An Efficacy and Safety Study of Cofetuzumab Pelidotin in Participants With PTK7-Expressing, Recur… (NCT04189614) | Clinical Trial Compass
TerminatedPhase 1
An Efficacy and Safety Study of Cofetuzumab Pelidotin in Participants With PTK7-Expressing, Recurrent Non-Small Cell Lung Cancer
Stopped: Strategic considerations
United States, Israel, Japan65 participantsStarted 2020-02-13
Plain-language summary
This study is being done to determine the efficacy and safety of cofetuzumab pelidotin in the PTK7-expressing, recurrent non-small cell lung cancer (NSCLC) population.
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 confirmed non-small cell lung cancer (NSCLC) with PTK7-expressing tumor using an immunohistochemistry (IHC) assay previously validated at a designated laboratory
* Recurrent NSCLC that has progressed after treatment with at least the following approved therapies with demonstrated clinical benefit: a platinum-based chemotherapy doublet and an immune checkpoint inhibitor for tumors without targetable genetic alterations; a platinum-based chemotherapy doublet and targeted agent(s) for tumors with targeted genetic alterations
* Received ≤ 2 prior lines of systemic therapy, including no more than 1 line of systemic cytotoxic chemotherapy (≤ 3 prior lines for tumors treated with targeted agent(s) for genetic alterations, including no more than 1 line of systemic chemotherapy)
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Adequate bone marrow, renal, and hepatic function per the protocol
Exclusion Criteria:
* Known uncontrolled metastases to the central nervous system (CNS). Participants with CNS metastases may be eligible provided that definitive therapy has been given, and participants are asymptomatic and off systemic steroids and anticonvulsants used for management of brain metastases for at least 2 weeks prior to the first dose of study drug
* Unresolved clinically significant adverse events Grade ≥ 2 from prior anticanc…
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.