AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 3NCT01085136

LUX-Lung 5: Afatinib Plus Weekly Paclitaxel Versus Investigator's Choice of Single Agent Chemotherapy Following Afatinib Monotherapy in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib

A Phase 3 study testing Investigator´s choice of chemotherapy and BIBW 2992 in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 97 sites in 23 countries.

Completed

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

Official record
Search all trials

Trial summary

The primary objective of this randomized, open-label, active-controlled, multi-center trial is to determine the efficacy of BIBW 2992 given as an add-on to chemotherapy in patients with NSCLC Stage IIIb or IV progressing after BIBW 2992 monotherapy compared to chemotherapy alone in this patient population. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Investigator´s choice of chemotherapy and BIBW 2992
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,154 participants
Where
97 sitesin 23 countries
Study dates
Feb 2010to Jan 2016
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

  • Part A
  • Patients with pathologically confirmed diagnosis of NSCLC Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV who have failed treatment with erlotinib (Tarceva) or gefitinib (Iressa).
  • Patients should have received and failed at least one line of cytotoxic chemotherapy including a platinum-based regimen in patients eligible for platinum-based therapy and pemetrexed in pemetrexed eligible patients (unless pemetrexed is not considered a regulatory or clinical standard of care e.g. no label indication, no availability or no coverage by 3rd party payer(s)) for advanced or metastatic disease and have progressive disease following at least 12 weeks of treatment with erlotinib or gefitinib
  • Patients pretreated with taxane-based chemotherapy for advanced or metastatic disease must have experienced stable disease, partial or complete response as best response
  • Eastern Cooperative Oncology Group performance Score 0 or 1.
  • Patients with at least one tumor lesion that can accurately be measured by magnetic resonance imaging (MRI), or computed tomography (CT) in at least one dimension with longest diameter to be recorded as 10 mm but no less than double the slice thickness according to RESIST 1.1.
Show all 10Show fewer
  • Male and female patients no less than 18 years of age.
  • Life expectancy of at least three (3) months.
  • Written informed consent that is consistent with ICH-GCP guidelines. Part B 1) Clinical benefit (disease stabilization or antitumor response) of 12 weeks duration in Part A of the trial determined on the second tumour assessment.
  • 2.) Patients should have progressed in Part A according to RECIST 1.1 3.) New informed consent, including consent to biomarker sampling, must be signed before patients enter Part B of the trial

Who cannot join

  • Previous treatment with BIBW 2992
  • Chemo-, hormone- (other than megestrol acetate, steroids required for maintenance non-cancer therapy or as premedication before chemotherapy) or immunotherapy within the past 4 weeks; except for TKI pretreatment (2 weeks only)
  • Active/symptomatic brain metastases including leptomeningeal disease. Patients with a history of treated brain metastasis must have a stable or normal brain MRT/CT scan at screening and be at least 4 weeks post-radiation or surgery for brain metastasis. Dexamethasone therapy will be allowed if administered as a stable dose for at least one month before randomization.
  • Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g., Crohn's disease, mal-absorption, or CTCAE Grade >2 diarrhea of any etiology at baseline
  • Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the Investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug
  • Other malignancies diagnosed within the past five (5) years (other than non-melanomatous skin cancer and in situ cervical cancer)
Show all 23Show fewer
  • Radiotherapy within the past 2 weeks prior to treatment with the trial drug
  • History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New york Heart Association (NYHA) functional classification of 3, unstable angina, or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to entering the trial.
  • Cardiac left ventricular function with resting ejection fraction of less than 50% measured by multigated blood pool imaging of the heart (MUGA scan) or echocardiogram .
  • Prior treatment with anthracyclines with a cumulative dose of doxorubicin (or equivalent) at or greater than 400 mg/m2
  • Absolute neutrophil count (ANC) at or less than 1500 / mm3
  • Platelet count at or less than 100,000 / mm3
  • Bilirubin at or greater than 1.5 mg / dL (>26 mol / L, SI unit equivalent)
  • Aspartate amino transferase (AST) or alanine amino transferase (ALT) at or greater than three times the upper limit of normal (if related to liver metastases at or greater than five times the upper limit of normal)
  • Serum creatinine at or greater 1.5 times the upper normal limit or calculated/measured creatinine clearance at or less than 45 mL/min
  • Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial
  • Pregnancy or breast feeding
  • Patients unable to comply with the protocol
  • Patients with any serious active infection including known human immunodeficiency virus (HIV), active hepatitis B or active hepatitis C
  • Known or suspected active drug or alcohol abuse
  • Pre-existing or current Interstitial lung disease (ILD) 22.)
  • Peripheral polyneuropathy of > Grade 2
  • Requirement for treatment with any of the pohibited concomitant medication listed in section 4.2.2.1.

