Phase 2 Study of Maintenance OSI-906 Plus Erlotinib (Tarceva®), or Placebo Plus Erlotinib in Patients With Nonprogression Following 4 Cycles of Platinum-based Chemotherapy

NCT01186861 | Completed Phase 2 DMC

• 2 other identifiers: OSI-906-2052010-020916-12
• Study Type: interventional
• Target: 205
• Locations: 9 countries
• Sites: 69

Brief Summary

A multicenter, randomized, double-blind, placebo-controlled, phase 2 study with a 1:1 randomization scheme.

Conditions

Non-Small Cell Lung Cancer (NSCLC) With Nonprogression Following 4 Cycles of Platinum-based Chemotherapy

Keywords

OSI-906; Erlotinib; Platinum-based chemotherapy; Placebo; NSCLC

Outcome Measures

Primary Outcomes (1)

• The Progression Free Survival (PFS) of maintenance OSI-906 plus erlotinib, or placebo plus erlotinib in patients with nonprogression following four cycles of first-line platinum-based chemotherapy for advanced NSCLC in the overall population

  PFS is defined as the time from randomization to disease progression based on RECIST v1.1 or death due to any cause whichever comes first

  22 months

Secondary Outcomes (6)

• Overall survival (OS)

  27 months

• Disease control Rate (DCR)

  27 months

• Best overall response rate (ORR)

  27 months

• Response upgrade rate (RUR)

  27 months

• Duration of response

  27 months

Study Arms (2)

Arm A: OSI-906 plus erlotinib

EXPERIMENTAL

OSI-906 150 mg twice daily (BID) starting on Day 1; erlotinib 150 mg once daily (QD) starting on Day 1

Drug: OSI-906; Drug: erlotinib

Arm B: placebo plus erlotinib

PLACEBO COMPARATOR

placebo BID starting on Day 1: erlotinib 150 mg QD starting on Day 1

Drug: erlotinib; Drug: placebo

Interventions

OSI-906 DRUG

Tablet administered with food and with up to 200 mL of water

Arm A: OSI-906 plus erlotinib

erlotinib DRUG

Tablet administered at least 2 hours after food with up to 200 mL of water

Also known as: OSI-774, Tarceva

Arm A: OSI-906 plus erlotinib; Arm B: placebo plus erlotinib

placebo DRUG

Tablet administered at least 2 hours after food with up to 200 mL of water

Arm B: placebo plus erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed locally advanced or metastatic stage IIIB or IV NSCLC
• Have experienced Complete Response (CR), Partial Response (PR) or Stable Disease (SD) following completion of 4 cycles of first-line platinum-based chemotherapy and are not progressing at time of entry into study (prior completed first-line combination bevacizumab therapy is permitted; however, current use of maintenance bevacizumab is not permitted. A maximum interval of 28 days between the last day of the treatment cycle and randomization
• Patient has recovered from prior chemotherapy-related toxicity to ≤ grade 2
• EGFR mutation status must be confirmed for participation in the study. EGFR analysis can be performed either by central or local laboratory. If analysis is done locally, verifiable documentation confirming the EGFR mutation status must be submitted for review and approval by APGD prior to randomization. If no local result is available, formalin-fixed, paraffin-embedded archival tissue representative of the tumor or in the absence of archival tissue, a fresh tumor tissue sample of sufficient size to perform EGFR mutation analysis must be submitted centrally. Results of the central analysis must be available prior to randomization. Additionally, subjects should provide tissue blocks centrally for biomarker analysis whenever possible. Ideal tissue requirement: block with ≥5 mm2 tumor area sufficient to provide four 4-micron, and five 10-micron sections)
• Measurable disease (for those patients with PR or SD after first-line platinum-based chemotherapy) according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)
• Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) 0 - 1
• Previous adjuvant or neo-adjuvant treatment is permitted
• Must be able to take oral medication
• Fasting glucose ≤ 150 mg/dL (8.3 mmol/L). Concurrent use of non-insulinotropic antihyperglycemic therapy is permitted if the dose has been stable for ≥ 4 weeks at the time of randomization
• Adequate hematopoietic, hepatic, and renal function defined as follows:
• Neutrophil count ≥ 1.5 x 109/L
• Platelet count ≥ 100 x 109/L
• Bilirubin ≤ 1.5 x Upper Limit of Normal (ULN)
• AST and ALT ≤ 2.5 x ULN, or ≤ 5 x ULN if patient has documented liver metastases
• Serum creatinine ≤ 1.5 x ULN

