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Monoclonal Antibodies
Cofetuzumab Pelidotin for Recurrent Non-Small Cell Lung Cancer
Phase 1
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
Study Summary
This trial is testing a new drug to treat a certain type of lung cancer that has come back.
Who is the study for?
This trial is for adults with a specific type of lung cancer (NSCLC) that has come back after treatment. They should have tried no more than two systemic therapies, one being chemotherapy and the other an immune checkpoint inhibitor or targeted agent depending on genetic alterations in their tumor. Participants must be relatively healthy and active (ECOG 0-1), have measurable disease, good organ function, and not have serious unresolved side effects from previous cancer treatments.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of Cofetuzumab Pelidotin in patients whose NSCLC expresses PTK7 protein. It's aimed at those who've seen their cancer return despite having undergone standard treatments including platinum-based chemo and either immunotherapy or targeted therapy based on genetic changes in their tumors.See study design
What are the potential side effects?
While specific side effects for Cofetuzumab Pelidotin are not listed here, similar drugs often cause fatigue, nausea, allergic reactions, blood count changes increasing infection risk, liver or kidney issues. Side effects can vary widely between individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is confirmed and tests show PTK7 protein in my tumor.
Select...
My NSCLC has worsened despite having platinum chemotherapy and either immunotherapy or targeted therapy.
Select...
I can carry out all my daily activities without help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Duration of Response (DOR)
Overall Survival (OS)
Progression Free Survival (PFS)
Side effects data
From 2019 Phase 1 trial • 138 Patients • NCT02222922100%
Tumour pain
50%
Decreased appetite
50%
Lower gastrointestinal haemorrhage
50%
Nausea
50%
Dysarthria
100%
80%
60%
40%
20%
0%
Study treatment Arm
PF-06647020 0.5 mg/kg (Q3W Regimen)
PF-06647020 3.2 mg/kg (Q2W Regimen)
PF-06647020 2.1 mg/kg (Q3W Regimen)
PF-06647020 2.1 mg/kg (Q2W Regimen)
PF-06647020 2.8 mg/kg (Q2W Regimen)
PF-06647020 1.25 mg/kg (Q3W Regimen)
PF-06647020 0.2 mg/kg (Q3W Regimen)
PF-06647020 3.7 mg/kg (Q3W Regimen)
PF-06647020 2.8 mg/kg (Q3W Regimen)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cofetuzumab PelidotinExperimental Treatment1 Intervention
Participants will receive 2.8mg/kg of cofetuzumab pelidotin by IV every 3 weeks
Find a Location
Who is running the clinical trial?
PfizerIndustry Sponsor
4,568 Previous Clinical Trials
10,911,821 Total Patients Enrolled
AbbVieLead Sponsor
957 Previous Clinical Trials
501,881 Total Patients Enrolled
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
101,492 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have brain metastases but have been treated, symptom-free, and off certain medications for 2 weeks.I've had 2 or fewer treatments for my cancer, with only 1 being chemotherapy.I have a serious health condition mentioned in the study details.I don't have ongoing major side effects from cancer treatment, except for hair loss or anemia.I haven't had cancer treatment except for palliative radiation in the last 28 days.My lung cancer is confirmed and tests show PTK7 protein in my tumor.My NSCLC has worsened despite having platinum chemotherapy and either immunotherapy or targeted therapy.I can carry out all my daily activities without help.I have not taken any anti-cancer herbal therapies in the last 7 days.My blood, kidney, and liver tests meet the required levels.You have a tumor that can be measured using specific guidelines for evaluating tumor size.
Research Study Groups:
This trial has the following groups:- Group 1: Cofetuzumab Pelidotin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Cofetuzumab Pelidotin been sanctioned by the FDA?
"There is limited clinical data in regards to the safety and efficacy of Cofetuzumab Pelidotin, thus it has been assigned a score of 1."
Answered by AI
How widely available is this research endeavor?
"Patients are being enrolled at Stanford Univ School Medicine /ID# 213450 (Stanford, CA), Virginia Cancer Specialists /ID# 216427 (Fairfax, VA) and Sylvester Comprehensive Cancer /ID# 216433 (Miami, FL). Additionally there are 18 other sites participating."
Answered by AI
Is enrollment for the experiment still available at this time?
"Affirmative. Clinicaltrials.gov data reveals that this research initiative, which was initially uploaded to the website on February 13th 2020, is presently admitting participants. Sixty individuals must be recruited from 18 distinct healthcare centres."
Answered by AI
How many persons are being included in this investigation?
"Affirmative. Clinicaltrials.gov holds evidence that this clinical trial is still ongoing, having been initially posted on February 13th 2020 and updated most recently on November 24th 2022. A total of 60 patients are being sought after by 18 different medical sites across the country."
Answered by AI
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