Trial locations and contacts

97 sites in 23 countries.

97 sites in 23 countries

Germany9 sites

  • Boehringer Ingelheim Investigational Site

    Berlin

  • Boehringer Ingelheim Investigational Site

    Essen

  • Boehringer Ingelheim Investigational Site

    Esslingen am Neckar

  • Boehringer Ingelheim Investigational Site

    Gauting

  • Boehringer Ingelheim Investigational Site

    Hamburg

  • Boehringer Ingelheim Investigational Site

    Hanover

  • Boehringer Ingelheim Investigational Site

    Heidelberg

  • Boehringer Ingelheim Investigational Site

    Mainz

  • Boehringer Ingelheim Investigational Site

    Münster

Other trials in Germany

China8 sites

  • Boehringer Ingelheim Investigational Site

    Beijing

  • Boehringer Ingelheim Investigational Site

    Changchun

  • Boehringer Ingelheim Investigational Site

    Chengdu

  • Boehringer Ingelheim Investigational Site

    Fuzhou

  • Boehringer Ingelheim Investigational Site

    Guangzhou

  • Boehringer Ingelheim Investigational Site

    Hangzhou

  • Boehringer Ingelheim Investigational Site

    Nanjing

  • Boehringer Ingelheim Investigational Site

    Shanghai

Other trials in China

France8 sites

  • Boehringer Ingelheim Investigational Site

    Bayonne

  • Boehringer Ingelheim Investigational Site

    Caen

  • Boehringer Ingelheim Investigational Site

    Dijon

  • Boehringer Ingelheim Investigational Site

    La Tronche

  • Boehringer Ingelheim Investigational Site

    Lyon

  • Boehringer Ingelheim Investigational Site

    Paris

  • Boehringer Ingelheim Investigational Site

    Saint-Herblain

  • Boehringer Ingelheim Investigational Site

    Villejuif

Other trials in France

Italy8 sites

  • Boehringer Ingelheim Investigational Site

    Avellino

  • Boehringer Ingelheim Investigational Site

    Aviano (PN)

  • Boehringer Ingelheim Investigational Site

    Bergamo

  • Boehringer Ingelheim Investigational Site

    Genova

  • Boehringer Ingelheim Investigational Site

    Milan

  • Boehringer Ingelheim Investigational Site

    Monza (mi)

