AzTrials
AzTrials

Non-Small Cell Lung CancerPhase 2NCT00600015

Sorafenib/Erlotinib Versus Erlotinib Alone in Previously Treated Advanced Non-Small-Cell Lung Cancer (NSCLC)

A Phase 2 study testing Erlotinib + Sorafenib in people with Non-Small Cell Lung Cancer, run by SCRI Development Innovations, LLC at 16 sites in United States.

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 trial will investigate the use of the newer targeted agents erlotinib and sorafenib in patients with stage IIIB or stage IV NSCLC who have received 1-2 prior chemotherapy regimens. 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 + Sorafenib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
166 participants
Where
16 sitesUnited States
Study dates
Feb 2008to Feb 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologically confirmed locally advanced or metastatic NSCLC (unresectable stage IIIB or stage IV). Eligible histologies include adenocarcinoma and squamous cell carcinoma. Patients with recurrent disease after treatment for localized NSCLC are also eligible. Cytologic specimens obtained by brushings, washings, or needle aspiration are acceptable.
  • At least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques, or as >= 10 mm with spiral computerized tomography (CT) scan according to the Response Evaluation Criteria in Solid Tumors (RECIST).
  • Failure of at least one, and no more than two prior cytotoxic chemotherapy regimens for advanced disease (either due to progressive disease or toxicity).
  • Recovery from any toxic effects of prior therapy to <= grade 1.
  • Completion of radiation therapy at least 28 days prior to the start of study treatment (not including palliative local radiation). Previously irradiated lesions in the advanced setting cannot be included as target lesions unless clear tumor progression has been observed since the end of radiation.
  • An ECOG performance status of 0-2.
Show all 13Show fewer
  • Absolute neutrophil count (ANC) >= 1,500, platelets >= 75,000.
  • Hemoglobin >= 9 g/dL (within 7 days prior to study treatment).
  • International normalized ratio (INR) <= 1.5 or prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (WNL) of the institution
  • Serum creatinine <= 1.5 x institutional upper limit of normal (ULN) within 7 days prior to study treatment.
  • Transaminases <= 3 x institutional ULN
  • Agreement of female patients of childbearing potential and male patients who have partners of childbearing potential to use an effective form of contraception to prevent pregnancy during treatment, and for a minimum of 90 days thereafter.
  • Patients who have treated brain metastases >= 4 weeks out (with surgery and/or radiation therapy) and no evidence of CNS progression.

Who cannot join

  • Past or current history of neoplasm (other than the entry diagnosis), with the exception of treated non-melanoma skin cancer or carcinoma in-situ of the cervix, or other cancers cured by local therapy alone, and a disease-free survival (DFS) >= 3 years.
  • Patients who have mixed tumors with small-cell elements are ineligible.
  • Pregnancy or lactation.
  • Prior treatment with EGFR TKIs or VEGFR TKIs for NSCLC. [NOTE: prior cetuximab and/or bevacizumab use is permitted].
  • Significant cardiac disease within 90 days of starting study treatment
  • Myocardial infarction within 6 months prior to initiation of study treatment.
Show all 19Show fewer
  • Cardiomegaly on chest imaging or ventricular hypertrophy on electrocardiogram (ECG)
  • Poorly controlled hypertension
  • Unstable angina (anginal symptoms at rest).
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  • Presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia.
  • A serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
  • A major surgical procedure, open biopsy, or significant traumatic injury within 28 days of beginning treatment, or anticipation of the need for major surgery during the course of the study.
  • Stroke or transient ischemic attack (TIA) within the past 6 months.
  • Any prior history of hypertensive crisis or hypertensive encephalopathy.
  • Pulmonary hemorrhage/bleeding event >= grade 2 within 28 days of study treatment.
  • Any other non-pulmonary hemorrhage/bleeding event >= grade 3 within 28 days of study treatment.
  • Evidence or history of bleeding diathesis or coagulopathy.
  • Serious non-healing wound, ulcer, or bone fracture.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Cancer Care of Western North Carolina

    Asheville, North Carolina, 28801

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • Chattanooga Oncology Hematology Associates

    Chattanooga, Tennessee, 37404

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • Family Cancer Center

    Collierville, Tennessee, 38017

  • South Carolina Oncology Associates, PA

    Columbia, South Carolina, 29210

  • Mid Ohio Oncology/Hematology, Inc./ The Mark H. Zangmeister Center

    Columbus, Ohio, 43219

  • Coastal Bend Cancer Center

    Corpus Christi, Texas, 78463

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • Wellstar Cancer Research

    Marietta, Georgia, 30060

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37023

  • Methodist Cancer Center

    Omaha, Nebraska, 68114

  • Kansas City Cancer Centers

    Overland Park, Kansas, 66210

  • Virginia Cancer Institute

    Richmond, Virginia, 23235

Other trials in United States

About this study

Official title: A Randomized Double-Blind Placebo-Controlled Phase II Trial of Sorafenib and Erlotinib or Erlotinib Alone in Previously Treated Advanced Non-Small Cell Lung Cancer

This trial will investigate the use of the newer targeted agents erlotinib and sorafenib in patients with stage IIIB or stage IV NSCLC who have received 1-2 prior chemotherapy regimens. Patients will be randomized to receive erlotinib (150 mg/day) and sorafenib (400 mg twice daily), or erlotinib (150 mg/day) and a placebo.

