Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung)
Conditions
Lung Cancer - Non Small Cell Lung Cancer.
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Bronchogenic, Bronchial Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases, Erlotinib, Therapeutic Uses, Pharmacologic Actions, Molecular Mechanisms of Pharmacological Action
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention
Name: Patritumab Type: Drug
Name: erlotinib: Type: Drug
Name: Placebo Type: Drug
Overall Status
Recruiting
Summary
1. Part A: Subjects will receive Patritumab or placebo with erlotinib. Progression-free survival will be the primary outcome. Subjects will need to have Epidermal Growth Factor Receptor (EGFR) wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2 (Human Epidermal Growth Factor Receptor 2), anti-HER3, or anti-HER4 therapy. Subjects may have high heregulin or low heregulin.

2. Part B: Subjects will receive Patritumab or placebo with erlotinib. Overall survival will be the primary outcome. Subjects will need to have EGFR wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy. Only subjects with high heregulin will be enrolled.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Must be greater or equal to 20 years of age

2. Must have histologically confirmed NSCLC with either:

- Metastatic disease (Stage IV) OR

- Stage IIIB disease not amenable to surgery or curative intent.

3. If tumor histology is adenocarcinoma, must have wild-type EGFR genotype as assessed by a validated assay that includes exon 19 deletion and exon 21 (L858R) substitution.

4. Must have received one or two prior lines of systemic anti-cancer therapy for advanced or metastatic disease, one of which must be a platinum-doublet therapy.

5. Must have disease progression or recurrence documented by radiographic assessment following treatment after last chemotherapy or chemoradiation regimen (completed within the previous 12 months).

6. Must have available recent (before treatment start) or archival tumor specimen.

7. Must have measurable disease for Part A, measurable disease or non-measurable disease for Part B

8. Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

9. Must have adequate hematological function

10. Must have adequate renal function

11. Must have adequate hepatic function

12. Agreement to use effective contraception while on treatment and for at least 6 months after end of treatment

13. Must have provided informed consent for study participation.

Exclusion Criteria:

1. Lung adenocarcinoma with an Anaplastic Lymphoma Kinase (ALK) gene rearrangement

2. Left ventricular ejection fraction (LVEF) less than 45%

3. Prior EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy

4. History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for greater or equal to 5 years

5. History of corneal disease

6. History of interstitial lung disease (ILD)

7. Clinically active brain metastases

8. Uncontrolled hypertension

9. Clinically significant ECG changes

10. Clinically significant (any grade) ascites or pleural effusion requiring chronic medical intervention

11. Myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure, unstable angina, or unstable cardiac arrhythmia requiring medication

12. Treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within 4 weeks before study drug treatment

13. Therapeutic radiation therapy or major surgery within 4 weeks before study drug treatment; or palliative radiation within 2 weeks before study drug treatment

14. Participation in clinical drug trials within 4 weeks

15. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.

