A Phase 2, Study of Ficlatuzumab Plus Erlotinib vs. Placebo Plus Erlotinib in Subjects With Previously Untreated Metastatic, EGFR-mutated NSCLC and BDX004 Positive Label

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Non-small Cell Lung Cancer

In brief

Phase 2 multicenter, controlled, randomized, double-blind study to evaluate the efficacy and safety of ficlatuzumab versus placebo when administered with erlotinib in subjects with previously untreated metastatic EGFR-mutated NSCLC and BDX004 Positive Label.

Key facts

Study ID

NCT02318368

Run by

AVEO Pharmaceuticals, Inc.

People needed

10

Starts

2014-11-01

Expected to finish

2017-01-01

Last updated by the study team

2020-10-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically and/or cytologically confirmed primary diagnosis of Stage IV NSCLC (according to American Joint Committee on Cancer [AJCC] 7th edition lung cancer staging criteria).
• Measurable disease according to RECIST v.1.1.
• An EGFR exon 19 deletion and/or an exon 21 (L858R) substitution mutation.
• BDX004 Positive Label.
• Have received no prior systemic chemotherapy, immunotherapy, targeted therapy, or biologic therapy for metastatic NSCLC. Subjects may have previously been treated with postoperative adjuvant chemotherapy for early stage lung cancer or chemo radiotherapy for locally advanced disease provided this was completed at least 6 months prior to enrollment. No prior EGFR TKI therapy is allowed for any stage of NSCLC.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria
• History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent or erlotinib.
• History of known brain metastases.
• Prior treatment with any other investigational drug or biologic agent within 5 half lives prior to randomization, or any investigational device within 2 weeks prior to randomization.
• Any unresolved toxicity from previous radiation therapy.
• Significant cardiovascular disease, including:
• Echocardiogram (ECHO) or multiple gated acquisition (MUGA) showing left ventricular ejection fraction of less than 55%.
• Cardiac failure New York Heart Association class III or IV.
• Myocardial infarction, severe or unstable angina within 6 months prior to randomization.
• History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation).
• Significant thrombotic or embolic events within 3 months prior to randomization (significant thrombotic or embolic events include but are not limited to stroke or transient ischemic attack).
• Any uncontrolled or severe cardiovascular disease.
• History of prior malignancy within 3 years prior to randomization (except for adequately treated non-melanoma skin cancer, carcinoma in situ of the breast or cervix, superficial bladder cancer, or early stage prostate cancer, without evidence of recurrence).
• Radiographic evidence of interstitial lung disease.

Where it is running

• UCSF Fresno — Fresno, California, United States
• Torrance Memorial Medical Center — Redondo Beach, California, United States
• Boca Raton Regional Hospital Lynn Cancer Institute — Boca Raton, Florida, United States
• University of Miami Sylvester Comprehensive Cancer Center Deerfield Beach — Deerfield Beach, Florida, United States
• Kaiser Permanente Hawaii — Honolulu, Hawaii, United States
• Cancer Center of Acadiana — Lafayette, Louisiana, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Valley Medical Group — Paramus, New Jersey, United States
• Queens Hospital Cancer Center — Jamaica, New York, United States
• Aultman Hospital — Canton, Ohio, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• UPMC Cancer Center Cancer — Pittsburgh, Pennsylvania, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia
• North Coast Cancer Institute — Coffs Harbour, New South Wales, Australia
• Concord Repatriation General Hospital — Concord, New South Wales, Australia
• Townsville Hospital — Douglas, Queensland, Australia
• Icon Cancer Care — Southport, Queensland, Australia
• Princess Alexandra Hospital — Wolloongabba, Queensland, Australia
• Flinders Medical Centre — Bedford Park, South Australia, Australia
• Eastern Health — Box Hill, Victoria, Australia
• Frankston Hospital — Frankston, Victoria, Australia
• Ballarat Oncology and Haematology — Wendouree, Victoria, Australia
• Tuen Mun Hospital — Tuenmen, N.T, Hong Kong
• Queen Mary Hospital — Pok Fu Lam, Hong Kong

Full record on ClinicalTrials.gov

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