Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kina… (NCT02521051) | Clinical Trial Compass
TerminatedPhase 1/2
Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kinase (ALK)-Positive, Non-Small Cell Lung Cancer
Stopped: slow accrual
United States11 participantsStarted 2015-09-28
Plain-language summary
This research study is evaluating two drugs, alectinib and bevacizumab, as possible treatments for Advanced Non-Small Cell Lung Cancer (NSCLC).
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.
Inclusion Criteria:
* Histologically or cytologically confirmed advanced, non-squamous, non-small cell lung cancer.
* Molecular confirmation of an ALK rearrangement.
* Age ≥ 18 years old.
* Life expectancy \> 12 weeks.
* Performance status 0-2.
* Adequate hematologic function:
* Adequate renal function:
* An estimated Glomerular Filtration Rate (eGFR) of at least 45 mL/min/1.73 m2
* International normalized ration (INR)≤ 1.5
* Partial thromboplastin time (PTT) ≤1.5 x upper limit of normal (ULN)
* For all females of childbearing potential, a negative pregnancy test must be obtained within 3 days before starting study treatment.
* Able and willing to provide written informed consent
* Phase II Only:
* Presence of at least one measurable central nervous system (CNS) target lesion (At least 5 mm in size)
* Lesions must be untreated or progressive according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after previous local therapy.
* Participants who are receiving corticosteroids must be on a stable or decreasing dose
* At least one measurable extra-CNS lesion based upon RECIST version 1.1.
Exclusion Criteria:
* Squamous cell histology or mixed, predominantly squamous adenosquamous carcinoma
* Previous history of haemoptysis
* Tumour infiltrating into large vessels or infiltrating into the proximal tracheobronchial network
* Unstable, symptomatic brain metastases.
* History of hemorrhagic CNS metastases
* History of intracranial hemorrhage (ei…
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
(Phase 1) Recommended Phase II Dose of Alectinib
Timeframe: first cycle of treatment (21 days)
2
(Phase 1) Recommended Phase II Dose of Bevacizumab
Timeframe: first cycle of treatment (21 days)
3
(Phase 2) Number of Participants With Intracranial Hemorrhagic Events Who Received RP2D