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

NCT ID: NCT01466660

Last Updated: 2020-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 319 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-13
• Study Completion Date: 2019-04-12

Brief 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.

Conditions

Lung Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

afatinib

afatinib once daily.

Group Type: EXPERIMENTAL

Afatinib

Intervention Type: DRUG

afatinib once daily

gefitinib

gefitinib once daily

Group Type: ACTIVE_COMPARATOR

gefitinib

Intervention Type: DRUG

Gefitinib once daily

Interventions

Afatinib

afatinib once daily

Intervention Type: DRUG

gefitinib

Gefitinib once daily

Intervention Type: DRUG

Other Intervention Names

Giotrif® / Gilotrif®

Eligibility Criteria

Inclusion Criteria

1. Pathologically confirmed diagnosis of Stage IIIB / IV adenocarcinoma of the lung.

2. Documented activating epidermal growth factor receptor mutation (Del19 and/or L858R) with tumour tissues.

3. At least one measurable lesion according to response evaluation criteria in solid tumours version 1.1

4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

5. Age >= 18 years.

6. Adequate organ function as defined by the following criteria:

Serum aspartate transaminase(AST) and serum alanine transaminase(ALT) =< 3 x upper limit of normal (ULN), or AST and ALT =<5 x ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin =<1.5 x ULN Absolute neutrophil count (ANC) >=1.5 x 109/L Creatinine clearance > 45ml / min Platelets >= 75 x 109/L

Exclusion Criteria

1. 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.

2. Prior treatment with epidermal growth factor receptor targeting small molecules or antibodies.

3. Major surgery within 4 weeks of study randomisation.

4. Active brain metastases

5. Meningeal carcinomatosis.

6. 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.

7. Known pre-existing interstitial lung disease.

8. Clinically relevant cardiovascular abnormalities as judged by the investigator.

9. Cardiac left ventricular function with resting ejection fraction of less than institutional lower limit of normal.

10. 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.

11. Pregnancy or breast-feeding.

12. Active hepatitis and/or known HIV carrier

13. Any prohibited concomitant medications for therapy with afatinib or gefitinib

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Chris Obrien Lifehouse

Camperdown, New South Wales, Australia

St George Hospital

Kogarah, New South Wales, Australia

The Prince Charles Hospital

Chermside, Queensland, Australia

Haematology & Oncology Clinics of Australasia (HOCA)

South Brisbane, Queensland, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Cross Cancer Institute (University of Alberta)

Edmonton, Alberta, Canada

British Columbia Cancer Agency (BCCA) - Fraser Valley Cancer

Surrey, British Columbia, Canada

BC Cancer Agency - Vancouver

Vancouver, British Columbia, Canada

Lakeridge Health Oshawa

Oshawa, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Montreal General Hospital - McGill University Health Centre

Montreal, Quebec, Canada

Cancer Hospital of Chinese Academy of Medical Science

Beijing, , China

Beijing Cancer Hospital

Beijing, , China

Sun Yat-Sen University Cancer Center

Guangzhou, , China

The Affiliated Cancer Hospital, Guangxi Medical University

Nanning, , China

Shanghai Chest Hospital

Shanghai, , China

Zhongshan Hospital Fudan University

Shanghai, , China

The First Hospital of Chinese Medical University

Shenyang, , China

CTR Oncologie du Pays Basque, Onco, Bayonne

Bayonne, , France

CTR François Baclesse

Caen, , France

HOP Intercommunal

Créteil, , France

HOP Michallon

La Tronche, , France

HOP Dupuytren 1

Limoges, , France

CTR Leon Berard

Lyon, , France

CTR René Gauducheau

Saint-Herblain, , France

HOP Sud-Réunion, Pneumo, Saint Pierre

St-Pierre - La Réunion, , France

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, , Germany

Klinikum Esslingen GmbH

Esslingen am Neckar, , Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, , Germany

