Bevacizumab, Pemetrexed Disodium, and Cisplatin or Erlotinib Hydrochloride and Bevacizumab in Tre… (NCT01116219) | Clinical Trial Compass
CompletedPhase 2
Bevacizumab, Pemetrexed Disodium, and Cisplatin or Erlotinib Hydrochloride and Bevacizumab in Treating Patients With Stage IV Non-Small Cell Lung Cancer. A Multicenter Phase II Trial Including Biopsy at Progression (BIO-PRO Trial).
Switzerland149 participantsStarted 2010-06
Plain-language summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether bevacizumab given together with pemetrexed disodium and cisplatin is more effective than erlotinib hydrochloride given together with bevacizumab in treating patients with non-small cell lung cancer.
PURPOSE: This phase II trial is studying giving bevacizumab together with pemetrexed disodium and cisplatin to see how well it works compared with giving erlotinib hydrochloride together with bevacizumab in treating patients with stage IV non-small cell lung cancer.
Who can participate
Age range
18 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.
DISEASE CHARACTERISTICS:
* Histologically confirmed non-small cell lung cancer of the following non-squamous subtypes:
* Adenocarcinoma
* Bronchioloalveolar carcinoma
* Large cell carcinoma
* Stage IV disease including any of the following:
* M1a (separate tumor nodule in a contralateral lobe, tumor with pleural nodules, or malignant pleural or pericardial effusion)
* M1b (distant metastasis)
* Measurable disease, defined as ≥ 1 lesion (outside of irradiated areas) that can be measured in ≥ 1 dimension as ≥ 10 mm (≥ 15 mm in case of lymph nodes) according to RECIST 1.1
* Paraffin-embedded or formalin-fixed diagnostic biopsy collected in the past 2 months must be available
* Must have EGFR-mutation status (mutated or wild type) confirmed by the central pathologist in Basel
* Must consent to tumor biopsy at progression
* No intrathoracic tumors invading or abutting major blood vessels
* No CNS metastases by mandatory CT scan (MRI within the past 3 weeks is acceptable)
PATIENT CHARACTERISTICS:
* WHO performance status 0-1
* Hemoglobin ≥ 100 g/L
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT ≤ 3 times ULN (≤ 5 times ULN if liver metastases are present)
* Alkaline phosphatase ≤ 3 times ULN (≤ 5 times ULN if liver metastases are present)
* Calculated creatinine clearance ≥ 60 mL/min
* Urine dipstick for proteinuria \< 2+
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effectiv…
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
Progression-free survival at 6 months in stratum wtEGFR cohort 1