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NCT00454194
NCT00454194
Who may be able to join
Who might be able to join this trial:
- You have been diagnosed with a specific type of lung cancer called non-small cell lung cancer (NSCLC) that is not the "squamous cell" type (though a mixed type called adenosquamous is allowed), confirmed by a tissue or cell sample
- Your cancer is at an advanced stage (Stage IIIB or IV)
- You have at least one tumour that is large enough to be measured on a scan (at least 2 cm using standard imaging, or at least 1 cm using a spiral CT scan)
- You have already received one round of chemotherapy treatment (a prior course of chemotherapy given after surgery counts separately and is also allowed)
- You are generally in good health and able to carry out normal daily activities with little or no limitation (confirm with trial site)
- Your doctors estimate you have a life expectancy of at least 12 weeks
- Your blood counts, kidney function, and liver function are within acceptable ranges (confirm with trial site for specific numbers)
- Your blood clotting levels are within an acceptable range (confirm with trial site)
- You are not pregnant or breastfeeding, and if you are able to have children, you agree to use effective contraception during treatment and for 2 weeks after finishing
- You are able to take folic acid, vitamin B12 supplements, and a steroid called dexamethasone as part of the treatment plan
- You are able to swallow pills
- If you have had cancer spread to the brain, it has been treated (with whole brain radiotherapy or gamma knife surgery), is stable, and you have not taken steroids for it in the past 4 weeks
- If you have fluid around the lungs causing symptoms, it has been drained before joining the trial
- You have fully recovered from any previous treatments (hair loss is an exception)
Who may not be able to join:
- Your lung cancer is the pure squamous cell type
- Your only measurable disease is in a form that cannot be properly measured on scans, such as bone lesions, fluid around the lungs or heart, cysts, or certain abdominal masses
- You have a symptomatic build-up of fluid in the body that cannot be drained (confirm with trial site)
- You have previously been treated with sorafenib or pemetrexed (the study drugs)
- You have previously been treated with certain drugs that target a specific cancer pathway called VEGF receptor (note: bevacizumab is an exception and is allowed)
- You have a known HIV infection
- You have an active, significant infection
- You have a history of bleeding disorders or problems with blood clotting
- You have had a serious bleeding episode (above a certain level of severity) in the past 4 weeks
- You have a wound, ulcer, or bone fracture that has not healed properly
- You have had a significant injury in the past 4 weeks
- You have uncontrolled high blood pressure despite medication (systolic above 150 or diastolic above 100 mm Hg)
- You have chest pain (angina), a recent heart attack (within 6 months), heart failure (within 3 months, unless heart function meets a specific threshold), or a heart rhythm problem
- You have diabetes
- You are coughing up blood
- You have another active cancer, unless it is a very early-stage skin cancer or cervical cancer in situ, or a cancer that was fully treated more than 5 years ago with no return; certain early prostate or breast conditions that have been treated may still be allowed (confirm with trial site)
- You have another serious illness that the doctor feels would make participation unsafe
- You are currently taking steroids
- You are currently taking blood-thinning medication for treatment purposes (low-dose preventive anticoagulation for a line or port may be allowed — confirm with trial site)
- You are taking high doses of aspirin (1.3 grams or more per day) in the period around the study treatment
- You are currently taking antiretroviral therapy (HIV medications)
- You are taking St. John's Wort (a herbal supplement)
- You are consuming grapefruit or grapefruit juice
- You are receiving any other cancer treatments at the same time
- You have not waited long enough since your last treatment (waiting periods vary by treatment type — confirm with trial site)
- More than 25% of your bone marrow has
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Trial details
Status
Completed
Phase
Phase 2
Sponsor
Alliance for Clinical Trials in Oncology
Registry
clinicaltrials_gov
Start date
1 September 2007
Est. completion
1 July 2010
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Progression-free Survival
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.