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Blood test may predict which lung cancer drug works best

NCT ID NCT01652469

Disease control Sponsor: ETOP IBCSG Partners Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This trial is testing whether a blood test called VeriStrat can help choose between two drugs for people with advanced squamous non-small cell lung cancer that has progressed after initial chemotherapy. Participants are grouped by their VeriStrat result (good or poor) and then randomly assigned to receive either erlotinib (a targeted pill) or docetaxel (a chemotherapy infusion). The goal is to see if the test can predict which drug offers better progression-free survival, potentially leading to more personalized treatment.

What this could mean

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

Active substance
erlotinib (Tarceva) and docetaxel (Taxotere)
What this could lead to
If the VeriStrat test works, doctors could personalize treatment for lung cancer patients, giving them the drug most likely to help.
What could go wrong
The trial is small and early, and the test may not reliably predict benefit. Both drugs have side effects, and the study may not show a clear advantage.

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

81 people

The number who actually took part.

Start date

Aug 2012

Finished

Dec 2015

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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 or cytologically confirmed locally advanced stage IIIB, not amenable to radical radiotherapy, or metastatic stage IV non-small cell lung cancer (NSCLC) of predominant squamous subtype, according to the 7th edition of the TNM classification, including M1a (separate tumor nodule in a contralateral lobe, tumor with pleural nodules or malignant pleural or pericardial effusion) and/or M1b (distant metastasis). * Progressive disease upon or after previous chemotherapy including at least one line of platinum-based chemotherapy. * Measurable or evaluable disease according to RECIST v1.1 (Appendix 2). * ECOG PS 0-2. * Age ≥ 18 years. * Adequate organ function, including: * Adequate bone marrow reserve: ANC \> 1.5 x 109/L, platelets \> 100 x 109/L. * Hepatic: bilirubin \<1.5 x ULN; AP, ALT \< 3.0 x ULN; AP, ALT \<5 x ULN is acceptable in case of liver metastasis. * Renal: calculated creatinine clearance \> 40 ml/min based on the Cockroft and Gault formula. * Signed and dated informed consent form. * Male and female patients with reproductive potential must use an approved contraceptive method, during the trial and 12 months thereafter. Female patients with reproductive potential must have a negative pregnancy test within 7 days prior to study registration. * Estimated life expectancy \>12 weeks. * Patient compliance and geographical proximity that allow adequate follow-up. Exclusion Criteria: * Evidence of other medical condition which would impair the ability of the patient to participate in the trial or might preclude therapy with trial drugs (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease, active infection, uncontrolled diabetes mellitus). * Previous treatment with any EGFR-TKI or docetaxel. * Documented brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least 14 days prior to study registration. * Documented presence of activating EGFR mutations, if the patient was tested for EGFR mutations. * Previous malignancy within the past 5 years with the exception of adequately treated cervical carcinoma in situ, breast cancer in situ or localized non-melanoma skin cancer. * Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, or interfering with compliance for oral drug intake. * Concurrent treatment with experimental drugs or other anti-cancer therapy treatment in a clinical trial within 21 days prior to study registration. * Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs or any concomitant drugs contraindicated.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma non-small cell squamous lung carcinoma

As listed by the trial registrant

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

Carcinoma, non-small-cell lung

Contacts and locations

Locations

  • Aarhus University Hospital

    Aarhus, Denmark

  • Carlos Haya Hospital

    Málaga, Spain

  • Ciudad Real General University Hospital

    Ciudad Real, Spain

  • Fondation du centre Pluridisciplinaire d'Oncologie (CePO)

    Lausanne, 1011, Switzerland

  • Free University Medical Center

    Amsterdam, 1007 MB, Netherlands

  • Hospital 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Arnau Vilanova Valencia

    Valencia, Spain

  • Hospital Clínic Barcelona

    Barcelona, 08036, Spain

  • Hospital Clínico Universitario de Valencia

    Valencia, Spain

  • Hospital La Fe

    Valencia, Spain

  • Hospital San Pedro de Alcantara

    Cáceres, Spain

  • Hospital Severo Ochoa

    Leganés, Spain

  • Hospital Universitari Sant Joan

    Reus, Spain

  • Hospital general de Alicante

    Alicante, Spain

  • Institut Català d'Oncologia - L'Hospitalet

    Barcelona, Spain

  • Institut Jules Bordet

    Brussels, Belgium

  • Institution Rabin MC

    Petah Tikwa, Israel

  • Kantonsspital Graubünden

    Chur, Switzerland

  • Kantonsspital Luzern

    Lucerne, 6016, Switzerland

  • Krankenhaus Hietzing

    Vienna, Austria

  • Medical Oncology, Second University Naples

    Naples, Italy

  • National Institute of Oncology

    Budapest, Hungary

  • Onkologiezentrum Berner Oberland

    Thun, 3600, Switzerland

  • Onkologikoa

    Donostia / San Sebastian, Spain

  • St James's Hospital

    Dublin, Ireland

  • Tel-Aviv Medical Center

    Tel Aviv, Israel

  • University Hospital Basel

    Basel, 4031, Switzerland

  • University Hospital South Manchester

    Manchester, United Kingdom

  • University Hospital of Heraklion

    Heraklion, Greece

  • Universitätsspital Zürich

    Zurich, Switzerland

  • Vercelli Teaching Hospital

    Vercelli, Italy

  • Weston Park Hospital

    Sheffield, United Kingdom

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