Carcinoma, Non-Small-Cell LungPhase 3NCT00656136

BIBW 2992 and BSC Versus Placebo and BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)

A Phase 3 study testing BIBW 2992 in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 90 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This randomized, double-blind, multi-center Phase IIb/III trial will be performed in patients with NSCLC who have received previous treatment with at least one but not more than two lines of cytotoxic chemotherapy (one line must have been a platinum-containing regimen) and either gefitinib or erlotinib for a period of… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoma, Non-Small-Cell Lung
What is being tested?: BIBW 2992
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 585 participants
Where: 90 sitesin 15 countries
Study dates: Apr 2008to Oct 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with pathologic confirmation of NSCLC Stage III-B (with pleural effusion) or Stage IV adenocarcinoma who have failed at least one but not more than two lines of cytotoxic chemotherapy (including adjuvant chemotherapy). One of the chemotherapy regimens must have been platinum-based.
Progressive disease following at least 12 weeks of treatment with erlotinib (Tarceva®) or gefitinib (Iressa®)
Eastern Cooperative Oncology Group (ECOG, R01-0787) performance Score 0, 1 or 2
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 >20 mm using conventional techniques or >10 mm with spiral CT scan
Male and female patients age >18 years
Life expectancy of at least three (3) months
Written informed consent that is consistent with ICH-GCP guidelines

Who cannot join

Use of erlotinib (Tarceva®) or gefitinib (Iressa®) within 14 days of treatment Day 1
Chemo-, hormone- (other than megestrol acetate or steroids required for maintenance non-cancer therapy) or immunotherapy within the past 4 weeks
Active brain metastases
Significant or recent acute gastrointestinal disorders with diarrhea
Patients who have any other life-threatening illness or organ system dysfunction,
Other malignancies diagnosed within the past five (5) years

Show all 11Show fewer

Radiotherapy within the past 2 weeks prior to treatment
History of clinically significant or uncontrolled cardiac disease
Adequate ANC and platelet count
Adequate liver and kidney function
Patients with any serious active infection including known HIV, active hepatitis B or active hepatitis C

Trial locations and contacts

90 sites in 15 countries.

Country

City, postcode or hospital

90 sites in 15 countries

United States14 sites

1200.23.027 Boehringer Ingelheim Investigational Site
Anaheim, California
1200.23.028 Boehringer Ingelheim Investigational Site
Berkeley, California
1200.23.046 Boehringer Ingelheim Investigational Site
Fayetteville, Arkansas
1200.23.038 Boehringer Ingelheim Investigational Site
Kingman, Arizona
1200.23.029 Boehringer Ingelheim Investigational Site
Modesto, California
1200.23.045 Boehringer Ingelheim Investigational Site
Montebello, California
1200.23.020 Boehringer Ingelheim Investigational Site
New York, New York
1200.23.024 Boehringer Ingelheim Investigational Site
North Miami Beach, Florida
1200.23.009 Boehringer Ingelheim Investigational Site
Orange, California
1200.23.026 Boehringer Ingelheim Investigational Site
Palm Springs, California
1200.23.039 Boehringer Ingelheim Investigational Site
Renton, Washington
1200.23.056 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
1200.23.050 Boehringer Ingelheim Investigational Site
Seattle, Washington
1200.23.013 Boehringer Ingelheim Investigational Site
Valhalla, New York

Other trials in United States

France11 sites

1200.23.3303A Boehringer Ingelheim Investigational Site
Besançon
1200.23.3303C Boehringer Ingelheim Investigational Site
Besançon
1200.23.3305A Boehringer Ingelheim Investigational Site
Caen
1200.23.3304A Boehringer Ingelheim Investigational Site
La Tronche
1200.23.3304B Boehringer Ingelheim Investigational Site
La Tronche
1200.23.3307A Boehringer Ingelheim Investigational Site
Lyon
1200.23.3301A Boehringer Ingelheim Investigational Site
Paris
1200.23.3302A Boehringer Ingelheim Investigational Site
Paris
1200.23.3302B Boehringer Ingelheim Investigational Site
Paris
1200.23.3306A Boehringer Ingelheim Investigational Site
Toulouse
1200.23.3306C Boehringer Ingelheim Investigational Site
Toulouse

