Pemetrexed/Platinum With or Without Bevacizumab in Brain Metastases From Patients With EGFR/ALK N… (NCT01951482) | Clinical Trial Compass
CompletedPhase 3
Pemetrexed/Platinum With or Without Bevacizumab in Brain Metastases From Patients With EGFR/ALK Negative Non-Squamous Non-small Cell Lung Cancer
China160 participantsStarted 2016-01
Plain-language summary
This is a multi-center phase 3 randomized controlled study to assess the efficacy of Pemetrexed/platinum with or without Bevacizumab on patients with brain metastasis from non-small cell lung cancer(NSCLC) harboring EGFR/ALK wild type by intracranial PFS(iPFS), also PFS ,ORR, DCR and OS. The safety is evaluated as well.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically or cytologically confirmed non-squamous non-small cell lung cancer (Patients with NSCLC who are newly diagnosed or treated with brain metastases who are asymptomatic or whose intracranial hypertension symptoms are relieved after dehydration treatment, and whose baseline examinations show EGFR wild type (tissue specimen or blood specimen) and ALK negative (tissue specimen);
. Patients with MRI-confirmed brain metastasis and ≥3 brain lesions; or patients with 1-2 brain lesions but not suitable for local treatment or refusing local treatment. At least one of the brain lesions must be \>5 mm in diameter.
. Age 18-75 years old;
. Physical condition ECOG score (PS) 0-1;
. The patient's major organ functions are normal, that is, they meet the following criteria: white blood cells count ≥ 4.0x109/L, neutrophil cells count ≥1.5x109/L, hemoglobin ≥100g/L, serum bilirubin ≤1.5 times the upper limit of normal, transaminase ≤2.5 times the upper limit of normal, if there is liver metastasis, less than 5 times the upper limit of normal; serum creatinine is less than 1.5 times the upper limit of normal, or creatinine clearance is greater than 50ml/min and urine protein is \<2+. Patients with baseline urine protein ≥2+ should collect 24-hour urine and prove that the 24-hour urine protein quantitative test is ≤1g.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Compare iPFS(intracranial progression free survival) in two arms
. Expected survival time is greater than 12 weeks;
. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the result must be negative, and they must be willing to use appropriate contraceptive methods during the trial and within 8 weeks after the last administration of the trial drug. For men, they must agree to use appropriate contraceptive methods during the trial and within 8 weeks after the last administration of the trial drug or have undergone surgical sterilization;
. Ability to comply with study and follow-up procedures;
Exclusion criteria
. Mixed non-small cell and small cell carcinoma, or mixed adenosquamous carcinoma with squamous cells as the main component;
. Before selection3 A history of hemoptysis within the past month, that is, coughing up at least half a teaspoon of blood;
. Brain metastases with bleeding;
. Imaging shows evidence of tumor invasion of large blood vessels. The investigator or radiologist must rule out that the tumor has completely patients with full access, encasement, or invasion into the lumen of large vessels (e.g., pulmonary artery or superior vena cava);
. Before selection 28 Underwent major surgery (including thoracotomy) within 1 day, suffered major trauma, or patients who are expected to require major surgery during study treatment;
. First-time bevacizumab/Before placebo treatment48 Minor surgical procedures (including port placement) within 24 hours PICC except);
. Currently or recently (before receiving first dose of bevacizumab10 Aspirin use (\>325 mg/Days) or other nonsteroidal anti-inflammatory drugs known to inhibit platelet function;
. Currently or recently (before receiving first dose of bevacizumab10 within 2 days) take full dose orally or parenterally anticoagulants or thrombolytics are used for treatment. Prophylactic use of anticoagulants is allowed in patients with deep venous catheters;