16. History of hypersensitivity to any of the study drugs or to any excipients.
Locations
Glendale, Arizona, United States
Status: Recruiting
Redmond, Arizona, United States
Status: Recruiting
Contact: William G Schmidt Jr. - 541-382-2811
Duarte, California, United States
Status: Recruiting
Contact: Koczywas - 626-256-4673
La Verne, California, United States
Status: Recruiting
Las Angeles, California, United States
Status: Recruiting
Contact: Gregory Otterson - 614-293-9424
Orange, California, United States
Status: Recruiting
Contact: Sai-Hong Ignatius Ou - 714-456-8104
Orange, California, United States
Status: Recruiting
Contact: Sai-Hong Ignatius Ou - 714-456-8104
San Francisco, California, United States
Status: Recruiting
Contact: Ari D. Baron - 415-923-3012
Port St. Lucie, Florida, United States
Status: Recruiting
Contact: Iannotti - (772) 353-4899
Tampa, Florida, United States
Status: Recruiting
Chicago, Illinois, United States
Status: Recruiting
Contact: Ravi Ravi Salgia - 773-702-4399
Maywood, Illinois, United States
Status: Recruiting
Goshen, Indiana, United States
Status: Recruiting
Contact: Ebenezer Kio - 574-364-2888
Goshen, Indiana, United States
Status: Recruiting
Contact: Ebenezer A Kio - 574-364-2888
Louisville, Kentucky, United States
Status: Recruiting
Cloud, Minnesota, United States
Status: Recruiting
Contact: Donald Jurgens - 320-229-5160
St. Louis, Missouri, United States
Status: Recruiting
Las Vegas, Nevada, United States
Status: Recruiting
Contact: Braiteh, MD - 702-952-3400 - fadi.braiteh@usoncology.com
Columbus, Ohio, United States
Status: Recruiting
Contact: Greg Otterson - 614-293-9424
Bend, Oregon, United States
Status: Recruiting
Contact: William G. Schmidt Jr - 541-382-2811
Portland, Oregon, United States
Status: Recruiting
Chattanooga, Tennessee, United States
Status: Recruiting
Contact: Gandhi, MD - 423-622-2337
Knoxville, Tennessee, United States
Status: Recruiting
Contact: DeVore, MD - 865-934-2670
Nashville, Tennessee, United States
Status: Recruiting
Contact: David R. Spigel - 615-329-7272
Salt Lake City, Utah, United States
Status: Recruiting
Contact: Akerley - (801) 585-0303
Fairfax, Virginia, United States
Status: Recruiting
Contact: Spira, MD - 703-280-5390 - alexander.spira@usoncology.com
Seattle, Washington, United States
Status: Recruiting
Contact: West - 206-386-2424 - howard.west@swedish.org
Brasschaat, Antwerpen, Belgium
Status: Recruiting
Bruxelles, Brussels, Belgium
Status: Recruiting
Charleroi, Hainaut, Belgium
Status: Recruiting
Contact: Jean-Luc Canon, MD - 800-422-6237
Charleroi, Belgium
Status: Recruiting
Contact: Jean-Luc Canon - 071.104.701
Gent, Belgium
Status: Recruiting
Contact: Paul Germonpre - 32-(0)3-843-2519
Gent, Belgium
Status: Recruiting
Contact: Paul Germonpre - 32(0)3-843-2519
Liege, Belgium
Status: Recruiting
Yvoir, Belgium
Status: Recruiting
Contact: Sebahat Ocak - 32.81.423.374
Yvoi, Belgium
Status: Recruiting
Contact: Sebahat Ocak - 32-81-423-374
Hamilton, Ontario, Canada
Status: Recruiting
Kingston, Ontario, Canada
Status: Recruiting
Levis, Quebec, Canada
Status: Recruiting
Contact: Felix Couture - 418-835-7121
Montreal, Quebec, Canada
Status: Recruiting
Toronto, Canada
Status: Recruiting
Contact: Natasha Leighl - 416-946-4646
Ostava-Poruba, Czech Republic
Status: Recruiting
Contact: Jaromir Roubec - 597 372 240
Ostrava-Poruba, Czech Republic
Status: Recruiting
Contact: Jaromir Roubec Roubec - 420 597 371 111
Koln, Nordrhein-Westfalen, Germany
Status: Recruiting
Rheine, Nordrhein-Westfalen, Germany
Status: Recruiting
Esslingen am Neckar, Germany
Status: Recruiting
Contact: Martin Faehling - 49-0711-3103-2402
Frankfurt am Main, Germany
Status: Recruiting
Contact: Akin Atmaca - 069-7601-3297
Gauting, Germany
Status: Recruiting
Contact: Joachim von Pawel - 49(89)-85-791-4109
Gauting, Germany
Status: Recruiting
Contact: Joachim von Pawel - 49 89 857910
Gerlingen, Germany
Status: Recruiting
Contact: Martin Kimmich - 00497156-2030
Gieben, Germany
Status: Recruiting
Grosshansdorf, Germany
Status: Recruiting
Contact: Niels Reinmuth - 49-4102-601-2141
Halle, Germany
Status: Recruiting
Contact: Wolfgang Schutte - 49-345-559-1429
Heidelberg, Germany
Status: Recruiting
Contact: Heidrun Grosch - 49-6221-396-1301
Immenhausen, Germany
Status: Recruiting
Contact: Achim Rittmeyer
Mainz, Germany
Status: Recruiting
Contact: Cornelius Kortsik - 06-131-147-606
Munchen, Germany
Status: Recruiting
Contact: Martin Schutz - 49-899-270-4316
Ulm, Germany
Status: Recruiting
Contact: Cornelia Kropf-Sanchen - 0049 (0) 731-5004-5061
Villingen-Schwenningen, Germany
Status: Recruiting
Contact: Wolfram Brugger
Szolnok, Jasz-Nagykun-Szolnok, Hungary
Status: Recruiting
