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Non-Small Cell Lung CancerPhase 3NCT01183858

A Study of Tarceva (Erlotinib) to Compare Two Different Doses in in Currently Smoking Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (CURRENTS)

A Phase 3 study testing Erlotinib [Tarceva] in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 63 sites in 9 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

This prospective, double-blind, randomized study will evaluate the safety and efficacy of two dose levels of erlotinib [Tarceva] on progression-free survival, response and disease control rates and overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line… 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?
Erlotinib [Tarceva]
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
315 participants
Where
63 sitesin 9 countries
Study dates
Oct 2010to Feb 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Adult patients aged ≥18 years
  • inoperable, locally advanced (stage IIIB/IV) with supraclavicular lymph node metastases or malignant pleural or pericardial effusion) or metastatic (stage IV) non-small cell lung cancer (NSCLC)
  • Disease must be characterized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • Patients have received one prior platinum-based chemotherapy regimen for advanced NSCLC, but must have recovered from any treatment-related toxicity
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Life expectancy ≥12 weeks
  • Current cigarette smoker (having smoked >100 cigarettes in entire lifetime and currently smoking on average ≥1 cigarette per day), not intending to stop during the study

Who cannot join

  • Prior antibody or small molecule therapy against Epidermal growth factor receptor (EGFR)
  • Radiotherapy within 28 days prior to enrollment
  • Received more than one line of chemotherapy for locally advanced/metastatic NSCLC (first-line maintenance chemotherapy after first-line platinum-based chemotherapy is allowed)

Trial locations and contacts

63 sites in 9 countries.

63 sites in 9 countries

Germany15 sites

  • Study site

    Berlin, 13125

  • Study site

    Berlin, 14165

  • Study site

    Essen, 45122

  • Study site

    Gauting, 82131

  • Study site

    Großhansdorf, 22927

  • Study site

    Hanover, 30625

  • Study site

    Hanover, 30659

  • Study site

    Immenhausen, 34376

  • Study site

    Lostau, 39291

  • Study site

    München, 81925

  • Study site

    Nuremberg, 90419

  • Study site

    Rheine, 48431

  • Study site

    Villingen-Schwenningen, 78052

  • Study site

    Wuppertal, 42283

  • Study site

    Würselen, 52146

Other trials in Germany

China12 sites

  • Study site

    Beijing, 100071

  • Study site

    Changchun, 130012

  • Study site

    Chengdu, 610041

  • Study site

    Fuzhou, 350014

  • Study site

    Guangzhou, 510030

  • Study site

    Nanjing, 210009

  • Study site

    Nanning, 530021

  • Study site

    Shanghai, 200030

  • Study site

    Shanghai, 200433

  • Study site

    Shenyang, 110001

  • Study site

    Tianjin, 300060

  • Study site

    Wuhan, 430030

Other trials in China

Spain8 sites

  • Study site

    Barcelona, Barcelona, 08035

  • Study site

    Barcelona, Barcelona, 08041

  • Study site

    Madrid, Madrid, 28040

  • Study site

    Madrid, Madrid, 28041

  • Study site

    Málaga, Malaga, 29010

  • Study site

    Sabadell, Barcelona, Barcelona, 08208

  • Study site

    Seville, Sevilla, 41013

  • Study site

    Valencia, Valencia, 46009

Other trials in Spain

France7 sites

  • Study site

    Caen, 14076

  • Study site

    Limoges, 87042

  • Study site

    Marseille, 13915

  • Study site

    Paris, 75014

  • Study site

    Paris, 75674

  • Study site

    Paris, 75908

  • Study site

    Pontoise, 95300

Other trials in France

Turkey (Türkiye)7 sites

  • Study site

    Ankara, 06000

  • Study site

    Ankara, 06200

  • Study site

    Eskişehir, 26480

  • Study site

    Gaziantep, 27310

  • Study site

    Izmir, 35110

  • Study site

    Izmir, 35340

  • Study site

    Konya, 42050

Other trials in Turkey (Türkiye)