Queen Mary Hospital

Hong Kong, , Hong Kong

Prince of Wales Hospital

Shatin, , Hong Kong

St James's Hospital

Dublin, , Ireland

Beaumont Hospital

Dublin, , Ireland

Oslo Universitetssykehus HF, Radiumhospitalet

Oslo, , Norway

National Cancer Centre

Singapore, , Singapore

Johns Hopkins Singapore International Medical Center

Singapore, , Singapore

Chungbuk National University Hospital

Cheongju-si, , South Korea

Gachon University Gil Medical Center

Incheon, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Regional Universitario de Málaga

Málaga, , Spain

Hospital Central de Asturias

Oviedo, , Spain

Hospital Universitario Marqués de Valdecilla

Santander, , Spain

Hospital Virgen del Rocío

Seville, , Spain

Sahlgrenska US, Göteborg

Gothenburg, , Sweden

Universitetssjukhuset, Linköping

Linköping, , Sweden

Skånes universitetssjukhus, Lund

Lund, , Sweden

Karolinska Univ. sjukhuset

Stockholm, , Sweden

Taichung Veterans General Hospital

Taichung, , Taiwan

NCKUH

Tainan City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipe Veterans General Hospital

Taipei, , Taiwan

Chang Gung Memorial Hospital(Linkou)

Taoyuan District, , Taiwan

Aberdeen Royal Infirmary

Aberdeen, , United Kingdom

Birmingham City Hospital

Birmingham, , United Kingdom

Velindre Cancer Centre

Cardiff, , United Kingdom

Western General Hospital

Edinburgh, , United Kingdom

Royal Surrey County Hospital

Guildford, , United Kingdom

Countries

Australia; Canada; China; France; Germany; Hong Kong; Ireland; Norway; Singapore; South Korea; Spain; Sweden; Taiwan; United Kingdom

References

Wu YL, Sequist LV, Tan EH, Geater SL, Orlov S, Zhang L, Lee KH, Tsai CM, Kato T, Barrios CH, Schuler M, Hirsh V, Yamamoto N, O'Byrne K, Boyer M, Mok T, Peil B, Marten A, Chih-Hsin Yang J, Paz-Ares L, Park K. Afatinib as First-line Treatment of Older Patients With EGFR Mutation-Positive Non-Small-Cell Lung Cancer: Subgroup Analyses of the LUX-Lung 3, LUX-Lung 6, and LUX-Lung 7 Trials. Clin Lung Cancer. 2018 Jul;19(4):e465-e479. doi: 10.1016/j.cllc.2018.03.009. Epub 2018 Mar 17.

Reference Type: DERIVED

PMID: 29653820 (View on PubMed)

Paz-Ares L, Tan EH, O'Byrne K, Zhang L, Hirsh V, Boyer M, Yang JC, Mok T, Lee KH, Lu S, Shi Y, Lee DH, Laskin J, Kim DW, Laurie SA, Kolbeck K, Fan J, Dodd N, Marten A, Park K. Afatinib versus gefitinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: overall survival data from the phase IIb LUX-Lung 7 trial. Ann Oncol. 2017 Feb 1;28(2):270-277. doi: 10.1093/annonc/mdw611.

Reference Type: DERIVED

PMID: 28426106 (View on PubMed)

Park K, Tan EH, O'Byrne K, Zhang L, Boyer M, Mok T, Hirsh V, Yang JC, Lee KH, Lu S, Shi Y, Kim SW, Laskin J, Kim DW, Arvis CD, Kolbeck K, Laurie SA, Tsai CM, Shahidi M, Kim M, Massey D, Zazulina V, Paz-Ares L. Afatinib versus gefitinib as first-line treatment of patients with EGFR mutation-positive non-small-cell lung cancer (LUX-Lung 7): a phase 2B, open-label, randomised controlled trial. Lancet Oncol. 2016 May;17(5):577-89. doi: 10.1016/S1470-2045(16)30033-X. Epub 2016 Apr 12.

Reference Type: DERIVED

PMID: 27083334 (View on PubMed)

Other Identifiers

2011-001814-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1200.123

Identifier Type: -

Identifier Source: org_study_id