Carcinoma, Non-Small-Cell LungPhase 3NCT02231164

LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research

A Phase 3 study testing docetaxel and nintedanib in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 13 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The present trial will investigate the efficacy and safety of nintedanib in combination with docetaxel as compared to placebo in combination with docetaxel in patients with stage IIIB/IV or recurrent NSCLC of adenocarcinoma histology after failure of first-line platinum-based chemotherapy. 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?: docetaxel and nintedanib
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: 13 sitesin 3 countries
Study dates: 14 Oct 2014to 24 Dec 2015
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

Male or female patients of at least 18 years of age
Histologically confirmed, adenocarcinoma of the lung, after failure of first line platinum-based chemotherapy.

Who cannot join

More than one prior line of chemotherapy (i.e., 2nd or 3rd line chemotherapy) for advanced and/or metastatic (stage III B or IV NSCLC) or recurrent disease.
Patients known to be positive for activating Epidermal Growth Factor Receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation
Previous therapy with other vascular endothelial growth factor (VEGF) or VEGFR inhibitors (other than bevacizumab) or docetaxel for the treatment of NSCLC at any time
Prior monotherapy with an EGFR inhibitor except as maintenance therapy

Trial locations and contacts

13 sites in 3 countries.

Country

City, postcode or hospital

13 sites in 3 countries

United States9 sites

1199.128.10077 Boehringer Ingelheim Investigational Site
Blacksburg, Virginia
1199.128.10032 Boehringer Ingelheim Investigational Site
Chandler, Arizona
1199.128.10016 Boehringer Ingelheim Investigational Site
Farmington, New Mexico
1199.128.10041 Boehringer Ingelheim Investigational Site
Fayetteville, Arkansas
1199.128.10010 Boehringer Ingelheim Investigational Site
Highland, California
1199.128.10011 Boehringer Ingelheim Investigational Site
Kennewick, Washington
1199.128.10013 Boehringer Ingelheim Investigational Site
Minot, North Dakota
1199.128.10080 Boehringer Ingelheim Investigational Site
Paducah, Kentucky
1199.128.10044 Boehringer Ingelheim Investigational Site
Rancho Mirage, California

Other trials in United States

Georgia3 sites

1199.128.64006 Boehringer Ingelheim Investigational Site
Batumi
1199.128.64001 Boehringer Ingelheim Investigational Site
Tbilisi
1199.128.64002 Boehringer Ingelheim Investigational Site
Tbilisi

Other trials in Georgia

Thailand1 site

1199.128.66004 Boehringer Ingelheim Investigational Site
Bangkok

Other trials in Thailand

About this study

Official title: Multicentre, Randomised, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral Nintedanib Plus Docetaxel Therapy Compared to Placebo Plus Docetaxel Therapy in Patients With Stage IIIB/IV or Recurrent, Adenocarcinoma Subtype Non-small Cell Lung Cancer After Failure of First Line Chemotherapy

Conditions: Carcinoma, Non-Small-Cell Lung
Being tested: docetaxel, placebo, nintedanib
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.

docetaxelDrug
intravenous chemotherapy drug
docetaxelDrug
intravenous chemotherapy drug
placeboDrug
oral placebo
nintedanibDrug
oral experimental therapy

Study groups in NCT02231164
Study group	Role	What they receive
Docetaxel and placebo	Placebo comparator	patients to receive backbone chemotherapy and placebo Receives: Drug: docetaxel; Drug: placebo
Docetaxel and Nintedanib	Experimental	patients to receive backbone chemotherapy and nintedanib Receives: Drug: docetaxel; Drug: nintedanib

What is being measured

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

Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1
This outcome measure presents the number of patients with disease control according to RECIST, version 1.1, defined as number of patients with Complete response, partial response or stable disease.
Measured: Up to 6 months.

Timeline

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

14 Oct 201424 Dec 2015

First posted4 Sep 2014 (estimated)
Study start14 Oct 2014
Primary completion24 Dec 2015
Study completion24 Dec 2015

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.
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: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02231164
Sponsor's protocol ID: 1199.128
Status last verified: Jan 2025
First submitted: 2 Sep 2014
Last updated: 13 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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)
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A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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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)
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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 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicentre, Randomised, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral Nintedanib Plus Docetaxel Therapy Compared to Placebo Plus Docetaxel Therapy in Patients With Stage IIIB/IV or Recurrent, Adenocarcinoma Subtype Non-small Cell Lung Cancer After Failure of First Line Chemotherapy
ClinicalTrials.gov ID: NCT02231164
Acronym / sponsor ID: 1199.128
Conditions: Carcinoma, Non-Small-Cell Lung
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 12 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 14 Oct 2014 (actual)
Primary completion: 24 Dec 2015 (actual)
Study completion: 24 Dec 2015 (actual)
First posted: 4 Sep 2014 (estimated)
Results: Posted 13 Feb 2017

Clinical summary

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

Study design

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

Arm	Type	Receives
Docetaxel and placebo	Placebo comparator	Drug: docetaxel, Drug: placebopatients to receive backbone chemotherapy and placebo
Docetaxel and Nintedanib	Experimental	Drug: docetaxel, Drug: nintedanibpatients to receive backbone chemotherapy and nintedanib

Who may qualify

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

Key inclusion criteria (2 listed)

Male or female patients of at least 18 years of age
Histologically confirmed, adenocarcinoma of the lung, after failure of first line platinum-based chemotherapy.

Key exclusion criteria (4 listed)

More than one prior line of chemotherapy (i.e., 2nd or 3rd line chemotherapy) for advanced and/or metastatic (stage III B or IV NSCLC) or recurrent disease.
Patients known to be positive for activating Epidermal Growth Factor Receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation
Previous therapy with other vascular endothelial growth factor (VEGF) or VEGFR inhibitors (other than bevacizumab) or docetaxel for the treatment of NSCLC at any time
Prior monotherapy with an EGFR inhibitor except as maintenance therapy

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
docetaxelintravenous chemotherapy drug	Drug	Docetaxel and Nintedanib
docetaxelintravenous chemotherapy drug	Drug	Docetaxel and placebo
placebooral placebo	Drug	Docetaxel and placebo
nintedaniboral experimental therapy	Drug	Docetaxel and Nintedanib

Primary outcome

Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1
Time frame: Up to 6 months.
This outcome measure presents the number of patients with disease control according to RECIST, version 1.1, defined as number of patients with Complete response, partial response or stable disease.

Results and safety

Results posted to the registry on 13 Feb 2017, 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	6	0
Nintedanib	6	0

Primary outcome: Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1

Time frame: Up to 6 months.. Number. Unit: Percentage of participants

Measure	Placebo n = 6	Nintedanib n = 6
Yes	66.7	50.0
No	33.3	50.0

Population analysed: Randomised Set: The randomised set included all randomised patients.

Adverse events

Time frame: From first drug administration until 28 days after last drug administration, up to 7 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 6 (50%)	5 of 6 (83.3%)	Not reported
Nintedanib	3 of 6 (50%)	6 of 6 (100%)	Not reported

Limitations and caveats (from the sponsor): The sponsor cancelled this trial prematurely. Thus, enrollment for 1199.128 was significantly less than what was planned (800 planned vs. 12 entered). Therefore, the objectives of this study could not be fully assessed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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

13 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing docetaxel and nintedanib in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 13 sites in 3 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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Georgia, Thailand. 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 13 Feb 2017). 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?

Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1 (time frame: Up to 6 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 NCT02231164.

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 13 Feb 2025.