Gyor, Hungary
Status: Recruiting
Contact: Zsuzsanna Szalai - 36-30-949-20-72
Gyor, Hungary
Status: Recruiting
Contact: Zsuzsanna Szalai - 06-30-975-8356
Szekesfehervar, Hungary
Status: Recruiting
Contact: Zsolt Papai-Szekely - 1437862893
Szekesfehervar, Hungary
Status: Recruiting
Contact: Zsolt Papai-Szekely - zsoltpapai@yahoo.com
Tatabanya, Hungary
Status: Recruiting
Meldola, Forli, Italy
Status: Recruiting
Lecco, Lombardia, Italy
Status: Recruiting
Benevento, Italy
Status: Recruiting
Contact: Daniele Bruno - 39-082-457-724
Bologna, Italy
Status: Recruiting
Contact: Barbara Melotti - 39-051-636-2203
Cremona, Italy
Status: Recruiting
Faenza, Italy
Status: Recruiting
Genova, Italy
Status: Recruiting
Contact: Francesco Grossi - 39-010-560-0385
Milano, Italy
Status: Recruiting
Contact: Filippo De Marinis
Napoli, Italy
Status: Recruiting
Contact: Alessandro Morabito - 39-081-590-3571
Napoli, Italy
Status: Recruiting
Contact: Alessandro Morabito - 091-590-3638-563
Perugia, Italy
Status: Recruiting
Ravenna, Italy
Status: Recruiting
Rimini, Italy
Status: Recruiting
Roma, Italy
Status: Recruiting
Rozzano, Italy
Status: Recruiting
Contact: Armando Santoro - 39 02 82244540
Rozzano, Italy
Status: Recruiting
Contact: Armando Santoro - 39-02-8224-4080
Sora, Italy
Status: Recruiting
Contact: Teresa Gamucci
Gdansk, Pomorskie, Poland
Status: Recruiting
Krakow, Poland
Status: Recruiting
Otwock, Poland
Status: Recruiting
Contact: Aleksandra Szczesna - 48-22-344-6302
Prabuty, Poland
Status: Recruiting
Szezecin, Poland
Status: Recruiting
Contact: Piotr Serwatowski - 48-91-442-7209
Szezecin, Poland
Status: Recruiting
Contact: Piotr Serwatowski - 91 464 50 36
Torun, Poland
Status: Recruiting
Contact: Piotr Sawrycki
Warszawa, Poland
Status: Recruiting
Sevilla, Andalucia, Spain
Status: Recruiting
A Coruna, Spain
Status: Recruiting
Contact: Margarita Amenedo - 981287499
Alicante, Spain
Status: Recruiting
Contact: Bartomeu Massuti - 34-965-933-513
Barcelona, Spain
Status: Recruiting
Contact: Santiago Viteri
Barcelona, Spain
Status: Recruiting
Contact: Enriqueta Felip - 93 238 16 61
Barcelona, Spain
Status: Recruiting
Contact: Ramon Palmero - 93 260 77 44
Barcelona, Spain
Status: Recruiting
Contact: Alvaro Taus - 34-93-248-3612
Barcelona, Spain
Status: Recruiting
Contact: Enriqueta Felip - 34-93-274-6085
Barcelona, Spain
Status: Recruiting
Contact: Ramon Palmero - 34-93-260-7744
Barcelona, Spain
Status: Recruiting
Contact: Margarita Majem - 34-93-556-5638
Barcelona, Spain
Status: Recruiting
Contact: Alvaro Taus Garcia - 93 248 31 37
Burgos, Spain
Status: Recruiting
Contact: Carlos Garsia - 947257730
Burgos, Spain
Status: Recruiting
Contact: Carlos Garcia - 34-93-274-6085
Coruna, Spain
Status: Recruiting
Contact: Margarita Margarita Amenedo - 34-98-128-7499
Madrid, Spain
Status: Recruiting
Contact: Santiago Ponce - 34-91-469-2313
Madrid, Spain
Status: Recruiting
Contact: Manuel Domine - 34-91-550-4916
Madrid, Spain
Status: Recruiting
Contact: Jose M. Sanchez
Madrid, Spain
Status: Recruiting
Contact: Manuel Domine - 915504800
Manresa, Spain
Status: Recruiting
Contact: Silvia Catot - 938.776.595
Manresa, Spain
Status: Recruiting
Contact: Silvia Catot - 34-93-874-2112
Palma de Mallorca, Spain
Status: Recruiting
Contact: Juan Coves - 34-871-202-000
Valencia, Spain
Status: Recruiting
Contact: Miguel Munoz - 34-96-111-4229
Valencia, Spain
Status: Recruiting
Contact: Javier Garde - 34-96-398-7700
Zaragoza, Spain
Status: Recruiting
Contact: Dolorez Isla - 34-97-676-5746
London, United Kingdom
Status: Recruiting
Contact: Hendrik-Tobias Arkenau - 44-0-203-219-5251
London, United Kingdom
Status: Recruiting
Contact: Martin Forster - 0203 447 5085
London, United Kingdom
Status: Recruiting
Contact: Hendrik-Tobias Arkenau - 44(0) 203 219 5251
London, United Kingdom
Status: Recruiting
Contact: Rohit Lal - 0207 188 4255
London, United Kingdom
Status: Recruiting
Contact: Martin Forster - 44-020-3447-5085
London, United Kingdom
Status: Recruiting
Contact: Rohit Lal - 44-207-188-7188
Northwood, United Kingdom
Status: Recruiting
Contact: Andreas Polychronis - 0193-384-4526-
Rickmansworth, United Kingdom
Status: Recruiting
Southampton, United Kingdom
Status: Recruiting
Contact: Christian Ottensmeier - 44-23-8120-5048
Southhampton, United Kingdom
Status: Recruiting
Contact: Christian Ottensmeier - 023 8120 6184
Wirral, United Kingdom
Status: Recruiting
Contact: Richard W Griffiths - 0151 334 1155
Wirral, United Kingdom
Status: Recruiting
Contact: Richard W Griffiths - 44-151-334-1155
Start Date
March 2014
Completion Date
September 2018
Sponsors
Daiichi Sankyo Inc.
Source
Daiichi Sankyo Inc.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page