A Study of Carboplatin and Paclitaxel With or Without MEDI-575 in Untreated, Advanced Non-Small Cell Lung Cancer

Stopped early · Phase 1/Phase 2

Conditions studied: Non-small Cell Lung Cancer

In brief

The purpose of this study is to evaluate the dose, antitumor activity, safety and pharmacology of MEDI-575 in combination with carboplatin/paclitaxel in subjects with previously untreated, advanced non-small cell lung cancer (NSCLC).

Key facts

Study ID: NCT01268059
Run by: MedImmune LLC
People needed: 99
Starts: 2010-12-16
Expected to finish: 2013-09-11
Last updated by the study team: 2020-12-23

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically confirmed inoperable Stage IIIB or Stage IV non-small cell lung cancer according to the Seventh Edition of the American Joint Committee on Cancer (AJCC) Tumor Node Metastases (TNM) staging system (only participants with squamous cell carcinoma will be enrolled)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy of greater than or equal to (>=) 3 months
Prothrombin time elevation less than or equal to (<=) Grade 2 by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) criteria (Version 4.0) is acceptable for participants on anticoagulant therapy
Adequate hematologic function
Adequate organ function
Suitable candidates for therapy with carboplatin/paclitaxel
Participants must have at least 1 lesion that is measurable using Response Evaluation Criteria for Solid Tumors
Participants must be willing to consent to allow collection of archived NSCLC tumor samples
Negative serum beta-human chorionic gonadotropin (beta-hCG) test (women of childbearing potential only)
Females of childbearing potential, unless surgically sterile has a sterile male partner, is premenarchal or at least 2 years postmenopausal, or practices abstinence, must use 2 effective methods of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, or use of a condom with spermicide by the sexual partner) from screening, and must agree to continue using such precautions for 90 days after the final dose of treatment; cessation of birth control after this point should be discussed with a responsible physician
Males, unless surgically sterile, must use 2 effective methods of birth control with a female partner and must agree to continue using such contraceptive precautions from screening through 90 days after the final dose of treatment

You may not qualify if…

At discretion of the investigator regarding safety of the participants
Concurrent enrollment in another clinical study
Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic, or hormonal therapy for treatment of cancer
Previous monoclonal antibody (mAb) treatment specifically directed against platelet-derived growth factor (PDGF) or PDGF receptors
History of serious allergy or reaction to any component of the MEDI-575 formulation
Receipt of any previous systemic anticancer therapies for advanced or metastatic disease
Previous adjuvant/neoadjuvant radiotherapy or chemotherapy for treatment of previous nonmetastatic disease is allowed provided that 6 months have elapsed from the end of such therapies to the time of enrollment
New York Heart Association >= Class II congestive heart failure
History of myocardial infarction, unstable angina, transient ischemic attack or stroke within the previous 6 months prior to enrollment
History of other invasive malignancy within 5 years except for cervical carcinoma in situ (CIS), non-melanomatous carcinoma of the skin or ductal carcinoma in situ (DCIS) of the breast that have been surgically cured
Evidence of active infection requiring the use of systemic antimicrobial treatment within 72 hours prior to initial treatment with MEDI-575
Use of immunosuppressive medication (inhaled and topical corticosteroids are permitted) within 7 days prior to enrollment
Systemic immunosuppressive steroid therapy
Participants may take replacement doses of steroids if on a stable dose for at least 2 weeks prior to enrollment
History of active human immunodeficiency virus (HIV) or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Pregnancy or lactation
Previous medical history or evidence of an inter-current illness
Any physical, social, or psychiatric condition which would prevent effective cooperation or participation in the study

Where it is running

Research Site — Fountain Valley, California, United States
Research Site — Oxnard, California, United States
Research Site — Chicago, Illinois, United States
Research Site — Lafayette, Indiana, United States
Research Site — Baton Rouge, Louisiana, United States
Research Site — Annapolis, Maryland, United States
Research Site — Baltimore, Maryland, United States
Research Site — Baltimore, Maryland, United States
Research Site — Boston, Massachusetts, United States
Research Site — Danvers, Massachusetts, United States
Research Site — Detroit, Michigan, United States
Research Site — Omaha, Nebraska, United States
Research Site — Lake Success, New York, United States
Research Site — Canton, Ohio, United States
Research Site — Hershey, Pennsylvania, United States
Research Site — Hilton Head Island, South Carolina, United States
Research Site — Chattanooga, Tennessee, United States
Research Site — Corpus Christi, Texas, United States
Research Site — Houston, Texas, United States
Research Site — Ottawa, Ontario, Canada
Research Site — Marseille, France
Research Site — Berlin, Germany
Research Site — Szombathely, Hungary
Research Site — Fukuoka, Japan
Research Site — Sunto-gun, Japan

Full record on ClinicalTrials.gov

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