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Non-Small Cell Lung CancerPhase 3ENSPIRITNCT01630733

A Multinational, Randomized, Open-Label Study of Custirsen In Patients With Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer

A Phase 3 study testing Custirsen and Docetaxel in people with Non-Small Cell Lung Cancer, run by Achieve Life Sciences at 78 sites in 14 countries.

Completed

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

Official record
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Trial summary

The primary objective of the study is to compare overall survival of participants randomized to receiving custirsen in combination with docetaxel with participants randomized to receive docetaxel alone. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Custirsen and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
664 participants
Where
78 sitesin 14 countries
Study dates
24 Oct 2012to 17 Nov 2016
Phase
Phase 3
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

  • Patients must have a histologically or cytologically confirmed, unresectable, advanced or metastatic (Stage IV per American Joint Committee on Cancer 7th edition Tumor size, lymph Nodes affected, Metastases staging) non-small cell lung cancer (NSCLC).
  • Males or females ≥ 18 years of age at screening.
  • Life expectancy of > 12 weeks from screening, according to the investigator's assessment.
  • Patients must have received one prior line of platinum-based systemic anticancer therapy for advanced or metastatic NSCLC. Prior maintenance therapy is allowed and will be considered as the same line of therapy when continued at the end of a treatment regimen.
  • Patients must have documented radiological disease progression either during or after the first-line therapy.
  • Patients must have at least one measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria.
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.
  • Have adequate values, bone marrow, renal and liver functions at screening as defined below:
  • Absolute neutrophil count ≥ 1.5 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Hemoglobin ≥ 9 g/dL
  • Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
  • Total Bilirubin ≤ 1.0 x ULN (unless elevated secondary to benign conditions such as Gilbert's disease)
  • Aspartate aminotransferase and alanine aminotransferase ≤ 1.5 x ULN.
  • Resolution of any toxic effects of prior therapy to Grade ≤1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (exception of alopecia and ≤ Grade 2 peripheral neuropathy).
  • Females of child-bearing potential must have negative serum pregnancy test within 72 hours before randomization.
  • Women of child-bearing potential will practice a highly effective method of birth control during and for 3 months after the chemotherapy/custirsen last dose. Men of reproductive potential who are not surgically sterile must agree to abstain from sexual activity or use medically accepted and highly effective method of contraception during and for 6 months after the chemotherapy/custirsen last dose.
  • Patients must be willing and able to give written informed consent prior to any protocol-specific procedures being performed and comply with the protocol requirements for the duration of the study.

Who cannot join

  • Patients treated with any systemic anti-cancer therapy for NSCLC within 21 days prior to randomization (6 weeks for bevacizumab).
  • Radiotherapy ≤ 2 weeks prior to randomization. Patients must have recovered from all radiotherapy-related toxicities.
  • Major surgical procedure within 4 weeks prior to randomization. Patient must have recovered from all surgery-related complications.
  • Patients with known central nervous system (CNS) metastases (patients with any clinical signs of CNS metastases must have a computed tomography or magnetic resonance imaging of the brain to rule out CNS metastases in order to be eligible for participation in the study). Patients who have had brain metastases treated with radiotherapy or surgically removed with no residual disease confirmed by imaging; patients should be clinically stable and off corticosteroid treatment at least 3 weeks prior to randomization).
  • Patients with current diagnosis or a history of another active primary malignancy (except in situ carcinoma of the cervix, adequately treated non-melanomatous skin cancers, clinically localized prostate cancer, superficial bladder cancer or other malignancy treated at least 5 years previously with no evidence of recurrence).
  • Severe or unstable medical conditions such as heart failure, ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, psychiatric condition, as well as an ongoing cardiac arrhythmia requiring medication (≥ Grade 2, according to NCI CTCAE v4.0) or any other significant or unstable concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy.
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  • A history of events such as myocardial infarction, cerebrovascular accident or acute hepatitis within 3 months of randomization or treatment of a major active infection within one month of randomization, or any other significant event that in the opinion of the Investigator would preclude protocol therapy.
  • Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device. Concomitant participation in observational studies is acceptable.
  • Female patients who are breastfeeding.
  • Patients previously treated with docetaxel for NSCLC or with known severe hypersensitivity to taxane therapies.
  • Patients with known and documented epidermal growth factor receptor (EGFR) mutation who have not received an EGFR inhibitor.

Trial locations and contacts

78 sites in 14 countries.

