An Efficacy and Safety Study of Cofetuzumab Pelidotin in Participants With PTK7-Expressing, Recurrent Non-Small Cell Lung Cancer

STATUS

Recruiting
days left to enroll

72
participants needed

60
sponsor

AbbVie

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Updated on 7 October 2022

See if I qualify

systemic therapy

measurable disease

lung cancer

bone marrow procedure

primary cancer

cancer chemotherapy

solid tumour

solid neoplasm

platinum-based chemotherapy

platinum doublet

recurrent non-small cell lung cancer

lung carcinoma

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.

Details

Condition	Cancer, Non-small Cell Lung Cancer (NSCLC)
Treatment	Cofetuzumab Pelidotin
Clinical Study Identifier	NCT04189614
Sponsor	AbbVie
Last Modified on	7 October 2022

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Eligibility		Yes	No	Not Sure
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 anticancer therapy (with the exception of alopecia or anemia)
	Has clinically significant medical condition(s) as described in the protocol
	Received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days prior to the first dose of study drug (no washout period required for participants on EGFR tyrosine kinase inhibitors). Palliative radiation therapy for bone, skin or subcutaneous metastases with 10 fractions or less is not subject to a washout period
	Received anti-cancer herbal therapies within 7 days prior to the first dose of study drug

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Study Definition

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An Efficacy and Safety Study of Cofetuzumab Pelidotin in Participants With PTK7-Expressing, Recurrent Non-Small Cell Lung Cancer