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NSCLCPhase 2NCT01221077

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

A Phase 2 study testing OSI-906 and Erlotinib in people with NSCLC and Non Small Cell Lung Cancer, run by Astellas Pharma Inc at 29 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC, Non Small Cell Lung Cancer
What is being tested?
OSI-906 and Erlotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
29 sitesin 6 countries
Study dates
8 Apr 2011to 1 Sep 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.
  • Female subject must not donate ova starting at Screening and throughout the study period and for 30 days after final study drug administration.
  • Male subject 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. 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.
  • Male subjects must not donate sperm starting at Screening and throughout the study period and for at least 30 days after final study drug administration.
  • Patients must provide written informed consent to participate in the study
  • Patients may not have received chemotherapy for advanced NSCLC. Previous adjuvant and/or neoadjuvant treatment for NSCLC is permitted
  • Prior radiation therapy is permitted provided patients have recovered from the 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 done >= 28 days prior to randomization and adequate wound healing has occurred prior to randomization

Who cannot join

  • 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
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  • 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

Trial locations and contacts

29 sites in 6 countries.

29 sites in 6 countries

United States13 sites

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21231

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • University of California, San Diego/Moores Cancer Center

    La Jolla, California, 92093

  • University of Tennessee Cancer Institute

    Memphis, Tennessee, 31804

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Seattle Cancer Care Alliance University of Washington

    Seattle, Washington, 98109

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

  • Cleveland Clinic Florida

    Weston, Florida, 33331

Other trials in United States

South Korea5 sites

  • Chonnam National University Hwasun Hospital

    Ilsimri, Hwasun-gun, 519809

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707

  • Samsung Medical Center

    Seoul, 135710

  • Korea University Anam Hospital

    Seoul, 136705

  • Asan Medical Center

    Songpa-gu, Seoul, 138736

Other trials in South Korea

Canada4 sites

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Thailand4 sites

  • Maharaj Nakorn Chiangmai

    Chiang Mai, 50002

  • Khon Kaen University

    Khon Kaen, 40002

  • National Cancer Institute

    Phayathai, Bangkok, 10400

  • Songklanagarind Hospital, Prince of Songkla University

    Songkhla, 90110

Other trials in Thailand

Singapore2 sites

  • Oncocare Cancer Center

    Singapore, 258499

  • Johns Hopkins Singapore International Medical Centre

    Singapore, 308433

Other trials in Singapore

Hong Kong1 site

  • Pamela Youde Nethersole Eastern Hospital

    Chai Wan, 852

Other trials in Hong Kong

About this study

Official title: A Randomized, Double-Blind, Phase 2 Study of Erlotinib (Tarceva®) in Combination With OSI-906 or Placebo in Chemonaive Patients With Advanced NSCLC With Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene

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.

Read the detailed description

Based on the recommendation of the Data Monitoring Committee, OSI-906 and matching placebo are no longer being administered as of 01 March 2013.

This is a multi-center, randomized (1:1), double-blind, placebo-controlled, phase 2 study. Patients will be stratified according to the following 2 parameters: (1) EGFR activating mutation type (exon 19 deletion versus exon 21 single point mutation); and (2) Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1).

Being tested
OSI-906, Erlotinib, Placebo
Keywords
NSCLC, Epidermal Growth Factor Receptor, EGFR, Non-small cell lung cancer, Tarceva, Activating mutations, OSI-906, Chemonaive, IGF-IR, Erlotinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OSI-906Drug

    As of 01 March 2013, OSI-906 is no longer being administered

  • ErlotinibDrug

    Also called OSI-774, Tarceva

    Erlotinib administered orally

  • PlaceboDrug

    As of 01 March 2013, the matching placebo is no longer being administered

Study groups in NCT01221077
Study groupRoleWhat they receive
Arm A: Erlotinib plus OSI-906ExperimentalAs of 01 March 2013, OSI-906 is no longer being administered
Receives: Drug: OSI-906; Drug: Erlotinib
Arm B: Erlotinib plus PlaceboPlacebo comparatorAs of 01 March 2013, the matching placebo is no longer being administered
Receives: Drug: Erlotinib; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival of OSI-906 in combination with Erlotinib or Erlotinib plus placebo

    Time from randomization to disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by investigator or death due to any cause, whichever occurs first.

    Measured: 15 months

Secondary outcomes (5)

  1. Overall Survival (OS)

    Time from the date of randomization until the documented date of death.

    Measured: 33 months

  2. Disease Control Rate (DCR)

    Proportion of patients with a best overall response of complete response (CR), partial response (PR), or stable disease based on RECIST version 1.1 criteria.

    Measured: 33 months

  3. Best Overall Response Rate

    Measured: 33 months

  4. Duration of Response (CR/PR)

    Time from the date of the first documented response (CR/PR) to documented progression or death due to underlying cancer.

    Defined for patients whose best overall response was CR or PR.

    Measured: 33 months

  5. Safety assessed through evaluation of adverse events, laboratory, physical examination, and Electrocardiogram (ECG) data

    Measured: 33 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2010 (estimated)
  2. Study start8 Apr 2011
  3. Primary completion1 Mar 2013
  4. Study completion1 Sep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01221077
Sponsor's protocol ID
OSI-906-207
Status last verified
Nov 2025
First submitted
5 Oct 2010
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OSI-906 and Erlotinib in people with NSCLC and Non Small Cell Lung Cancer, run by Astellas Pharma Inc at 29 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 35 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, South Korea, Canada, Thailand, Singapore and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival of OSI-906 in combination with Erlotinib or Erlotinib plus placebo (time frame: 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01221077.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.

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