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New drug combo aims to keep lung cancer in check after chemo

NCT ID NCT01186861

Disease control Sponsor: Astellas Pharma Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tested whether adding OSI-906 to erlotinib (Tarceva) as maintenance therapy could help people with advanced non-small cell lung cancer (NSCLC) who had not progressed after initial chemotherapy. The study enrolled 205 participants and compared the combination against erlotinib plus a placebo. The main goal was to see how long the cancer stayed under control (progression-free survival).

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OSI-906 and erlotinib (Tarceva)
What this could lead to
If successful, this combination could offer a new maintenance option to delay cancer progression in patients with advanced lung cancer who have responded to initial chemotherapy.
What could go wrong
This is a Phase 2 trial with a relatively small number of participants (205). The results may not show a significant benefit over erlotinib alone, and side effects from the drug combination could be challenging.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

205 people

The number who actually took part.

Started

Mar 2011

Finished

Mar 2015

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer (NSCLC) with nonprogression following 4 cycles of platinum-based chemotherapy

Contacts and locations

Locations

  • Site BR55001

    Itajaí, 88301-220, Brazil

  • Site BR55002

    Rio de Janeiro, 20231-050, Brazil

  • Site BR55003

    Fortaleza, 60336-550, Brazil

  • Site BR55004

    Brasília, 70840-050, Brazil

  • Site BR55005

    Barretos, 14784-400, Brazil

  • Site BR55006

    Ijuí, 98700-000, Brazil

  • Site BR55007

    São Paulo, 01323-920, Brazil

  • Site BR55008

    Piracicaba, 13419-155, Brazil

  • Site BR55011

    Florianópolis, 88034-000, Brazil

  • Site BR55012

    Ribeirão Preto, 14515-130, Brazil

  • Site BR55013

    Porto Alegre, 90430-090, Brazil

  • Site BR55014

    Porto Alegre, 90610-000, Brazil

  • Site BR55015

    Cachoeiro de Itapemirim, 29308-014, Brazil

  • Site BR55016

    Goiânia, 74605-030, Brazil

  • Site CA11001

    Oshawa, L1G 2B9, Canada

  • Site CA11002

    Toronto, M6R 1B5, Canada

  • Site CA11004

    Ottawa, K1H 8L6, Canada

  • Site CA11006

    Toronto, M5G 1X5, Canada

  • Site DE49001

    Heidelberg, 69126, Germany

  • Site DE49002

    Hemer, 58675, Germany

  • Site DE49003

    Großhansdorf, 22977, Germany

  • Site DE49005

    Minden, 32429, Germany

  • Site DE49006

    Immenhausen, 34376, Germany

  • Site DE49008

    Cologne, 51109, Germany

  • Site DE49009

    Homburg/Saar, 66421, Germany

  • Site DE49010

    Lübeck, 23538, Germany

  • Site DE49011

    Dortmund, 44145, Germany

  • Site DE49012

    Karlsruhe, 76137, Germany

  • Site DE49013

    Mainz, 55131, Germany

  • Site DE49014

    Berlin, 10117, Germany

  • Site DE49015

    Kassel, 34125, Germany

  • Site GB44001

    Manchester, M20 4BX, United Kingdom

  • Site GB44002

    Leicester, LE1 5WW, United Kingdom

  • Site GB44003

    Leeds, LS9 7TF, United Kingdom

  • Site GB44004

    Southampton, SO16 6YD, United Kingdom

  • Site GB44005

    London, NW1 2PQ, United Kingdom

  • Site GB44006

    Dundee, DD1 9SY, United Kingdom

  • Site GB44007

    Bristol, BS2 8ED, United Kingdom

  • Site KR82001

    Suwon, South Korea

  • Site KR82002

    Seoul, 137-701, South Korea

  • Site KR82003

    Seoul, 120-752, South Korea

  • Site KR82004

    Seongnam-si, 463-707, South Korea

  • Site KR82005

    Seoul, 135-710, South Korea

  • Site KR82006

    Hwasun, 519-809, South Korea

  • Site KR82007

    Busan, 602-715, South Korea

  • Site KR82008

    Incheon, 400-711, South Korea

  • Site PL48002

    Elblag, 82-300, Poland

  • Site PL48005

    Szczecin, 70-891, Poland

  • Site PL48006

    Wroclaw, 53-439, Poland

  • Site PL48008

    Torun, 87-100, Poland

  • Site RO40001

    Baia Mare, 490110, Romania

  • Site RO40002

    Cluj-Napoca, 400015, Romania

  • Site RO40003

    Cluj-Napoca, 400015, Romania

  • Site RO40004

    Hunedoara, 331057, Romania

  • Site RO40005

    Alba Iulia, 510077, Romania

  • Site RO40006

    Craiova, 200535, Romania

  • Site RO40007

    Brasov, 500366, Romania

  • Site RU70002

    Chelaybinsk, 454087, Russia

  • Site RU70007

    Saint Petersburg, 194291, Russia

  • Site RU70009

    Saint Petersburg, 197089, Russia

  • Site RU70010

    Kazan', 420029, Russia

  • Site RU70011

    Saint Petersburg, 197089, Russia

  • Site US10001

    Port Saint Lucie, Florida, 34952, United States

  • Site US10002

    Albany, Georgia, 31701, United States

  • Site US10004

    Greensboro, North Carolina, 27403, United States

  • Site US10007

    Jacksonville, Florida, 32207, United States

  • Site US10008

    Chicago, Illinois, 60612, United States

  • Site US10010

    Winston-Salem, North Carolina, 27103, United States

  • Site US10011

    Scarborough, Maine, 04074, United States