Selumetinib and Paclitaxel as Second-Line Treatment in Treating Patients With Stage IIIB-IV Non-s… (NCT02503358) | Clinical Trial Compass
CompletedPhase 1
Selumetinib and Paclitaxel as Second-Line Treatment in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer
United States23 participantsStarted 2016-07-21
Plain-language summary
This randomized phase I trial is studying the side effects and the best dose of selumetinib when given together with paclitaxel as a second line therapy in treating patients with stage IIIB-IV non-small cell lung cancer (NSCLC). Selumetinib may stop or slow the growth of tumor cells by blocking a protein called mitogen-activated protein kinase (MEK) that is needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving selumetinib together with paclitaxel may kill more tumor cells.
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 and/or cytologically confirmed, non-small cell lung cancer (NSCLC) of adenocarcinoma histology at the time of initial diagnosis.
* Mixed tumors will be categorized by the predominant cell type; (Note: If small cell elements are present the patient is ineligible)
* Known mutational status of KRAS and BRAF oncogenes.
* For patients in whom mutational testing result is unknown or unavailable from a prior test, KRAS and BRAF testing will be performed (at a Clinical Laboratory Improvement Act (CLIA) -certified laboratory) using an archived or fresh biopsy as per standard of care, prior to enrollment.
* Stage IIIB-IV, locally advanced or metastatic disease according to the 7th edition of the American Joint Committee on Cancer (AJCC) lung cancer Tumor, Node, Metastasis (TNM) classification system
* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Baseline measurements and evaluation of ALL sites of disease must be obtained within 4 weeks prior to enrollment.
* Failure of at least one line of systemic anti-cancer therapy for advanced NSCLC defined as either of the following:
* Radiological documentation of disease progression (or failure to achieve a response) or
* Discontinuation due to toxicity
* Prior treatment with immunotherapy as well as maintenance therapy, including both continuation and switch maintenance will be allowed if received at least 14 days before start date of s…
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
Incidence of grade 3 or higher treatment-related adverse event (AE) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Timeframe: Up to 30 days post-treatment
2
Proportion of patients with treatment-related dose limiting toxicities (DLT) using the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Timeframe: 21 days
3
Proportion of patients with treatment-related serious adverse events (SAEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0