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Lung cancer drug cocktail aims to extend life

NCT ID NCT01630733

Disease control Sponsor: Achieve Life Sciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 3 trial tested whether adding custirsen to the chemotherapy drug docetaxel helps people with advanced non-small cell lung cancer live longer. The study involved 664 patients who had already tried one platinum-based treatment. Researchers compared survival between those getting the combo and those getting docetaxel alone.

What this could mean

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

Active substance
custirsen (a drug) combined with docetaxel (chemotherapy)
What this could lead to
If successful, this combination could offer a new second-line treatment option for advanced lung cancer, potentially extending survival.
What could go wrong
This is a completed Phase 3 trial, but results may not show a significant survival benefit. The combination may also increase side effects without improving outcomes.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

664 people

The number who actually took part.

Started

Oct 2012

Finished

Nov 2016

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: 1. 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). 2. Males or females ≥ 18 years of age at screening. 3. Life expectancy of \> 12 weeks from screening, according to the investigator's assessment. 4. 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. 5. Patients must have documented radiological disease progression either during or after the first-line therapy. 6. Patients must have at least one measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening. 8. 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. 9. 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). 10. Females of child-bearing potential must have negative serum pregnancy test within 72 hours before randomization. 11. 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. 12. 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. Exclusion Criteria: 1. Patients treated with any systemic anti-cancer therapy for NSCLC within 21 days prior to randomization (6 weeks for bevacizumab). 2. Radiotherapy ≤ 2 weeks prior to randomization. Patients must have recovered from all radiotherapy-related toxicities. 3. Major surgical procedure within 4 weeks prior to randomization. Patient must have recovered from all surgery-related complications. 4. 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). 5. 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). 6. 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. 7. 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. 8. Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device. Concomitant participation in observational studies is acceptable. 9. Female patients who are breastfeeding. 10. Patients previously treated with docetaxel for NSCLC or with known severe hypersensitivity to taxane therapies. 11. Patients with known and documented epidermal growth factor receptor (EGFR) mutation who have not received an EGFR inhibitor.

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Conditions

The condition(s) this trial relates to.

lung neoplasm Neoplasm Metastasis 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

Contacts and locations

Locations

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

    Milan, Italy

  • ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, Italy

  • ASST Santi Paolo e Carlo - Ospedale San Carlo Borromeo

    Milan, Italy

  • ASST di Cremona - Azienda Socio Sanitaria Territoriale di Cremona

    Lombardia, Italy

  • Arkhangelsk Regional Clinical Oncology Dispensary

    Arkhangelsk, Russia

  • Asklepios Fachkliniken GmbH

    Gauting, Germany

  • Assaf Harofe Medical Center

    Yizre‘el, Israel

  • Aultman Hospital

    Canton, Ohio, United States

  • Austin Health

    Heidelberg, Australia

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

    Ancona, Italy

  • Blood and Cancer Center of East Texas

    Tyler, Texas, United States

  • Border Medical Oncology

    Wodonga, Victoria, Australia

  • Buddhachinnaraj Hospital

    Phisanulok, Thailand

  • Burnside War Memorial Hospital

    Toorak Gardens, Australia

  • Cabrini Hospital Malvern

    Malvern, Australia

  • Center for Biomedical Research LLC

    Knoxville, Tennessee, United States

  • Central City Clinical Hospital

    Uzhhorod, Ukraine

  • China Medical University Hospital

    Taichung, Taiwan

  • Christchurch Hospital

    Christchurch, New Zealand

  • Complejo Hospitalario Universitario Insular-Materno Infantil

    Las Palmas de Gran Canaria, Spain

  • Consorcio Hospitalario Provincial de Castellon

    Las Palmas de Gran Canaria, Spain

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Spain

  • Federal State Institution Medical Radiology Research Center

    Obninsk, Russia

  • Florida Hospital

    Orlando, Florida, United States

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    Pavia, Italy

  • Gachon University Gil Hospital

    Incheon, South Korea

  • Hadassah University Hospital Ein Kerem

    Jerusalem, Israel

  • Hospital Universitario Doctor Peset

    Valencia, Spain

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Spain

  • Hospital Universitario La Paz

    Madrid, Spain

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda-Madrid, Spain

  • Hospital del Mar

    Barcelona, Spain

  • Istituto Nazionale Per La Ricerca Sul Cancro

    Genova, Italy

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

    Szolnok, Hungary

  • Joliet Oncology-Hematology Associates Ltd.

    Joliet, Illinois, United States

  • Kath. Marienkrankenhaus gGmbH

    Hamburg, Germany

  • Kentucky Cancer Clinic

    Hazard, Kentucky, 33426, United States

  • Kliniken der Stadt Koln gGmbH

    Cologne, Germany

  • Klinikum Kassel

    Kassel, Germany

  • Korea University Anam Hospital

    Seoul, South Korea

  • Kosin University Gospel Hospital

    Busan, South Korea

  • Krankenhaus Martha Maria Halle Dölau gGmbH

    Halle, Germany

  • Leningrad Regional Clinical Hospital

    Saint Petersburg, Russia

  • Med-Polonia Sp. z o.o.

    Poznan, Poland

  • Meir Medical Center

    Kfar Saba, Israel

  • Missouri Baptist Cancer Center

    St Louis, Missouri, United States

  • Municipal Noncommercial Institution Regional Center of Oncology

    Kharkiv, Ukraine

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

    Dnipropetrovsk, Ukraine

  • National Cancer Institute

    Phayathai, Bangkok, Thailand

  • National Cheng Kung University Hospital

    Tainan, Taiwan

  • Novant Health

    Winston-Salem, North Carolina, United States

  • Oncology Centre #2

    Sochi, Russia

  • Orszagos Koranyi Pulmonologiai Intezet

    Budapest, Hungary

  • Ospedale Livorno

    Livorno, Italy

  • Palmerston North Hospital

    Palmerston North, New Zealand

  • Port Macquarie Base Hospital

    Port Macquarie, Australia

  • Regional Clinical Oncology Hospital

    Yaroslavl, Russia

  • Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

    Sumy, Ukraine

  • Royal Hobart Hospital

    Hobart, Australia

  • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie

    Olsztyn, Poland

  • Samsung Medical Center

    Seoul, South Korea

  • Samsung Medical Center - PPDS

    Seoul, South Korea

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, United States

  • Seoul National University Bundang Hospital

    Seongnam, South Korea

  • Songklanagarind Hospital Prince of Songkla University

    Hat Yai, Songkhla, Thailand

  • St George Hospital

    Kogarah, Australia

  • Summa Health System

    Akron, Ohio, United States

  • Taichung Veterans General Hospital

    Taichung, Taiwan

  • Tauranga Hospital

    Tauranga, New Zealand

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, Israel

  • Treatment and Diagnostics center of LLC Center of Clinical Diagnostics

    Simferopol, Ukraine

  • Treatment and Prevention Institution Volyn Regional Oncology Dispensary

    Lutsk, Ukraine

  • Tyler Hematology/Oncology PA

    Tyler, Texas, United States

  • University Cancer Institute

    Boynton Beach, Florida, United States

  • University Cancer and Blood Center, LLC

    Athens, Georgia, United States

  • Uzsoki Utcai Korhaz

    Budapest, Hungary

  • Vinnytsya Regional Clinical Oncology Dispensary

    Vinnytsia, Ukraine

  • Virginia Cancer Specialists (Leesburg) - USOR

    Fairfax, Virginia, 22031, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.