Other trials in France

China9 sites

1200.23.86001 Boehringer Ingelheim Investigational Site
Beijing
1200.23.86002 Boehringer Ingelheim Investigational Site
Beijing
1200.23.86003 Boehringer Ingelheim Investigational Site
Beijing
1200.23.86009 Boehringer Ingelheim Investigational Site
Chengdu
1200.23.86007 Boehringer Ingelheim Investigational Site
Guangzhou
1200.23.86008 Boehringer Ingelheim Investigational Site
Hangzhou
1200.23.86004 Boehringer Ingelheim Investigational Site
Shanghai
1200.23.86005 Boehringer Ingelheim Investigational Site
Shanghai
1200.23.86006 Boehringer Ingelheim Investigational Site
Shanghai

Other trials in China

Germany8 sites

1200.23.49010 Zentralklinik Bad Berka GmbH
Bad Berka
1200.23.49002 Innere Klinik und Poliklinik (Tumorforschung)
Essen
1200.23.49003 Asklepios Fachkliniken München-Gauting
Gauting
1200.23.49005 Krankenhaus Großhansdorf
Großhansdorf
1200.23.49008 Universitätsklinik Hamburg-Eppendorf
Hamburg
1200.23.49004 Johannes Gutenberg-Universität Mainz
Mainz
1200.23.49001 Universitätsklinikum Mannheim
Mannheim
1200.23.49006 HSK, Dr. Horst-Schmidt-Kliniken GmbH
Wiesbaden

Other trials in Germany

Taiwan7 sites

1200.23.88604 Taichung Veterans General Hospital
Taichung
1200.23.88605 China Medical University Hospital
Taichung
1200.23.88606 National Cheng Kung University Hospital
Tainan
1200.23.88601 National Taiwan University Hospital
Taipei
1200.23.88602 Veterans General Hospital
Taipei
1200.23.88607 Tri-Service General Hospital
Taipei
1200.23.88603 Chang Gung Memorial Hosp-Linkou
Taoyuan

Other trials in Taiwan

Italy6 sites

1200.23.39003 Boehringer Ingelheim Investigational Site
Genova
1200.23.39007 Boehringer Ingelheim Investigational Site
Orbassano (TO)
1200.23.39002 Boehringer Ingelheim Investigational Site
Perugia
1200.23.39004 Boehringer Ingelheim Investigational Site
Prato
1200.23.39008 Boehringer Ingelheim Investigational Site
Roma
1200.23.39001 Boehringer Ingelheim Investigational Site
Rozzano (MI)

Other trials in Italy

South Korea6 sites

1200.23.82005 Boehringer Ingelheim Investigational Site
Gyeonggi-do
1200.23.82006 Boehringer Ingelheim Investigational Site
Hwasun
1200.23.82001 Boehringer Ingelheim Investigational Site
Seoul
1200.23.82002 Boehringer Ingelheim Investigational Site
Seoul
1200.23.82003 Boehringer Ingelheim Investigational Site
Seoul
1200.23.82004 Boehringer Ingelheim Investigational Site
Seoul

Other trials in South Korea

Spain6 sites

1200.23.3405 Boehringer Ingelheim Investigational Site
Barcelona
1200.23.3404 Boehringer Ingelheim Investigational Site
Cruces
1200.23.3401 Boehringer Ingelheim Investigational Site
Madrid
1200.23.3403 Boehringer Ingelheim Investigational Site
Madrid
1200.23.3406 Boehringer Ingelheim Investigational Site
Madrid
1200.23.3402 Boehringer Ingelheim Investigational Site
Valencia

Other trials in Spain

Belgium5 sites

1200.23.32004 Boehringer Ingelheim Investigational Site
Edegem
1200.23.32003 Boehringer Ingelheim Investigational Site
Ghent
1200.23.32001 Boehringer Ingelheim Investigational Site
Leuven
1200.23.32005 Boehringer Ingelheim Investigational Site
Liège
1200.23.32006 Boehringer Ingelheim Investigational Site
Namur

Other trials in Belgium

Canada5 sites

1200.23.1002 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
1200.23.1001 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1200.23.1004 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1200.23.1009 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1200.23.1005 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia

Other trials in Canada

United Kingdom5 sites

1200.23.4404 Boehringer Ingelheim Investigational Site
Dundee
1200.23.4403 Boehringer Ingelheim Investigational Site
Edinburgh
1200.23.4401 Boehringer Ingelheim Investigational Site
Glasgow
1200.23.4405 Boehringer Ingelheim Investigational Site
London
1200.23.4406 Boehringer Ingelheim Investigational Site
Sutton