  • Boehringer Ingelheim Investigational Site

    Ravenna

  • Boehringer Ingelheim Investigational Site

    Roma

Other trials in Italy

United Kingdom8 sites

  • Boehringer Ingelheim Investigational Site

    Brighton

  • Boehringer Ingelheim Investigational Site

    Dundee

  • Boehringer Ingelheim Investigational Site

    Exeter

  • Boehringer Ingelheim Investigational Site

    London

  • Boehringer Ingelheim Investigational Site

    Maidstone

  • Boehringer Ingelheim Investigational Site

    Manchester

  • Boehringer Ingelheim Investigational Site

    Sutton, Surrey

  • Boehringer Ingelheim Investigational Site

    Truro, Cornwall

Other trials in United Kingdom

Belgium7 sites

  • Boehringer Ingelheim Investigational Site

    Aalst

  • Boehringer Ingelheim Investigational Site

    Brussels

  • Boehringer Ingelheim Investigational Site

    Duffel

  • Boehringer Ingelheim Investigational Site

    La Louvière

  • Boehringer Ingelheim Investigational Site

    Liège

  • Boehringer Ingelheim Investigational Site

    Middelheim

  • Boehringer Ingelheim Investigational Site

    Ottignies

Other trials in Belgium

Spain6 sites

  • Boehringer Ingelheim Investigational Site

    A Coruña

  • Boehringer Ingelheim Investigational Site

    Barcelona

  • Boehringer Ingelheim Investigational Site

    Madrid

  • Boehringer Ingelheim Investigational Site

    Málaga

  • Boehringer Ingelheim Investigational Site

    Mataró

  • Boehringer Ingelheim Investigational Site

    Valencia

Other trials in Spain

Australia5 sites

  • Boehringer Ingelheim Investigational Site

    Box Hill, Victoria

  • Boehringer Ingelheim Investigational Site

    Fitzroy, Victoria

  • Boehringer Ingelheim Investigational Site

    Kingswood, New South Wales

  • Boehringer Ingelheim Investigational Site

    South Brisbane, Queensland

  • Boehringer Ingelheim Investigational Site

    Wodonga, Victoria

Other trials in Australia

India5 sites

  • Boehringer Ingelheim Investigational Site

    Chennai

  • Boehringer Ingelheim Investigational Site

    Jaipur

  • Boehringer Ingelheim Investigational Site

    Maharashtra

  • Boehringer Ingelheim Investigational Site

    Mumbai

  • Boehringer Ingelheim Investigational Site

    Nashik, Maharashtra

Other trials in India

Taiwan5 sites

  • Boehringer Ingelheim Investigational Site

    Kaohsiung City

  • Boehringer Ingelheim Investigational Site

    Taichung

  • Boehringer Ingelheim Investigational Site

    Tainan

  • Boehringer Ingelheim Investigational Site

    Taipei

  • Boehringer Ingelheim Investigational Site

    Taoyuan

Other trials in Taiwan

Poland4 sites

  • Boehringer Ingelheim Investigational Site

    Gdansk

  • Boehringer Ingelheim Investigational Site

    Olsztyn

  • Boehringer Ingelheim Investigational Site

    Otwock

  • Boehringer Ingelheim Investigational Site

    Warsaw

Other trials in Poland

Ukraine4 sites

  • Boehringer Ingelheim Investigational Site

    Dnipropetrovks

  • Boehringer Ingelheim Investigational Site

    Donetsk

  • Boehringer Ingelheim Investigational Site

    Kharkiv

  • Boehringer Ingelheim Investigational Site

    Kyiv

Other trials in Ukraine

Hungary3 sites

  • Boehringer Ingelheim Investigational Site

    Budapest

  • Boehringer Ingelheim Investigational Site

    Pécs

  • Boehringer Ingelheim Investigational Site

    Törökbálint

Other trials in Hungary

Israel3 sites

  • Boehringer Ingelheim Investigational Site

    Kfar Saba

  • Boehringer Ingelheim Investigational Site

    Petah Tikva

  • Boehringer Ingelheim Investigational Site

    Tel HaShomer

Other trials in Israel

South Korea3 sites

  • Boehringer Ingelheim Investigational Site

    Goyang

  • Boehringer Ingelheim Investigational Site

    Hwasun

  • Boehringer Ingelheim Investigational Site

    Seoul

Other trials in South Korea

Netherlands2 sites

  • Boehringer Ingelheim Investigational Site

    Maastricht

  • Boehringer Ingelheim Investigational Site

    Nieuwegein

Other trials in Netherlands

Peru2 sites

  • Boehringer Ingelheim Investigational Site

    Arequipa

  • Boehringer Ingelheim Investigational Site

    La Victoria

Other trials in Peru

Russia2 sites

  • Boehringer Ingelheim Investigational Site

    Obninsk

  • Boehringer Ingelheim Investigational Site

    Saint Petersburg

Other trials in Russia

Argentina1 site

  • Boehringer Ingelheim Investigational Site

    Buenos Aires

Other trials in Argentina

Austria1 site

  • Boehringer Ingelheim Investigational Site

    Salzburg

Other trials in Austria

Brazil1 site

  • Boehringer Ingelheim Investigational Site

    Porto Alegre

Other trials in Brazil

Finland1 site

  • Boehringer Ingelheim Investigational Site

    Helsinki

Other trials in Finland

Mexico1 site

  • Boehringer Ingelheim Investigational Site

    Distrito Federal

Other trials in Mexico

About this study

Official title: Phase III Randomized Trial of BIBW 2992 Plus Weekly Paclitaxel Versus Investigator's Choice of Chemotherapy Following BIBW 2992 Monotherapy in Non-small Cell Lung Cancer Patients Failing Previous Erlotinib or Gefitinib Treatment (LUX Lung 5)

The primary objective of this randomized, open-label, active-controlled, multi-center trial is to determine the efficacy of BIBW 2992 given as an add-on to chemotherapy in patients with NSCLC Stage IIIb or IV progressing after BIBW 2992 monotherapy compared to chemotherapy alone in this patient population. Patients on both treatment arms will receive best supportive care in addition to study treatment. Patients enrolled into the trial will be treated and followed until death or lost to follow-up. Additional information on the health-related quality of life (HRQOL) will be collected.

