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

NCT ID: NCT01186861

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-04
• Study Completion Date: 2015-03-11

Brief Summary

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

Detailed Description

Adult patients with advanced Non-small Cell Lung Cancer (NSCLC) and nonprogression after platinum-based chemotherapy will be randomized 1:1 to receive either OSI-906 plus erlotinib or placebo plus erlotinib.

Conditions

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

Study Design

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

Study Groups

Arm A: OSI-906 plus erlotinib

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

Group Type: EXPERIMENTAL

OSI-906

Intervention Type: DRUG

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

erlotinib

Intervention Type: DRUG

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

Arm B: placebo plus erlotinib

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

Group Type: PLACEBO_COMPARATOR

erlotinib

Intervention Type: DRUG

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

placebo

Intervention Type: DRUG

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

Interventions

OSI-906

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

Intervention Type: DRUG

erlotinib

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

Intervention Type: DRUG

placebo

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

Intervention Type: DRUG

Other Intervention Names

OSI-774; Tarceva

Eligibility Criteria

Inclusion Criteria

• 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
• Potassium, magnesium and calcium within normal limits (supplementation and retesting is permitted)

Female patient must be either:

• Of non child bearing potential:

• post-menopausal (defined as at least 1 year without any menses) prior to

Screening, or

• documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening)

• Or, if of childbearing potential:
• must have a negative urine pregnancy test at Screening, and
• must use two forms of birth control (one of which must be a barrier method) starting at Screening and throughout the study period and for 30 days after final study drug administration

• Female patient must not be breastfeeding at Screening or during the study period and for 30 days after final study drug administration
• Female patient must not donate ova starting at Screening and throughout the study period and for 30 days after final study drug administration
• Male patient and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period and for 30 days after final study drug administration
• Male patient must not donate sperm starting at Screening and throughout the study period and for at least 30 days after final study drug administration
• Prior radiation therapy is permitted provided patients have recovered from acute toxic effects of radiotherapy prior to randomization. A minimum of 28 days must have elapsed between the end of radiotherapy and randomization
• Prior surgery is permitted provided that the surgery was performed 21 days prior to randomization and adequate wound healing has occurred prior to randomization
• Patients must provide written (signed) informed consent to participate in the study and for use of tumor tissues

Exclusion Criteria

• 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
• Active infection, serious underlying medical condition (including any type of active seizure disorder within 12 months prior to randomization), or serious chronic illness that would impair the ability of the patient to receive study drug
• History of any psychiatric or neurologic condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent
• Pregnant or breast-feeding females
• Symptomatic brain metastases that are not stable, require steroids, or that have required radiation and/or other related treatment (e.g., anti-epileptic medication) within 21 days prior to randomization
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drug
• Participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives whichever is longer, prior to the initiation of Screening or during the course of the study

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

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Global Development

Locations

Site US10007

Jacksonville, Florida, United States

Site US10001

Port Saint Lucie, Florida, United States

Site US10002

Albany, Georgia, United States

Site US10008

Chicago, Illinois, United States

Site US10011

Scarborough, Maine, United States

Site US10004

Greensboro, North Carolina, United States

Site US10010

Winston-Salem, North Carolina, United States

Site BR55005

Barretos, , Brazil

Site BR55004

Brasília, , Brazil

Site BR55015

Cachoeiro de Itapemirim, , Brazil

Site BR55011

Florianópolis, , Brazil

Site BR55003

Fortaleza, , Brazil

Site BR55016

Goiânia, , Brazil

Site BR55006

Ijuí, , Brazil

Site BR55001

Itajaí, , Brazil

Site BR55008

Piracicaba, , Brazil

Site BR55013

Porto Alegre, , Brazil

Site BR55014

Porto Alegre, , Brazil

Site BR55012

Ribeirão Preto, , Brazil

Site BR55002

Rio de Janeiro, , Brazil

Site BR55007

São Paulo, , Brazil

Site CA11001

Oshawa, , Canada

Site CA11004

Ottawa, , Canada

Site CA11006

Toronto, , Canada

Site CA11002

Toronto, , Canada

Site DE49014

Berlin, , Germany

Site DE49008

Cologne, , Germany

Site DE49011

Dortmund, , Germany

Site DE49003

Großhansdorf, , Germany

Site DE49001

Heidelberg, , Germany

Site DE49002

Hemer, , Germany

Site DE49009

Homburg/Saar, , Germany

Site DE49006

Immenhausen, , Germany

Site DE49012

Karlsruhe, , Germany

Site DE49015

Kassel, , Germany

Site DE49010

Lübeck, , Germany

Site DE49013

Mainz, , Germany

Site DE49005

Minden, , Germany

Site PL48002

Elblag, , Poland

Site PL48005

Szczecin, , Poland

Site PL48008

Torun, , Poland

Site PL48006

Wroclaw, , Poland

Site RO40005

Alba Iulia, , Romania

Site RO40001

Baia Mare, , Romania

Site RO40007

Brasov, , Romania

Site RO40002

Cluj-Napoca, , Romania

Site RO40003

Cluj-Napoca, , Romania

Site RO40006

Craiova, , Romania

Site RO40004

Hunedoara, , Romania

Site RU70002

Chelaybinsk, , Russia

Site RU70010

Kazan', , Russia

Site RU70007

Saint Petersburg, , Russia

Site RU70009

Saint Petersburg, , Russia

Site RU70011

Saint Petersburg, , Russia

Site KR82007

Busan, , South Korea

Site KR82006

Hwasun, , South Korea

Site KR82008

Incheon, , South Korea

Site KR82004

Seongnam-si, , South Korea

Site KR82003

Seoul, , South Korea

Site KR82005

Seoul, , South Korea

Site KR82002

Seoul, , South Korea

Site KR82001

Suwon, , South Korea

Site GB44007

Bristol, , United Kingdom

Site GB44006

Dundee, , United Kingdom

Site GB44003

Leeds, , United Kingdom

Site GB44002

Leicester, , United Kingdom

Site GB44005

London, , United Kingdom

Site GB44001

Manchester, , United Kingdom

Site GB44004

Southampton, , United Kingdom

Countries

United States; Brazil; Canada; Germany; Poland; Romania; Russia; South Korea; United Kingdom

Related Links

https://astellasclinicalstudyresults.com/study.aspx?ID=229

Link to results on the Astellas Clinical Study Results website

Other Identifiers

2010-020916-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

OSI-906-205

Identifier Type: -

Identifier Source: org_study_id