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LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy | Clinical Trials | Clareo Health

COMPLETEDPHASE3

LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy

LUX-Lung 8: A Randomized, Open-label Phase III Trial of Afatinib Versus Erlotinib in Patients With Advanced Squamous Cell Carcinoma of the Lung as Second-line Therapy Following First-line Platinum-based Chemotherapy

NCT01523587•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

This randomised, open-label phase III trial will be performed in patients with advanced squamous cell carcinoma of the lung requiring second-line treatment after receiving first-line platinum-based chemotherapy. The primary objective of this trial is to compare the efficacy of BIBW 2992 to erlotinib as second-line treatment in this group of patients.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosis of advanced stage NSCLC squamous histology.
•2. Platinum-based doublet chemotherapy as 1st line treatment of Stage IIIB/IV NSCLC.
•3. Eligible to receive 2nd line therapy in the opinion of the investigator.
•4. Measurable disease according to RECIST 1.1.
•5. Adequate Performance Status.
•6. Availability of tumour tissue material for correlative studies. Archived tumour tissue is acceptable.
•7. Adequate organ function.
•8. Age = 18 years and above.
•9. Written informed consent that is consistent with International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP) guidelines.

Exclusion Criteria

•1. Prior treatment with Epidermal Growth Factor Receptor (EGFR) directed small molecules or antibodies.
•2. Radiotherapy within 4 weeks prior to randomization.
•3. Active brain metastases .
•4. Any other current malignancy or malignancy diagnosed within the past three (3) years (other than basal-cell carcinoma of the skin, in situ cervical cancer, in situ prostate cancer).
•5. Known pre-existing interstitial lung disease.
•6. Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom
•7. Any other concomitant serious 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.
•8. Women of child-bearing potential 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.
•9. Female patients of childbearing potential (see Section 4.2.3.3) who:
•1. are nursing or
+10 more criteria

Locations (192)

Ironwood Cancer and Research Centers

Chandler, Arizona, United States

University of California

La Jolla, California, United States

Sutter Medical Group

Sacramento, California, United States

Boca Raton Reginl Hospital-Lynn Cancer Institute

Boca Raton, Florida, United States

Memorial Healthcare System

Hollywood, Florida, United States

Cancer Care of North Florida, PA

Lake City, Florida, United States

Illinois Cancer Specialists

Niles, Illinois, United States

Orchard Healthcare Research Inc

Skokie, Illinois, United States

University of Louisville

Louisville, Kentucky, United States

West Jefferson General Hospital and Cancer Clinic

Marrero, Louisiana, United States

Key Dates

Start Date

March 5, 2012

Primary Completion Date

October 21, 2013

Completion Date

December 27, 2017

Last Updated

February 15, 2019

Enrollment

795

ACTUAL participants

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

afatinib

DRUG

erlotinib

DRUG

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

NCT04165798

Carcinoma, Non-Small-Cell Lung

View study

RECRUITINGPHASE2

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

NCT06667908

Carcinoma, Non-Small-Cell Lung

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy

Inclusion Criteria

Exclusion Criteria

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

A Study of LY4175408 in Participants With Advanced Cancer

A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)