Being tested
Investigator´s choice of chemotherapy, BIBW 2992
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.

  • Investigator´s choice of chemotherapyDrug

    BIBW 2992 in a medium dose in combination with Paclitaxel to explore safety and efficacy versus investigator´s choice of chemotherapy

  • BIBW 2992Drug

    BIBW 2992 will be given in a medium dose in combination with Paclitaxel to explore safety and efficacy versus investigator´s choice of chemotherapy

Study groups in NCT01085136
Study groupRoleWhat they receive
Investigator's choice of chemotherapyActive comparatorPatients will be treated with investigator's choice of chemotherapy
Receives: Drug: Investigator´s choice of chemotherapy
BIBW 2992 and PaclitaxelExperimentalPatients will be treated with BIBW 2992daily with a medium dose and weekly administration of Paclitaxel at a dose of 80 mg/m2
Receives: Drug: BIBW 2992

What is being measured

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

  1. Progression Free Survival (Part B)

    Progression free survival (PFS) time as determined by Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 from day of randomization until disease progression or death for patients randomised to combination therapy with afatinib plus paclitaxel or to investigator's choice of chemotherapy.

    Median was calculated from the Kaplan-Meier curve.

    Measured: From randomization until disease progression or death; Up to 32 months

Secondary outcomes (5)

  1. Progression Free Survival (Part A)

    Progression free survival (PFS) as determined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 for Part A.

    Median was calculated from the Kaplan-Meier curve.

    Measured: From first dose administration until disease progression or death; Up to 51 months

  2. Overall Survival (Part B)

    Overall survival (OS) as determined by the time from randomization to death in part B.

    Median was calculated from the Kaplan-Meier curve.

    Measured: From randomization until death; Up to 32 months

  3. Objective Response (Part A)

    Objective response defined as the best overall response of complete response [CR]: disappearance of all target lesion \& partial response [PR]: ≥30% decrease in the sum of the longest diameter of target lesions , taking as reference the baseline sum longest diameter of Afatinib monotherapy according to RECIST 1.1 for Part A.

    Measured: Post baseline tumour-imaging was performed at every 6 weeks thereafter until disease progression; upto 51 months

  4. Objective Response (Part B)

    Objective response (CR, PR) of Afatinib/paclitaxel combination therapy and comparator chemotherapy in Part B after progression in Part A according to RECIST 1.1 .

    Measured: Post baseline tumour-imaging was performed at every 8 weeks thereafter until disease progression; up to 32 Months

  5. Intensity and Incidence of Adverse Events (AEs) for Part A & Part B.

    Safety of Afatinib as indicated by intensity and incidence of adverse events, graded according to United States National Cancer Institute Common terminology Criteria for Adverse Events (US NCI CTCAE) Version 3.0 both for Part A and Part B. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).

    Measured: From first administration of treatment until 28 days after last drug administration, up to 51 Months (Part A) and from randomization until 28 days after last drug administration of Trial medication, up to 32 Months (Part B)

Timeline

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

  1. First posted11 Mar 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionOct 2013
  4. Study completionJan 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
1,154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01085136
Sponsor's protocol ID
1200.42
Other IDs
2009-014563-39, 2009
Status last verified
Feb 2017
First submitted
10 Mar 2010
Last updated
4 Apr 2017

Publications

  • Schuler M, Yang JC, Park K, Kim JH, Bennouna J, Chen YM, Chouaid C, De Marinis F, Feng JF, Grossi F, Kim DW, Liu X, Lu S, Strausz J, Vinnyk Y, Wiewrodt R, Zhou C, Wang B, Chand VK, Planchard D; LUX-Lung 5 Investigators. Afatinib beyond progression in patients with non-small-cell lung cancer following chemotherapy, erlotinib/gefitinib and afatinib: phase III randomized LUX-Lung 5 trial. Ann Oncol. 2016 Mar;27(3):417-23. doi: 10.1093/annonc/mdv597. Epub 2015 Dec 8.

    PubMed 26646759

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Investigator´s choice of chemotherapy and BIBW 2992 in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 97 sites in 23 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 10 inclusion and 23 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 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in Germany, China, France, Italy, United Kingdom and 18 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 3 Oct 2014). 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 (Part B) (time frame: From randomization until disease progression or death; Up to 32 months). 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 NCT01085136, which also lists 1 linked publication.

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 4 Apr 2017.

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