NCT01085136|CompletedPhase 3Results

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

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)

Boehringer Ingelheim ClinicalTrials.gov

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2 other identifiers

1200.422009-014563-39

Study Type

interventional

Target

1,154

Locations

22 countries

Sites

Timeline

RegisteredMar 2010

StartedFeb 2010

CompletionJan 2016

Brief 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. 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,154

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Feb 2010

Longer than P75 for phase_3

Geographic Reach

22 countries

96 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.9 years study duration

Study Start

First participant enrolled

February 1, 2010

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2010

Completed

3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed

1 year until next milestone

Results Posted

Study results publicly available

October 3, 2014

Completed

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed

Last Updated

April 4, 2017

Status Verified

February 1, 2017

Enrollment Period

3.7 years

First QC Date

March 10, 2010

Results QC Date

October 1, 2014

Last Update Submit

February 15, 2017

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (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.
From randomization until disease progression or death; Up to 32 months

Secondary Outcomes (5)

Progression Free Survival (Part A)
From first dose administration until disease progression or death; Up to 51 months
Overall Survival (Part B)
From randomization until death; Up to 32 months
Objective Response (Part A)
Post baseline tumour-imaging was performed at every 6 weeks thereafter until disease progression; upto 51 months
Objective Response (Part B)
Post baseline tumour-imaging was performed at every 8 weeks thereafter until disease progression; up to 32 Months
Intensity and Incidence of Adverse Events (AEs) for Part A & Part B.
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)

Study Arms (2)

Investigator's choice of chemotherapy

ACTIVE COMPARATOR

Patients will be treated with investigator's choice of chemotherapy

Drug: Investigator´s choice of chemotherapy

BIBW 2992 and Paclitaxel

EXPERIMENTAL

Patients will be treated with BIBW 2992daily with a medium dose and weekly administration of Paclitaxel at a dose of 80 mg/m2

Drug: BIBW 2992

Interventions

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

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

BIBW 2992 and Paclitaxel

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.
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.
) 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

You may not qualify if:

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)
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
+8 more criteria

Contact the study team to confirm eligibility.