Read the detailed description

The rationale of this study is to combine two distinct kinase inhibitors to evaluate synergistic inhibition of angiogenesis and epidermal growth factor receptor (EGFR) signaling. Erlotinib is a oral tyrosine kinase inhibitor that targets EGFR. Sorafenib is a oral tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor (VEGFR), platelet derived growth factor receptor beta, Raf-1, Flt-3, and C-kit. These agents also do not exhibit overlapping adverse event profiles which provided additional support for studying this combination therapy.

Being tested
Erlotinib + Sorafenib, Erlotinib + Placebo
Keywords
Non-Small Cell Lung Cancer, Advanced, Sorafenib, Erlotinib, Double-blind, Placebo-controlled
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 + SorafenibDrug

    Also called Tarceva, Nexavar

    Patients who are randomized to Cohort A will take sorafenib 400 mg (2 x 200-mg tablets) orally twice a day, and erlotinib 150 mg orally once a day.

  • Erlotinib + PlaceboDrug

    Also called Tarceva

    Patients who are randomized to Cohort B will take erlotinib 150 mg orally once a day and placebo orally twice a day.

Study groups in NCT00600015
Study groupRoleWhat they receive
Combination TherapyExperimentalErlotinib + Sorafenib
Receives: Drug: Erlotinib + Sorafenib
PlaceboPlacebo comparatorErlotinib + Placebo
Receives: Drug: Erlotinib + Placebo

What is being measured

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

  1. Overall Objective Response Rate (ORR)

    Overall response rate (ORR) is defined as the percentage of patients who have a partial or complete response to therapy. Responses were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.0).

    Complete Response: Disappearance of all target lesions, and disappearance of all non-target lesions.

    Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions (taking as reference the baseline sum of longest diameters)

    Measured: 18 months

  2. Progression Free Survival (PFS)

    Progression-free survival is defined as the time from the first day of treatment until the day tumor progression was documented. Response was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST).

    Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

    Measured: 18 months

  3. Disease Control Rate (DCR)

    Disease Control Rate (DCR) is defined as the percentage of patients who have a partial/complete/stable response to therapy. Responses were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.0).

    Complete Response: Disappearance of all target lesions, and disappearance of all non-target lesions.

    Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions (taking as reference the baseline sum of longest diameters) Stable Response: Neither sufficient shrinkage to qualify for partial response, nor sufficient increase to qualify for progressive disease (taking as reference the smallest sum of diameters since the treatment started).

    Measured: 18 months

Secondary outcomes (3)

  1. Duration of Response

    Duration of response is defined as the time from when objective response is realized until time to first documented disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Objective Response = CR + PR. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.

    Measured: 18 months

  2. 6-month PFS

    Progression free survival is defined as the time from the first day of treatment until the day tumor progression was documented. Response was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST). Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions (1). Percentage of participants who were progression free at 6 month from the start of treatment is reported here.

    Measured: 6 months

  3. Overall Survival (OS)

    OS is defined as the time from the first treatment until date of death due to any cause. In the absence of confirmation of death or lack of data beyond follow-up period, the survival time was censored to last date the participant was known to be alive.

    Measured: 18 months

Timeline

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

  1. First posted24 Jan 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionFeb 2009
  4. Study completionFeb 2009

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00600015
Sponsor's protocol ID
SCRI LUN 160
Status last verified
Feb 2022
First submitted
26 Dec 2007
Last updated
10 Mar 2022
Data monitoring committee
No

Publications

  • Spigel DR, Burris HA 3rd, Greco FA, Shipley DL, Friedman EK, Waterhouse DM, Whorf RC, Mitchell RB, Daniel DB, Zangmeister J, Bass JD, Hainsworth JD. Randomized, double-blind, placebo-controlled, phase II trial of sorafenib and erlotinib or erlotinib alone in previously treated advanced non-small-cell lung cancer. J Clin Oncol. 2011 Jun 20;29(18):2582-9. doi: 10.1200/JCO.2010.30.7678. Epub 2011 May 16.

    PubMed 21576636

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Erlotinib + Sorafenib in people with Non-Small Cell Lung Cancer, run by SCRI Development Innovations, LLC at 16 sites in United States.

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 19 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 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Objective Response Rate (ORR) (time frame: 18 months). The study lists 3 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 NCT00600015, 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 10 Mar 2022.

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