78 sites in 14 countries

United States14 sites

  • Summa Health System

    Akron, Ohio

  • University Cancer and Blood Center, LLC

    Athens, Georgia

  • University Cancer Institute

    Boynton Beach, Florida

  • Aultman Hospital

    Canton, Ohio

  • Virginia Cancer Specialists (Leesburg) - USOR

    Fairfax, Virginia, 22031

  • Kentucky Cancer Clinic

    Hazard, Kentucky, 33426

  • Joliet Oncology-Hematology Associates Ltd.

    Joliet, Illinois

  • Center for Biomedical Research LLC

    Knoxville, Tennessee

  • Sarah Cannon Cancer Center

    Nashville, Tennessee

  • Florida Hospital

    Orlando, Florida

  • Missouri Baptist Cancer Center

    St Louis, Missouri

  • Blood and Cancer Center of East Texas

    Tyler, Texas

  • Tyler Hematology/Oncology PA

    Tyler, Texas

  • Novant Health

    Winston-Salem, North Carolina

Other trials in United States

Italy8 sites

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi

    Ancona

  • ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo

  • Istituto Nazionale Per La Ricerca Sul Cancro

    Genova

  • Ospedale Livorno

    Livorno

  • ASST di Cremona - Azienda Socio Sanitaria Territoriale di Cremona

    Lombardia

  • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

    Milan

  • ASST Santi Paolo e Carlo - Ospedale San Carlo Borromeo

    Milan

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    Pavia

Other trials in Italy

Spain8 sites

  • Hospital Universitario Fundación Alcorcón

    Alcorcón

  • Hospital del Mar

    Barcelona

  • Complejo Hospitalario Universitario Insular-Materno Infantil

    Las Palmas de Gran Canaria

  • Consorcio Hospitalario Provincial de Castellon

    Las Palmas de Gran Canaria

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda-Madrid

  • Corporacio Sanitaria Parc Tauli

    Sabadell

  • Hospital Universitario Doctor Peset

    Valencia

Other trials in Spain

Australia7 sites

  • Austin Health

    Heidelberg

  • Royal Hobart Hospital

    Hobart

  • St George Hospital

    Kogarah

  • Cabrini Hospital Malvern

    Malvern

  • Port Macquarie Base Hospital

    Port Macquarie

  • Burnside War Memorial Hospital

    Toorak Gardens

  • Border Medical Oncology

    Wodonga, Victoria

Other trials in Australia

Ukraine7 sites

  • Municipal institution Multifield City Clinical Hospital Numero 4 of Dnipropetrovsk Regional Council

