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 3

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Investigator´s choice of chemotherapy; Drug: BIBW 2992

• Registration Number: NCT01085136
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-10
• Study First Submitted QC: 2010-03-10
• Study First Posted: 2010-03-11
• Primary Completion: 2013-10
• Results First Submitted: 2014-10-01
• Results First Submitted QC: 2014-10-01
• Results First Posted: 2014-10-03
• Study Completion: 2016-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-15
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1154

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigator's choice of chemotherapy	Investigator´s choice of chemotherapy	Patients will be treated with investigator's choice of chemotherapy
BIBW 2992 and Paclitaxel	BIBW 2992	Patients will be treated with BIBW 2992daily with a medium dose and weekly administration of Paclitaxel at a dose of 80 mg/m2

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (Part B)	From randomization until disease progression or death; Up to 32 months	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.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (Part A)	From first dose administration until disease progression or death; Up to 51 months	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.
Overall Survival (Part B)	From randomization until death; Up to 32 months	Overall survival (OS) as determined by the time from randomization to death in part B.; Median was calculated from the Kaplan-Meier curve.
Objective Response (Part A)	Post baseline tumour-imaging was performed at every 6 weeks thereafter until disease progression; upto 51 months	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.
Objective Response (Part B)	Post baseline tumour-imaging was performed at every 8 weeks thereafter until disease progression; up to 32 Months	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 .
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)	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).

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇬🇧 Truro, Cornwall, United Kingdom