive
erlotinib [Tarceva] + placeboPlacebo comparatorNot described
Receives: Drug: erlotinib [Tarceva]; Drug: Placebo
erlotinib [Tarceva] + onartuzumab [MetMAb]ExperimentalNot described
Receives: Drug: erlotinib [Tarceva]; Drug: Onartuzumab [MetMAb]

What is being measured

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

  1. Overall survival (OS)

    Measured: Up to 36 months

  2. Incidence of adverse events

    Measured: Up to 33 months

Secondary outcomes (4)

  1. Progression-free survival (PFS), defined as time from randomization until progression as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death.

    Measured: Up to 36 months

  2. Overall response rate (ORR), as measured by RECIST v1.1

    Measured: Up to 36 months

  3. Health-related quality of life (HRQOL) as measured by the European Organization for the Research and Treatment of Cancer (EORTC) assessments

    Measured: Up to 33 months

  4. Incidence of anti-therapeutic antibodies against MetMAB

    Measured: Up to 33 months

Timeline

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

  1. First posted9 Jan 2014 (estimated)
  2. Study start22 Jan 2014
  3. Primary completion6 Jan 2016
  4. Study completion6 Jan 2016

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
Enrolment
530 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02031744
Sponsor's protocol ID
YO28345
Status last verified
Mar 2017
First submitted
8 Jan 2014
Last updated
14 Mar 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing erlotinib [Tarceva] and Onartuzumab [MetMAb] in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 8 sites in China.

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 13 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: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. 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 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?

Overall survival (OS) (time frame: Up to 36 months). The study lists 2 primary outcomes in all. 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 NCT02031744.

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 14 Mar 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in