Loading clinical trials...

Sorafenib/Erlotinib Versus Erlotinib Alone in Previously Treated Advanced Non-Small-Cell Lung Cancer (NSCLC) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT00600015•SCRI Development Innovations, LLC

View on ClinicalTrials.gov

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. Patients will be randomized to receive erlotinib (150 mg/day) and sorafenib (400 mg twice daily), or erlotinib (150 mg/day) and a placebo.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•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.
+3 more criteria

Exclusion Criteria

•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.
•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.
+9 more criteria

Locations (16)

Florida Cancer Specialists

Fort Myers, Florida, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Wellstar Cancer Research

Marietta, Georgia, United States

Kansas City Cancer Centers

Overland Park, Kansas, United States

Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, United States

Methodist Cancer Center

Omaha, Nebraska, United States

Cancer Care of Western North Carolina

Asheville, North Carolina, United States

Oncology Hematology Care

Cincinnati, Ohio, United States

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

Columbus, Ohio, United States

Key Dates

Start Date

February 1, 2008

Primary Completion Date

February 1, 2009

Completion Date

February 1, 2009

Last Updated

March 10, 2022

Enrollment

166

ACTUAL participants

Conditions

Non-Small Cell Lung Cancer

Interventions

Erlotinib + Sorafenib

DRUG

Erlotinib + Placebo

DRUG

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

View study

RECRUITINGPHASE3

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)