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

NCT ID: NCT02318368

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2017-01-31

Brief Summary

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.

Detailed Description

This is a 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.

Prior to screening, subjects will have tested positive for a sensitizing EGFR mutation to determine eligibility for treatment with erlotinib. During screening, subject serum samples will be tested using the investigational companion diagnostic (BDX004) test. Only those subjects who have a BDX004 Positive Label will be enrolled. Subject randomization will be stratified by EGFR mutation type and smoking status (ever versus never smokers). Subjects will be designated as never smokers if they have smoked less than 100 cigarettes in their lifetime. Radiographic tumor assessment, to include CT or MRI of chest and abdomen, will be performed every 4 weeks for the first 8 cycles, and every 8 weeks thereafter, using the same imaging modality per subject. Safety assessments will be performed on an ongoing basis.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ficlatuzumab plus erlotinib

150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with 20 mg/kg Ficlatuzumab administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.

Group Type: EXPERIMENTAL

Ficlatuzumab

Intervention Type: DRUG

Erlotinib

Intervention Type: DRUG

Placebo plus erlotinib

150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with Placebo administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.

Group Type: ACTIVE_COMPARATOR

Erlotinib

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Interventions

Ficlatuzumab

Intervention Type: DRUG

Erlotinib

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Other Intervention Names

Ficla; Erlotinib hydrochloride

Eligibility Criteria

Inclusion Criteria

• 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biodesix, Inc.

INDUSTRY

Sponsor Role: collaborator

AVEO Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael N Needle, MD

Role: STUDY_DIRECTOR

AVEO Pharmaceuticals, Inc.

Locations

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

AO G.Rummo

Benevento, , Italy

Policlinico S.Orsola Malpighi

Bologna, , Italy

Istituti Ospitalieri di Cremona - Oncologia

Cremona, , Italy

U.O.C. Oncologia

Lucca, , Italy

IRCCS Ospedale S.Raffaele

Milan, , Italy

Fondazione Salvatore Maugeri

Pavia, , Italy

IRCCS Istituto Clinico Humanitas

Rozzano MI, , Italy

Ospedale Treviglio-Caravaggio

Treviglio BG, , Italy

John Hopkins Singapore International Medical Center

Central Singapore, , Singapore

National Cancer Centre

Singapore, , Singapore

Korea University Guro Hospital

Guro-gu, Seoul, South Korea

Chungbuk National University Hospital

Chungcheongbuk-do, , South Korea

Chonnam National University Hwasun Hospital

Jeonnam, , South Korea

Severance Hospital, Yonsei Uni

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Chung Shan Medical University

Taichung, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

National Cheng Kung University

Tainan City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Taipei Medical University

Taipei, , Taiwan

Chang Gung Medical Foundation

Taoyuan, , Taiwan

Countries

United States; Australia; Hong Kong; Italy; Singapore; South Korea; Taiwan

Other Identifiers

AV-299-14-206

Identifier Type: -

Identifier Source: org_study_id