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Sorafenib in Treating Non-Smokers or Former Light Smokers With Relapsed or Refractory Stage IIIB or Stage IV Non-Small Cell Lung Cancer

A Phase II Study of Single Agent Sorafenib in Non-small Cell Lung Cancer Patients Who Never Smoked or Were Former Light Smokers.

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00754923
Enrollment
11
Registered
2008-09-18
Start date
2008-10-31
Completion date
2012-04-30
Last updated
2019-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer

Brief summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sorafenib works in treating non-smokers or former light smokers with relapsed or refractory stage IIIB or stage IV non-small cell lung cancer.

Detailed description

OBJECTIVES: Primary * To determine the efficacy of sorafenib tosylate, in terms of 6-month progression-free survival rate, in non-smokers or former light smokers with relapsed or refractory stage IIIB or IV non-small cell lung cancer. Secondary * To determine the 1-year survival rate in patients treated with this drug. * To assess the frequency and severity of adverse events associated with this drug in these patients. * To investigate the mutational status of EGFR (epidermal growth factor receptor), ALK (anaplastic lymphoma kinase), ROS1, and K-Ras(Kirsten rat sarcoma viral oncogene homolog)in archived tumor samples from these patients. OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Archived tumor tissue samples are analyzed for mutations of EGFR, ALK, ROS1, and K-Ras by PCR (polymerase chain reaction) and DNA (deoxyribonucleic acid) sequencing. After completion of study treatment, patients are followed every 3 months.

Interventions

DRUGsorafenib

administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient.

Sponsors

Bayer
CollaboratorINDUSTRY
Ohio State University Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer * Stage IIIB or IV disease * Recurrent disease after prior surgery, chemotherapy, or radiotherapy * No squamous cell histology or mixed tumor with \> 50% squamous cells * Non-smoker (smoked ≤ 100 cigarettes in lifetime) OR former light smoker (smoked \> 100 cigarettes but ≤ 10 pack years AND quit smoking ≥ 1 year ago) * No known brain metastasis * Patients with neurological symptoms must undergo a CT scan or MRI of the brain to exclude brain metastasis PATIENT CHARACTERISTICS: * ECOG(Eastern Cooperative Oncology Group)performance status 0-2 * ANC (Absolute Neutrophil Count)≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * ALT (Alanine Aminotransferase Test) and AST (Aspartate Aminotransferase Test) ≤ 2.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN * Bilirubin ≤ 1.5 mg/dL * Creatinine clearance ≥ 50 mL/min * INR (International Normalized Ratio) \< 1.5 OR PT/PTT (Prothrombin time/partial thromboplastin time)normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception prior to, during, and for ≥ 3 months after completion of study treatment * No cardiac disease, including any of the following: * New York Heart Association class III-IV congestive heart failure * Unstable angina (anginal symptoms at rest) * New-onset angina within the past 3 months * Myocardial infarction within the past 6 months * No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * No uncontrolled hypertension (i.e., systolic blood pressure \[BP\] \> 150 mm Hg or diastolic BP \> 90 mm Hg) despite optimal medical management * No thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months * No pulmonary hemorrhage or bleeding event ≥ CTCAE (Common Terminology Criteria for Adverse Events)grade 2 within the past 4 weeks * No other hemorrhage or bleeding event ≥ CTCAE grade 3 within the past 4 weeks * No active clinically serious infection \> CTCAE grade 2 * No serious non-healing wound, ulcer, or bone fracture * No evidence or history of bleeding diathesis or coagulopathy * No known HIV infection or chronic hepatitis B or C * No other malignancy except for any of the following: * Adequately treated basal cell or squamous cell skin cancer * In situ cervical cancer * Other cancer from which the patient has been disease-free for ≥ 5 years with a low probability of recurrence * No condition that impairs the patient's ability to swallow whole pills * No malabsorption problems * No known or suspected allergy to sorafenib tosylate or any agent given in the course of this study * No significant traumatic injury within the past 4 weeks PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No more than one prior systemic chemotherapy treatment for metastatic disease * Prior treatment with EGFR inhibitors is not considered chemotherapy * More than 4 weeks since prior major surgery or open biopsy * No prior sorafenib tosylate * No concurrent St. John's wort or rifampin * Concurrent anticoagulation with warfarin or heparin allowed

Design outcomes

Primary

MeasureTime frameDescription
Progression-free Survival at 6 Months6 monthsProgression 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, or similar definition as accurate and appropriate

Secondary

MeasureTime frameDescription
Overall Survival RateUp to 2 yearsDetermine the one year survival rate in Non/Light smokers with advanced and previouslytreated NSCLC
Incidence of Adverse Events Sssessed by Common Terminology Criteria for Adverse Events (CTCAE)Up to 2 yearsAssess the frequency and severity of adverse events associated with Sorafenib in this patient population Non/Light smokers with advanced and previously treated NSCLC.
Mutational Status for EGFR or Krasup to 2 years

Countries

United States

Participant flow

Participants by arm

ArmCount
Treatment: Sorafenib
Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle. sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient.
11
Total11

Baseline characteristics

CharacteristicTreatment: Sorafenib
Age, Continuous70 years
Sex: Female, Male
Female
8 Participants
Sex: Female, Male
Male
3 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
6 / 11
serious
Total, serious adverse events
1 / 11

Outcome results

Primary

Progression-free Survival at 6 Months

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, or similar definition as accurate and appropriate

Time frame: 6 months

ArmMeasureValue (NUMBER)
Treatment: SorafenibProgression-free Survival at 6 Months11 participants
Secondary

Incidence of Adverse Events Sssessed by Common Terminology Criteria for Adverse Events (CTCAE)

Assess the frequency and severity of adverse events associated with Sorafenib in this patient population Non/Light smokers with advanced and previously treated NSCLC.

Time frame: Up to 2 years

ArmMeasureGroupValue (NUMBER)
Treatment: SorafenibIncidence of Adverse Events Sssessed by Common Terminology Criteria for Adverse Events (CTCAE)Fatigue9 percentage of participants
Treatment: SorafenibIncidence of Adverse Events Sssessed by Common Terminology Criteria for Adverse Events (CTCAE)Rash55 percentage of participants
Secondary

Mutational Status for EGFR or Kras

Time frame: up to 2 years

ArmMeasureValue (NUMBER)
Treatment: SorafenibMutational Status for EGFR or Kras7 participants
Secondary

Overall Survival Rate

Determine the one year survival rate in Non/Light smokers with advanced and previouslytreated NSCLC

Time frame: Up to 2 years

ArmMeasureValue (MEDIAN)
Treatment: SorafenibOverall Survival Rate8.8 months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026