Other trials in United Kingdom

Netherlands3 sites

1200.23.31002 Boehringer Ingelheim Investigational Site
Amsterdam
1200.23.31001 Boehringer Ingelheim Investigational Site
Groningen
1200.23.31003 Boehringer Ingelheim Investigational Site
Helmond

Other trials in Netherlands

Thailand3 sites

1200.23.66001 Boehringer Ingelheim Investigational Site
Chiang Mai
1200.23.66003 Boehringer Ingelheim Investigational Site
Pathumwan, Bangkok
1200.23.66002 Boehringer Ingelheim Investigational Site
Songkhla

Other trials in Thailand

Hong Kong1 site

1200.23.85202 Boehringer Ingelheim Investigational Site
Hong Kong

Other trials in Hong Kong

Singapore1 site

1200.23.65001 Boehringer Ingelheim Investigational Site
Singapore

Other trials in Singapore

About this study

Official title: Phase IIb/III Randomized, Double-blind Trial of BIBW 2992 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-Lung 1)

The primary objective of this randomized trial is to determine the efficacy of BIBW 2992 as a single agent (Arm A) as compared to a matching placebo (Arm B) 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.

Conditions: Carcinoma, Non-Small-Cell Lung
Being tested: placebo, BIBW 2992
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

placeboDrug
Patients receive placebo once daily
BIBW 2992Drug
Patients receive afatinib tablets once daily, and can reduce dose for adverse event management. Afatinib is given once daily, continuously until disease progression or unacceptable toxicity.

Study groups in NCT00656136
Study group	Role	What they receive
Placebo	Placebo comparator	Patients receive placebo once daily Receives: Drug: placebo
BIBW 2992	Experimental	Patients receive BIBW 2992 tablets once daily Receives: Drug: BIBW 2992

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival
Overall survival was the duration from the date of randomization to the date of death. Patients who were alive were censored at the last contact date prior to the database lock.
For the primary analysis 11 patients were lost to follow-up and were censored at the last contact date when they were known to be still alive. Primary analysis data cut-off date was 08 July 2010.
For the final analysis 13 patients were lost to follow-up and were censored at the last contact date when they were known to be still alive. Final analysis data cut-off date was 04 October 2013.
Measured: From randomization until death or the last patient out date, an average of 12 months

Secondary outcomes (2)

Progression-free Survival (PFS)
PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST 1.0).
Measured: From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months
Objective Response Rate (OR)
OR is defined as complete response (CR) and partial response (PR). Assessed by central independent review according to RECIST 1.0.
Measured: From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Oct 2013

First posted10 Apr 2008 (estimated)
Study startApr 2008
Primary completionOct 2013
Study completionOct 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 585 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00656136
Sponsor's protocol ID: 1200.23
Other IDs: 2007-005983-28
Status last verified: Jun 2016
First submitted: 4 Apr 2008
Last updated: 26 Jul 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Miller VA, Hirsh V, Cadranel J, Chen YM, Park K, Kim SW, Zhou C, Su WC, Wang M, Sun Y, Heo DS, Crino L, Tan EH, Chao TY, Shahidi M, Cong XJ, Lorence RM, Yang JC. Afatinib versus placebo for patients with advanced, metastatic non-small-cell lung cancer after failure of erlotinib, gefitinib, or both, and one or two lines of chemotherapy (LUX-Lung 1): a phase 2b/3 randomised trial. Lancet Oncol. 2012 May;13(5):528-38. doi: 10.1016/S1470-2045(12)70087-6. Epub 2012 Mar 26.
PubMed 22452896

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

All Carcinoma, Non-Small-Cell Lung trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase IIb/III Randomized, Double-blind Trial of BIBW 2992 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-Lung 1)
ClinicalTrials.gov ID: NCT00656136
Acronym / sponsor ID: 1200.23
Conditions: Carcinoma, Non-Small-Cell Lung
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 585 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 10 Apr 2008 (estimated)
Results: Posted 27 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Patients enrolled into the trial will be treated and followed until death or lost to follow-up.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: placeboPatients receive placebo once daily
BIBW 2992	Experimental	Drug: BIBW 2992Patients receive BIBW 2992 tablets once daily