You may not qualify if:

• Prior exposure to agents directed at the Human Epidermal Receptor (HER) axis (eg, erlotinib, gefitinib, cetuximab, and trastuzumab)
• Malignancies other than NSCLC within past 3 years (exceptions if curatively treated: basal or squamous cell carcinoma of skin; locally advanced prostate cancer; ductal carcinoma in situ of breast; in situ cervical carcinoma; and superficial bladder cancer)
• Type 1 diabetes mellitus or Type 2 diabetes mellitus currently requiring insulinotropic or insulin therapy
• Prior insulin-like growth factor receptor (IGF-1R)
• Prior investigational agent within 21 days prior to randomization
• Concurrent use of maintenance bevacizumab
• History of poorly controlled gastrointestinal disorders that could affect the absorption of study drug (eg, Crohn's disease, ulcerative colitis, etc)
• History (within last 180 days) of significant cardiovascular disease unless the disease is well-controlled. Significant cardiac disease includes second/third degree heart block; clinically significant ischemic heart disease; superior vena cava (SVC) syndrome; poorly controlled hypertension; congestive heart failure of New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea)
• History of arrhythmia (multifocal premature ventricular contractions \[PVCs\], bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) that is symptomatic or requires treatment (≥ grade 3), left bundle branch block (LBBB), or asymptomatic sustained ventricular tachycardia are not allowed. Patients with atrial fibrillation controlled by medication are not excluded
• Mean QTcF interval \> 450 msec based on independent central reviewer analysis of screening visit ECGs
• Use of drugs that have a known risk of causing Torsades de Pointes (TdP) are prohibited within 14 days prior to randomization
• Use of the potent CYP1A2 inhibitors ciprofloxacin and fluvoxamine. Other less potent CYP1A2 inhibitors/inducers are not excluded
• Use of potent CYP3A4 inhibitor such as ketoconazole, clarithromycin, atazanavir, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), or voriconazole
• Use of proton pump inhibitors such as omeprazole. Use of H2-receptor antagonists such as ranitidine are not excluded
• History of cerebrovascular accident (CVA) within 180 days prior to randomization or that resulted in ongoing neurologic instability

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (69)

