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

NCT01630733 | Completed Phase 3 DMC

• 2 other identifiers: TV1011-LC-3032012-002447-14
• Study Type: interventional
• Target: 664
• Locations: 14 countries
• Sites: 78

Brief 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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Metastatic; Stage IV; Advanced; Lung cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

• 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.

  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)

Study Arms (2)

Custirsen + Docetaxel

EXPERIMENTAL

Custirsen: 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.

Drug: Custirsen; Drug: Docetaxel

Docetaxel

ACTIVE COMPARATOR

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.

Drug: Docetaxel

Interventions

Custirsen DRUG

Also known as: OGX-011, TV-1011

Custirsen + Docetaxel

Docetaxel DRUG

Custirsen + Docetaxel; Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Achieve Life Sciences: lead

Study Sites (78)

University Cancer Institute

Boynton Beach, Florida, United States

Location

Florida Hospital

Orlando, Florida, United States

Location

University Cancer and Blood Center, LLC

Athens, Georgia, United States

Location

Joliet Oncology-Hematology Associates Ltd.

Joliet, Illinois, United States

Location

Kentucky Cancer Clinic

Hazard, Kentucky, 33426, United States

Location

Missouri Baptist Cancer Center

St Louis, Missouri, United States

Location

Novant Health

Winston-Salem, North Carolina, United States

Location

Summa Health System

Akron, Ohio, United States

Location

Aultman Hospital

Canton, Ohio, United States

Location

Center for Biomedical Research LLC

Knoxville, Tennessee, United States

Location

Sarah Cannon Cancer Center

Nashville, Tennessee, United States

Location

Blood and Cancer Center of East Texas

Tyler, Texas, United States

Location

Tyler Hematology/Oncology PA

Tyler, Texas, United States

Location

Virginia Cancer Specialists (Leesburg) - USOR

Fairfax, Virginia, 22031, United States

Location

Border Medical Oncology

Wodonga, Victoria, Australia

Location

Austin Health

Heidelberg, Australia

Location

Royal Hobart Hospital

Hobart, Australia

Location

St George Hospital

Kogarah, Australia

Location

Cabrini Hospital Malvern

Malvern, Australia

Location

Port Macquarie Base Hospital

Port Macquarie, Australia

Location

Burnside War Memorial Hospital

Toorak Gardens, Australia

Location

Kliniken der Stadt Koln gGmbH

Cologne, Germany

Location

Asklepios Fachkliniken GmbH

Gauting, Germany

Location

Krankenhaus Martha Maria Halle Dölau gGmbH

Halle, Germany

Location

Kath. Marienkrankenhaus gGmbH

Hamburg, Germany

Location

Klinikum Kassel

Kassel, Germany

Location

Orszagos Koranyi Pulmonologiai Intezet

Budapest, Hungary

Location

Uzsoki Utcai Korhaz

Budapest, Hungary

Location

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

Szolnok, Hungary

Location

Hadassah University Hospital Ein Kerem

Jerusalem, Israel

Location

Meir Medical Center

Kfar Saba, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Assaf Harofe Medical Center

Yizre‘el, Israel

Location

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

Ancona, Italy

Location

ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, Italy

Location

Istituto Nazionale Per La Ricerca Sul Cancro

Genova, Italy

Location

Ospedale Livorno

Livorno, Italy

Location

ASST di Cremona - Azienda Socio Sanitaria Territoriale di Cremona

Lombardia, Italy

Location

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

Milan, Italy

Location

ASST Santi Paolo e Carlo - Ospedale San Carlo Borromeo

Milan, Italy

Location

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Italy

Location

Christchurch Hospital

Christchurch, New Zealand

Location

Palmerston North Hospital

Palmerston North, New Zealand

Location

Tauranga Hospital

Tauranga, New Zealand

Location

Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie

Olsztyn, Poland

Location

Med-Polonia Sp. z o.o.

Poznan, Poland

Location

Arkhangelsk Regional Clinical Oncology Dispensary

Arkhangelsk, Russia

Location

Federal State Institution Medical Radiology Research Center

Obninsk, Russia

Location

Leningrad Regional Clinical Hospital

Saint Petersburg, Russia

Location

Oncology Centre #2

Sochi, Russia

Location

Regional Clinical Oncology Hospital

Yaroslavl, Russia

Location

Kosin University Gospel Hospital

Busan, South Korea

Location

Gachon University Gil Hospital

Incheon, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Samsung Medical Center - PPDS

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Hospital Universitario Fundación Alcorcón

Alcorcón, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Complejo Hospitalario Universitario Insular-Materno Infantil

Las Palmas de Gran Canaria, Spain

Location

Consorcio Hospitalario Provincial de Castellon

Las Palmas de Gran Canaria, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda-Madrid, Spain

Location

Corporacio Sanitaria Parc Tauli

Sabadell, Spain

Location

Hospital Universitario Doctor Peset

Valencia, Spain

Location

China Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Songklanagarind Hospital Prince of Songkla University

Hat Yai, Songkhla, Thailand

Location

National Cancer Institute

Phayathai, Bangkok, Thailand

Location

Buddhachinnaraj Hospital

Phisanulok, Thailand

Location

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

Dnipropetrovsk, Ukraine

Location

Municipal Noncommercial Institution Regional Center of Oncology

Kharkiv, Ukraine

Location

Treatment and Prevention Institution Volyn Regional Oncology Dispensary

Lutsk, Ukraine

Location

Treatment and Diagnostics center of LLC Center of Clinical Diagnostics

Simferopol, Ukraine

Location

Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

Sumy, Ukraine

Location

Central City Clinical Hospital

Uzhhorod, Ukraine

Location

Vinnytsya Regional Clinical Oncology Dispensary

Vinnytsia, Ukraine

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis; Lung Neoplasms

Interventions

OGX-011; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Joachim Von Pawel, MD

  Asklepios Fachkliniken GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: June 28, 2012
• Study Start: October 24, 2012
• Primary Completion: November 17, 2016
• Study Completion: November 17, 2016
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

PL (2); HU (3); DE (5); KR (6); TW (3); UA (7); US (14); RU (5); IL (4); NZ (3); ES (8); TH (3); IT (8); AU (7)