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Patients with pathologic confirmation of NSCLC Stage III-B (with pleural effusion) or Stage IV adenocarcinoma who have failed at least one but not more than two lines of cytotoxic chemotherapy (including adjuvant chemotherapy). One of the chemotherapy regimens must have been platinum-based.
Progressive disease following at least 12 weeks of treatment with erlotinib (Tarceva®) or gefitinib (Iressa®)
Eastern Cooperative Oncology Group (ECOG, R01-0787) performance Score 0, 1 or 2
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 >20 mm using conventional techniques or >10 mm with spiral CT scan
Male and female patients age >18 years

Key exclusion criteria (11 listed)

Use of erlotinib (Tarceva®) or gefitinib (Iressa®) within 14 days of treatment Day 1
Chemo-, hormone- (other than megestrol acetate or steroids required for maintenance non-cancer therapy) or immunotherapy within the past 4 weeks
Active brain metastases
Significant or recent acute gastrointestinal disorders with diarrhea
Patients who have any other life-threatening illness or organ system dysfunction,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
placeboPatients receive placebo once daily	Drug	Placebo
BIBW 2992Patients receive afatinib tablets once daily, and can reduce dose for adverse event management. Afatinib is given once daily, continuously until disease progression or unacceptable toxicity.	Drug	BIBW 2992

Primary outcome

Overall Survival
Time frame: From randomization until death or the last patient out date, an average of 12 months
Overall survival was the duration from the date of randomization to the date of death. Patients who were alive were censored at the last contact date prior to the database lock. For the primary analysis 11 patients were lost to follow-up and were censored at the last contact date when they were known to be still alive. Primary analysis data cut-off date was 08 July 2010. For the final analysis 13 patients were lost to follow-up and were censored at the last contact date when they were known to be still alive. Final analysis data cut-off date was 04 October 2013.

2 secondary outcomes

Progression-free Survival (PFS)
Time frame: From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months
Objective Response Rate (OR)
Time frame: From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months

Results and safety

Results posted to the registry on 27 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Plus Best Supportive Care (BSC)	195	0
Afatinib 50 mg/Day Plus Best Supportive Care (BSC)	390	0

Primary outcome: Overall Survival

Time frame: From randomization until death or the last patient out date, an average of 12 months. Median (95% Confidence Interval). Unit: Months

Measure	Placebo Plus Best Supportive Care (BSC) n = 195	Afatinib 50 mg/Day Plus Best Supportive Care (BSC) n = 390
Primary analysis (358 deaths)	11.96 (10.15 to 14.26)	10.78 (9.95 to 11.99)
Final analysis (526 deaths)	11.73 (10.05 to 14.06)	10.87 (9.95 to 12.25)

Placebo Plus Best Supportive Care (BSC) vs Afatinib 50 mg/Day Plus Best Supportive Care (BSC): Hazard Ratio (HR): 1.077 (95% CI 0.862 to 1.346), p = 0.7428, Regression, Cox
Placebo Plus Best Supportive Care (BSC) vs Afatinib 50 mg/Day Plus Best Supportive Care (BSC): Hazard Ratio (HR): 0.976 (95% CI 0.814 to 1.170), p = 0.3955, Regression, Cox

Population analysed: Randomized set was all patients who were randomized and for this study all of these patients received at least one dose of study medication.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the date of first drug intake up to 28 days after the last drug intake for on-treatment adverse events or the last patient out date on 4 October 2013.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	36 of 195 (18.5%)	167 of 195 (85.6%)	Not reported
Afatinib 50 mg/Day	136 of 390 (34.9%)	383 of 390 (98.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22452896Miller VA, Hirsh V, Cadranel J, Chen YM, Park K, Kim SW, Zhou C, Su WC, Wang M, Sun Y, Heo DS, Crino L, Tan EH, Chao TY, Shahidi M, Cong XJ, Lorence RM, Yang JC. Afatinib versus placebo for patients with advanced, metastatic non-small-cell lung cancer after failure of erlotinib, gefitinib, or both, and one or two lines of chemotherapy (LUX-Lung 1): a phase 2b/3 randomised trial. Lancet Oncol. 2012 May;13(5):528-38. doi: 10.1016/S1470-2045(12)70087-6. Epub 2012 Mar 26.
Related InformationLink provided by the sponsor.

Related trials for Carcinoma, Non-Small-Cell Lung

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

90 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BIBW 2992 in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 90 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States, France, China, Germany, Taiwan and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: From randomization until death or the last patient out date, an average of 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00656136, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.