Site US10007

Jacksonville, Florida, 32207, United States

Location

Site US10001

Port Saint Lucie, Florida, 34952, United States

Location

Site US10002

Albany, Georgia, 31701, United States

Location

Site US10008

Chicago, Illinois, 60612, United States

Location

Site US10011

Scarborough, Maine, 04074, United States

Location

Site US10004

Greensboro, North Carolina, 27403, United States

Location

Site US10010

Winston-Salem, North Carolina, 27103, United States

Location

Site BR55005

Barretos, 14784-400, Brazil

Location

Site BR55004

Brasília, 70840-050, Brazil

Location

Site BR55015

Cachoeiro de Itapemirim, 29308-014, Brazil

Location

Site BR55011

Florianópolis, 88034-000, Brazil

Location

Site BR55003

Fortaleza, 60336-550, Brazil

Location

Site BR55016

Goiânia, 74605-030, Brazil

Location

Site BR55006

Ijuí, 98700-000, Brazil

Location

Site BR55001

Itajaí, 88301-220, Brazil

Location

Site BR55008

Piracicaba, 13419-155, Brazil

Location

Site BR55013

Porto Alegre, 90430-090, Brazil

Location

Site BR55014

Porto Alegre, 90610-000, Brazil

Location

Site BR55012

Ribeirão Preto, 14515-130, Brazil

Location

Site BR55002

Rio de Janeiro, 20231-050, Brazil

Location

Site BR55007

São Paulo, 01323-920, Brazil

Location

Site CA11001

Oshawa, L1G 2B9, Canada

Location

Site CA11004

Ottawa, K1H 8L6, Canada

Location

Site CA11006

Toronto, M5G 1X5, Canada

Location

Site CA11002

Toronto, M6R 1B5, Canada

Location

Site DE49014

Berlin, 10117, Germany

Location

Site DE49008

Cologne, 51109, Germany

Location

Site DE49011

Dortmund, 44145, Germany

Location

Site DE49003

Großhansdorf, 22977, Germany

Location

Site DE49001

Heidelberg, 69126, Germany

Location

Site DE49002

Hemer, 58675, Germany

Location

Site DE49009

Homburg/Saar, 66421, Germany

Location

Site DE49006

Immenhausen, 34376, Germany

Location

Site DE49012

Karlsruhe, 76137, Germany

Location

Site DE49015

Kassel, 34125, Germany

Location

Site DE49010

Lübeck, 23538, Germany

Location

Site DE49013

Mainz, 55131, Germany

Location

Site DE49005

Minden, 32429, Germany

Location

Site PL48002

Elblag, 82-300, Poland

Location

Site PL48005

Szczecin, 70-891, Poland

Location

Site PL48008

Torun, 87-100, Poland

Location

Site PL48006

Wroclaw, 53-439, Poland

Location

Site RO40005

Alba Iulia, 510077, Romania

Location

Site RO40001

Baia Mare, 490110, Romania

Location

Site RO40007

Brasov, 500366, Romania

Location

Site RO40002

Cluj-Napoca, 400015, Romania

Location

Site RO40003

Cluj-Napoca, 400015, Romania

Location

Site RO40006

Craiova, 200535, Romania

Location

Site RO40004

Hunedoara, 331057, Romania

Location

Site RU70002

Chelaybinsk, 454087, Russia

Location

Site RU70010

Kazan', 420029, Russia

Location

Site RU70007

Saint Petersburg, 194291, Russia

Location

Site RU70009

Saint Petersburg, 197089, Russia

Location

Site RU70011

Saint Petersburg, 197089, Russia

Location

Site KR82007

Busan, 602-715, South Korea

Location

Site KR82006

Hwasun, 519-809, South Korea

Location

Site KR82008

Incheon, 400-711, South Korea

Location

Site KR82004

Seongnam-si, 463-707, South Korea

Location

Site KR82003

Seoul, 120-752, South Korea

Location

Site KR82005

Seoul, 135-710, South Korea

Location

Site KR82002

Seoul, 137-701, South Korea

Location

Site KR82001

Suwon, South Korea

Location

Site GB44007

Bristol, BS2 8ED, United Kingdom

Location

Site GB44006

Dundee, DD1 9SY, United Kingdom

Location

Site GB44003

Leeds, LS9 7TF, United Kingdom

Location

Site GB44002

Leicester, LE1 5WW, United Kingdom

Location

Site GB44005

London, NW1 2PQ, United Kingdom

Location

Site GB44001

Manchester, M20 4BX, United Kingdom

Location

Site GB44004

Southampton, SO16 6YD, United Kingdom

Location

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

3-(8-amino-1-(2-phenylquinolin-7-yl)imidazo(1,5-a)pyrazin-3-yl)-1-methylcyclobutanol; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Medical Director

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 23, 2010
• Study Start: March 4, 2011
• Primary Completion: July 1, 2013
• Study Completion: March 11, 2015
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (8); PL (4); GB (7); BR (14); RU (5); DE (13); US (7); RO (7); CA (4)