    Dnipropetrovsk

  • Municipal Noncommercial Institution Regional Center of Oncology

    Kharkiv

  • Treatment and Prevention Institution Volyn Regional Oncology Dispensary

    Lutsk

  • Treatment and Diagnostics center of LLC Center of Clinical Diagnostics

    Simferopol

  • Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

    Sumy

  • Central City Clinical Hospital

    Uzhhorod

  • Vinnytsya Regional Clinical Oncology Dispensary

    Vinnytsia

Other trials in Ukraine

South Korea6 sites

  • Kosin University Gospel Hospital

    Busan

  • Gachon University Gil Hospital

    Incheon

  • Seoul National University Bundang Hospital

    Seongnam

  • Korea University Anam Hospital

    Seoul

  • Samsung Medical Center - PPDS

    Seoul

  • Samsung Medical Center

    Seoul

Other trials in South Korea

Germany5 sites

  • Kliniken der Stadt Koln gGmbH

    Cologne

  • Asklepios Fachkliniken GmbH

    Gauting

  • Krankenhaus Martha Maria Halle Dölau gGmbH

    Halle

  • Kath. Marienkrankenhaus gGmbH

    Hamburg

  • Klinikum Kassel

    Kassel

Other trials in Germany

Russia5 sites

  • Arkhangelsk Regional Clinical Oncology Dispensary

    Arkhangelsk

  • Federal State Institution Medical Radiology Research Center

    Obninsk

  • Leningrad Regional Clinical Hospital

    Saint Petersburg

  • Oncology Centre #2

    Sochi

  • Regional Clinical Oncology Hospital

    Yaroslavl

Other trials in Russia

Israel4 sites

  • Hadassah University Hospital Ein Kerem

    Jerusalem

  • Meir Medical Center

    Kfar Saba

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

  • Assaf Harofe Medical Center

    Yizre‘el

Other trials in Israel

Hungary3 sites

  • Orszagos Koranyi Pulmonologiai Intezet

    Budapest

  • Uzsoki Utcai Korhaz

    Budapest

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

    Szolnok

Other trials in Hungary

New Zealand3 sites

  • Christchurch Hospital

    Christchurch

  • Palmerston North Hospital

    Palmerston North

  • Tauranga Hospital

    Tauranga

Other trials in New Zealand

Taiwan3 sites

  • China Medical University Hospital

    Taichung

  • Taichung Veterans General Hospital

    Taichung

  • National Cheng Kung University Hospital

    Tainan

Other trials in Taiwan

Thailand3 sites

  • Songklanagarind Hospital Prince of Songkla University

    Hat Yai, Songkhla

  • National Cancer Institute

    Phayathai, Bangkok

  • Buddhachinnaraj Hospital

    Phisanulok

Other trials in Thailand

Poland2 sites

  • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie

    Olsztyn

  • Med-Polonia Sp. z o.o.

    Poznan

Other trials in Poland

About this study

Official title: A Multinational, Randomized, Open-Label Phase III Study of Custirsen (TV-1011/OGX-011) In Combination With Docetaxel Versus Docetaxel As A Second-Line Treatment In Patients With Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer

The primary objective of the study is to compare overall survival of participants randomized to receiving custirsen in combination with docetaxel with participants randomized to receive docetaxel alone.

Being tested
Custirsen, Docetaxel
Keywords
Metastatic, Stage IV, Advanced, Lung cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Lung Neoplasms

What participants receive

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

  • CustirsenDrug

    Also called OGX-011, TV-1011

  • DocetaxelDrug

Study groups in NCT01630733
Study groupRoleWhat they receive
Custirsen + DocetaxelExperimentalCustirsen: Three loading doses of custirsen 640 mg intravenously (IV) over 2 hours administered in 5 to 9 days prior to Day 1 of Cycle 1, then custirsen 640 mg IV weekly every 21-day cycle. Docetaxel: 75 mg/m^2 IV over 1 hour on Day 1 of every 21-day cycle. Continue treatment until disease progression, unacceptable toxicity, withdrawal of consent, or protocol-specified parameters to stop.
Receives: Drug: Custirsen; Drug: Docetaxel
DocetaxelActive comparatorDocetaxel: 75 mg/m^2 IV over 1 hour on Day 1 of every 21-day cycle. Continue treatment until disease progression, unacceptable toxicity, withdrawal of consent, or protocol-specified parameters to stop.
Receives: Drug: Docetaxel

What is being measured

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

  1. Overall Survival: All Randomized Population

    Overall survival time is defined as the number of days from the date of randomization until the date of death from any cause. Participants who did not achieve the event (death) at the time of the analysis or who dropped out before completing the survival follow-up period will be censored at the date they were last known to be alive (i.e., right censored). Partial or missing dates of death or last contact were imputed.

    Measured: From randomization to death or last known date alive (up to 1331 days for Docetaxel arm and up to 1271 days for Docetaxel + Custirsen arm)

  2. Overall Survival: Stratified by Histology - Squamous vs. Non-Squamous

    Overall survival time is defined as the number of days from the date of randomization until the date of death from any cause. Participants who did not achieve the event (death) at the time of the analysis or who dropped out before completing the survival follow-up period will be censored at the date they were last known to be alive (i.e., right censored). Partial or missing dates of death or last contact were imputed.

    Measured: From randomization to death or last known date alive (up to 1331 days for Docetaxel arm and up to 1271 days for Docetaxel + Custirsen arm)

Timeline

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

  1. First posted28 Jun 2012 (estimated)
  2. Study start24 Oct 2012
  3. Primary completion17 Nov 2016
  4. Study completion17 Nov 2016

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
664 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01630733
Sponsor's protocol ID
TV1011-LC-303
Other IDs
2012-002447-14
Acronym
ENSPIRIT
Status last verified
Apr 2026
First submitted
26 Jun 2012
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Custirsen and Docetaxel in people with Non-Small Cell Lung Cancer, run by Achieve Life Sciences at 78 sites in 14 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 18 inclusion and 11 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 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, Italy, Spain, Australia, Ukraine and 9 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Overall Survival: All Randomized Population (time frame: From randomization to death or last known date alive (up to 1331 days for Docetaxel arm and up to 1271 days for Docetaxel + Custirsen arm)). The study lists 2 primary outcomes in all. 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 NCT01630733.

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 15 Apr 2026.

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