Phase 2
N=319
LUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line EGFR Mutation Positive Adenocarcinoma of the Lung
Lung Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT01466660 ↗Enrolled (actual)
319
Serious AEs
43.6%
Results posted
Jun 2017
Primary outcome: Primary: Progression-free Survival — 12.78; 11.17 Months — p=0.0891
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Afatinib (Drug); gefitinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
12.78; 11.17 | 0.0891 |
| PRIMARY Time to Treatment Failure (TTF) (Main Overall Survival Analysis Cut-off Date, 08 April 2016) |
13.67; 11.53 | 0.0136 sig |
| PRIMARY Overall Survival |
27.86; 24.54 | 0.2343 |
| SECONDARY Objective Response Rate |
79.4; 74.8 | 0.3235 |
| SECONDARY Time to Objective Response |
81; 74; 112; 107; 119; 117 | — |
| SECONDARY Duration of Objective Response |
11.86; 11.07 | — |
| SECONDARY Disease Control |
94.4; 93.7 | 0.7856 |
| SECONDARY Duration of Disease Control |
12.88; 11.73 | — |
| SECONDARY Tumour Shrinkage (Main Overall Survival Analysis Cut-off Date, 08 April 2016) |
34.79; 38.25 | 0.0657 |
| SECONDARY Health-related Quality of Life (Primary Analysis Cut-off Date, 21 August 2015) |
0.77; 0.80; 0.74; 0.77; 74.5; 76.0 | 0.1422 |
Summary
This is a randomised, open-label, phase IIb trial of afatinib to compare to gefitinib in first-line treatment setting with patients who are having epidermal growth factor receptor mutation positive advanced adenocarcinoma of the lung.
Eligibility Criteria
Inclusion criteria
- Pathologically confirmed diagnosis of Stage IIIB / IV adenocarcinoma of the lung.
- Documented activating epidermal growth factor receptor mutation (Del19 and/or L858R) with tumour tissues.
- At least one measurable lesion according to response evaluation criteria in solid tumours version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Age >= 18 years.
- Adequate organ function as defined by the following criteria:
Serum aspartate transaminase(AST) and serum alanine transaminase(ALT) = =1.5 x 109/L Creatinine clearance > 45ml / min Platelets >= 75 x 109/L
Exclusion criteria
- Prior systemic chemotherapy for stage IIIB or IV non-small cell lung cancer. Neo-/adjuvant chemotherapy, chemoradiation or radiotherapy is permitted if at least 12 months has elapsed prior to disease progression.
- Prior treatment with epidermal growth factor receptor targeting small molecules or antibodies.
- Major surgery within 4 weeks of study randomisation.
- Active brain metastases
- Meningeal carcinomatosis.
- Previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured in the opinion of investigator.
- Known pre-existing interstitial lung disease.
- Clinically relevant cardiovascular abnormalities as judged by the investigator.
- Cardiac left ventricular function with resting ejection fraction of less than institutional lower limit of normal.
- Women of child-bearing potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to study entry, for the duration of study participation and for at least 2 months after treatment has ended.
- Pregnancy or breast-feeding.
- Active hepatitis and/or known HIV carrier
- Any prohibited concomitant medications for therapy with afatinib or gefitinib
Data sourced from ClinicalTrials.gov (NCT01466660). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.