Denmark4 sites

  • Study site

    Copenhagen, 2100

  • Study site

    Hillerød, 3400

  • Study site

    Næstved, 4700

  • Study site

    Roskilde, 4000

Other trials in Denmark

Netherlands4 sites

  • Study site

    Amsterdam, 1007 MB

  • Study site

    Breda, 4818 CK

  • Study site

    Nieuwegein, 3435 CM

  • Study site

    Zwolle, 8011 JW

Other trials in Netherlands

Switzerland4 sites

  • Study site

    Baden, 5404

  • Study site

    Basel, 4031

  • Study site

    Bern, 3011

  • Study site

    Fribourg, 1708

Other trials in Switzerland

Egypt2 sites

  • Study site

    Cairo, 11796

  • Study site

    Cairo

Other trials in Egypt

About this study

Official title: A Prospective, Double-blind Randomized Phase III Study of 300 mg Versus 150 mg Erlotinib in Current Smokers With Locally Advanced or Metastatic NSCLC in Second-line Setting After Failure on Chemotherapy (CURRENTS)

This prospective, double-blind, randomized study will evaluate the safety and efficacy of two dose levels of erlotinib [Tarceva] on progression-free survival, response and disease control rates and overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must be current smokers and not intending to stop smoking during the study. Patients will be randomized to receive either 150 mg or 300 mg of study drug as single daily oral doses. Treatment will continue until disease progression.

Being tested
Erlotinib [Tarceva]
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • Erlotinib [Tarceva]Drug

    Also called Tarceva

    Single daily oral dose

Study groups in NCT01183858
Study groupRoleWhat they receive
Erlotinib 150 mgExperimentalErlotinib 150 mg single daily oral dose until disease progression.
Receives: Drug: Erlotinib [Tarceva]
Erlotinib 300 mgExperimentalErlotinib 300 mg single daily oral dose until disease progression.
Receives: Drug: Erlotinib [Tarceva]

What is being measured

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

  1. Progression-Free Survival (PFS)

    PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.

    Measured: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months)

  2. Progression-Free Survival (PFS) at the End of Study

    PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.

    Measured: Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)

Secondary outcomes (6)

  1. Overall Survival (OS)

    OS defined as the time from randomization to the date of death due to any cause.

    Measured: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)

  2. Overall Response Rate (ORR)

    Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A participant was defined as a responder if they sustained a complete response (CR) or partial response (PR) for at least 4 weeks during randomized treatment (confirmed response). Patients with no tumor assessment after the start of study treatment were to be considered as non-responders. The percentage of participants in each best response category is presented.

    Measured: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)

  3. Disease Control Rate (DCR)

    Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans. Disease control rates were measured according to RECIST version 1.1 criteria. A participant was defined as having controlled disease if they sustained a Complete Response (CR) or Partial Response (PR) for at least 4 weeks during randomized treatment (confirmed response), or Stable Disease (SD) for at least 6 weeks. Patients with no tumor assessment after the start of study treatment were considered as having uncontrolled disease. The percentage of participants with Disease Control is presented.

    Measured: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)

  4. Time to Progression (TTP)

    Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. Time to progression (TTP) in weeks was defined as the time from randomization to the date of disease progression. Participants without event were censored at the date of the last tumor assessment when the patient was known to be progression free.

    Measured: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)

  5. Number of Participants With Adverse Events (AEs) at the End of the Study

    An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.

    A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.

    Adverse Events in the following categories are presented: Adverse Events, Serious Adverse Events, AEs leading to withdrawal from treatment and AEs leading to death.

    Measured: Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)

  6. Overall Survival (OS) at the End of Study

    OS defined as the time from randomization to the date of death due to any cause.

    Measured: Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)

Timeline

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

  1. First posted18 Aug 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionOct 2013
  4. Study completionFeb 2014

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
Double blind
Who is masked
Participant, Investigator
Enrolment
315 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01183858
Sponsor's protocol ID
MO22162
Other IDs
2010-018476-24
Status last verified
Jul 2015
First submitted
16 Aug 2010
Last updated
19 Aug 2015

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Erlotinib [Tarceva] in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 63 sites in 9 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 7 inclusion and 3 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 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in Germany, China, Spain, France, Turkey (Türkiye) and 4 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?

Yes. Results are posted in the registry (first posted 23 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression-Free Survival (PFS) (time frame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months)). 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 NCT01183858.

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 19 Aug 2015.

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