Study of Erlotinib (Tarceva®) in Combination With OSI-906 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene

Completed · Phase 2 · Has a placebo group

Conditions studied: NSCLC, Non Small Cell Lung Cancer

In brief

A multicenter, randomized, double-blind, placebo-controlled, phase 2 study of Erlotinib (Tarceva®) in combination with OSI-906 in Patients with Advanced non-small cell lung cancer (NSCLC) with Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene who are Chemonaive.

Key facts

Study ID

NCT01221077

Run by

Astellas Pharma Inc

People needed

88

Starts

2011-04-08

Expected to finish

2014-09-01

Last updated by the study team

2025-11-18

Who can join

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

You may qualify if…

• Historically confirmed advanced NSCLC stages IIIB or IV
• Exon 19 deletion or exon 21 activating mutation in EGFR
• EGFR mutation status must be confirmed for participation in the study. EGFR 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 sponsor 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 for biomarker central 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 according to RECIST (version 1.1)
• ECOG performance status 0-1
• Must be able to take oral medication
• Fasting glucose <= 150 mg/dL (8.3 mmol/L). Concurrent use of non-insulinotropic anti hyperglycemic therapy is permitted if the dose has been stable for >= 4 weeks at the time of randomization
• Adequate hematopoietic, hepatic, and renal function as follows:
• Neutrophil count >= 1500/uL
• Platelet count >= 100,000/uL
• Serum creatinine <= 1.5 x Upper Limit of Normal (ULN)
• Potassium, magnesium, and calcium within normal limits (supplementation and re-testing is permitted)
• Total bilirubin <= 1.5 x ULN
• AST and ALT <= 2.5 x ULN, or <= 5 x ULN if patient has documented liver metastases
• Female subject 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 (at least 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. Acceptable forms include:
• Established use of oral, injected or implanted hormonal methods of contraception;
• Placement of an intrauterine device (IUD) or intrauterine system (IUS);
• Barrier methods of contraception: Condom OR Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
• Female subject must not be breastfeeding at Screening or during the study period and for 30 days after final study drug administration.

You may not qualify if…

• Prior exposure to agents directed at the Human Epidermal Receptor (HER) axis (eg, erlotinib, gefitinib, and cetuximab)
• Prior insulin-like growth factor -1 receptor (IGF-1R) inhibitor therapy
• Malignancies other than NSCLC within the 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)
• Diabetes mellitus currently requiring insulinotropic or insulin therapy
• Use of proton pump inhibitors such as omeprazole within 14 days prior to randomization. H2-receptor antagonists such as ranitidine are not excluded
• Symptomatic brain metastases that are not stable, require steroids, or have required radiation and/or other related treatment (i.e., anti-epileptic medication) within 21 days prior to randomization
• 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.
• History of poorly controlled gastrointestinal disorders that could affect the absorption of study drug (eg, Crohn's disease or ulcerative colitis)
• History (within last 6 months) 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 no 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 at screening
• Use of drugs that have a known risk of causing Torsades de Pointes (TdP) ('Torsades List' on www.azcert.org/medical-pros/drug-lists/bycategory.cfm) are prohibited within 14 days prior to randomization
• Use of strong/moderate CYP1A2 inhibitors such as ciprofloxacin and fluvoxamine. Other less potent CYP1A2 inhibitors/inducers are not excluded
• Use of strong/moderate CYP3A4 inhibitors and inducers
• History of cerebrovascular accident (CVA) within 6 months prior to randomization or that resulted in ongoing neurologic instability
• 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
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug
• Active infection, serious underlying medical condition (including any type of active seizure disorder within 12 months prior to randomization), symptomatic brain metastases, or serious chronic illness that would impair the ability of the patient to receive study drug

Where it is running

• University of California, San Diego/Moores Cancer Center — La Jolla, California, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Tennessee Cancer Institute — Memphis, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Swedish Cancer Institute — Seattle, Washington, United States
• Seattle Cancer Care Alliance University of Washington — Seattle, Washington, United States
• Juravinski Cancer Centre — Hamilton, Ontario, Canada
• London Regional Cancer Program — London, Ontario, Canada
• Princess Margaret Hospital — Toronto, Ontario, Canada
• Jewish General Hospital — Montreal, Quebec, Canada
• Pamela Youde Nethersole Eastern Hospital — Chai Wan, Hong Kong
• Oncocare Cancer Center — Singapore, Singapore
• Johns Hopkins Singapore International Medical Centre — Singapore, Singapore
• Chonnam National University Hwasun Hospital — Ilsimri, Hwasun-gun, South Korea
• Asan Medical Center — Songpa-gu, Seoul, South Korea
• Seoul National University Bundang Hospital — Seongnam-si, South Korea
• Samsung Medical Center — Seoul, South Korea
• Korea University Anam Hospital — Seoul, South Korea

Full record on ClinicalTrials.gov

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