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Non-Small Cell Lung Cancer (NSCLC) With Nonprogression Following 4 Cycles of Platinum-based ChemotherapyPhase 2NCT01186861

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

A Phase 2 study testing OSI-906 and erlotinib in people with Non-Small Cell Lung Cancer (NSCLC) With Nonprogression Following 4 Cycles of Platinum-based Chemotherapy, run by Astellas Pharma Inc at 69 sites in 9 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 with a 1:1 randomization scheme. Read more about this study

Who is it for?
Ages 18 years and older
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
205 participants
Where
69 sitesin 9 countries
Study dates
4 Mar 2011to 11 Mar 2015
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

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

69 sites in 9 countries.

69 sites in 9 countries

Brazil14 sites

  • Site BR55005

    Barretos, 14784-400

  • Site BR55004

    Brasília, 70840-050

  • Site BR55015

    Cachoeiro de Itapemirim, 29308-014

  • Site BR55011

    Florianópolis, 88034-000

  • Site BR55003

    Fortaleza, 60336-550

  • Site BR55016

    Goiânia, 74605-030

  • Site BR55006

    Ijuí, 98700-000

  • Site BR55001

    Itajaí, 88301-220

  • Site BR55008

    Piracicaba, 13419-155

  • Site BR55013

    Porto Alegre, 90430-090

  • Site BR55014

    Porto Alegre, 90610-000

  • Site BR55012

    Ribeirão Preto, 14515-130

  • Site BR55002

    Rio de Janeiro, 20231-050

  • Site BR55007

    São Paulo, 01323-920

Other trials in Brazil

Germany13 sites

  • Site DE49014

    Berlin, 10117

  • Site DE49008

    Cologne, 51109

  • Site DE49011

    Dortmund, 44145

  • Site DE49003

    Großhansdorf, 22977

  • Site DE49001

    Heidelberg, 69126

  • Site DE49002

    Hemer, 58675

  • Site DE49009

    Homburg/Saar, 66421

  • Site DE49006

    Immenhausen, 34376

  • Site DE49012

    Karlsruhe, 76137

  • Site DE49015

    Kassel, 34125

  • Site DE49010

    Lübeck, 23538

  • Site DE49013

    Mainz, 55131

  • Site DE49005

    Minden, 32429

Other trials in Germany

South Korea8 sites

  • Site KR82007

    Busan, 602-715

  • Site KR82006

    Hwasun, 519-809

  • Site KR82008

    Incheon, 400-711

  • Site KR82004

    Seongnam-si, 463-707

  • Site KR82003

    Seoul, 120-752

  • Site KR82005

    Seoul, 135-710

  • Site KR82002

    Seoul, 137-701

  • Site KR82001

    Suwon

Other trials in South Korea

United States7 sites

  • Site US10002

    Albany, Georgia, 31701

  • Site US10008

    Chicago, Illinois, 60612

  • Site US10004

    Greensboro, North Carolina, 27403

  • Site US10007

    Jacksonville, Florida, 32207

  • Site US10001

    Port Saint Lucie, Florida, 34952

  • Site US10011

    Scarborough, Maine, 04074

  • Site US10010

    Winston-Salem, North Carolina, 27103

Other trials in United States

Romania7 sites

  • Site RO40005

    Alba Iulia, 510077

  • Site RO40001

    Baia Mare, 490110

  • Site RO40007

    Brasov, 500366

  • Site RO40002

    Cluj-Napoca, 400015

  • Site RO40003

    Cluj-Napoca, 400015

  • Site RO40006

    Craiova, 200535

  • Site RO40004

    Hunedoara, 331057

Other trials in Romania

United Kingdom7 sites

  • Site GB44007

    Bristol, BS2 8ED

  • Site GB44006

    Dundee, DD1 9SY

  • Site GB44003

    Leeds, LS9 7TF

  • Site GB44002

    Leicester, LE1 5WW

  • Site GB44005

    London, NW1 2PQ

  • Site GB44001

    Manchester, M20 4BX

  • Site GB44004

    Southampton, SO16 6YD

Other trials in United Kingdom

Russia5 sites

  • Site RU70002

    Chelaybinsk, 454087

  • Site RU70010

    Kazan', 420029

  • Site RU70007

    Saint Petersburg, 194291

  • Site RU70009

    Saint Petersburg, 197089

  • Site RU70011

    Saint Petersburg, 197089

Other trials in Russia

Canada4 sites

  • Site CA11001

    Oshawa, L1G 2B9

  • Site CA11004

    Ottawa, K1H 8L6

  • Site CA11006

    Toronto, M5G 1X5

  • Site CA11002

    Toronto, M6R 1B5

Other trials in Canada

Poland4 sites

  • Site PL48002

    Elblag, 82-300

  • Site PL48005

    Szczecin, 70-891

  • Site PL48008

    Torun, 87-100

  • Site PL48006

    Wroclaw, 53-439

Other trials in Poland

About this study

Official title: A Randomized, Double-Blind, Placebo-controlled Phase 2 Study of Maintenance OSI-906 Plus Erlotinib (Tarceva®), or Erlotinib Plus Placebo in Patients With Nonprogression Following Four Cycles of 1st-line Platinum-based Chemotherapy for Advanced NSCLC

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

Read the 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.

Being tested
OSI-906, erlotinib, placebo
Keywords
OSI-906, Erlotinib, Platinum-based chemotherapy, Placebo, NSCLC
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

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

  • erlotinibDrug

    Also called OSI-774, Tarceva

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

  • placeboDrug

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

Study groups in NCT01186861
Study groupRoleWhat they receive
Arm A: OSI-906 plus erlotinibExperimentalOSI-906 150 mg twice daily (BID) starting on Day 1; erlotinib 150 mg once daily (QD) starting on Day 1
Receives: Drug: OSI-906; Drug: erlotinib
Arm B: placebo plus erlotinibPlacebo comparatorplacebo BID starting on Day 1: erlotinib 150 mg QD starting on Day 1
Receives: Drug: erlotinib; Drug: placebo

What is being measured

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

  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

    Measured: 22 months

Secondary outcomes (6)

  1. Overall survival (OS)

    The time from the date of randomization until the documented date of death

    Measured: 27 months

  2. Disease control Rate (DCR)

    The proportion of patients with a best overall response of continued Complete Response (CR), CR, Partial Response (PR), OR Stable Disease (SD) based on RECIST criteria

    Measured: 27 months

  3. Best overall response rate (ORR)

    The proportion of patients with a best overall response of CR or PR based on RECIST criteria

    Measured: 27 months

  4. Response upgrade rate (RUR)

    The proportion of patients with a response upgrade

    Measured: 27 months

  5. Duration of response

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

    Measured: 27 months

  6. Safety assessed through physical examination, vital signs, clinical laboratory tests, electrocardiograms (ECG) and Adverse Events

    Measured: 27 months

Timeline

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

  1. First posted23 Aug 2010 (estimated)
  2. Study start4 Mar 2011
  3. Primary completion1 Jul 2013
  4. Study completion11 Mar 2015

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
205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01186861
Sponsor's protocol ID
OSI-906-205
Other IDs
2010-020916-12
Status last verified
Nov 2025
First submitted
19 Aug 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 Non-Small Cell Lung Cancer (NSCLC) With Nonprogression Following 4 Cycles of Platinum-based Chemotherapy, run by Astellas Pharma Inc at 69 sites in 9 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 31 inclusion and 21 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 69 sites in Brazil, Germany, South Korea, United States, Romania and 4 more countries. 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?

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 (time frame: 22 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 NCT01186861.

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; AzTrials last refreshed its copy on 7 Nov 2026.

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