Carcinoma, Non-Small-Cell LungNCT02392455
VARGADO - Vargatef in 2nd-line Therapy of Non-Small Cell Lung Cancer (NSCLC)
An observational study of Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
This observational study will investigate the efficacy and tolerability of Vargatef (Nintedanib) plus docetaxel in daily routine second-line treatment in patients with locally advanced, metastatic or locally recurrent NSCLC. 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?
- treatment
- How many people
- 817 participants
- Where
- 1 siteGermany
- Study dates
- 23 Mar 2015to 23 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: NSCLC patients
Who may be able to join
- age 18 or older
- men and women locally advanced, metastastic and/or recurrent NSCLC with adenocarcinoma histology for which vargatef treatment is indicated according to Summary of Product Characteristics (SmPC)
- after first line chemotherapy. This includes also combinations of immune- and chemotherapy.
- standard 21-day-cycles docetaxel treatment according to SmPC possible
- written informed consent
Who cannot join
- contraindications according to the SmPC of Vargatef or Docetaxel
- more than one chemotherapy for treatment of NSCLC in palliative setting
- current partcipation in a clinical trial
- pregnancy
- breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vargatef in 2nd-line Therapy of Advanced or Metastatic Adenocarcinoma of the Lung
This observational study will investigate the efficacy and tolerability of Vargatef (Nintedanib) plus docetaxel in daily routine second-line treatment in patients with locally advanced, metastatic or locally recurrent NSCLC. Treatment with Vargatef in eligible NSCLC patients, for whom the treating physician has decided to initiate treatment with Vargatef in second line according to the local label, will be observed for up to 24 months. Survial follow-up will be done until the end of the study.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- treatment
- 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.
treatmentDrug
Docetaxel plus nintedanib until progression or intolerability
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients alive one year after start of therapy with Vargatef and Docetaxel (1-year survival rate)
Measured: up to 24 months
Secondary outcomes (6)
One year survival rate of patients with first line progression within 9 months after start of first line therapy
Measured: up to 24 months
Progression-free survival of patients with first line progression within 9 months after start of first line therapy
Measured: up to 24 months
Median overall survival
Measured: up to 24 months
Progression-free survival
Measured: up to 24 months
Tumour control rate (complete response, partial response, stable disease)
Measured: up to 24 months
Incidence of side effects
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study start23 Mar 2015
- Primary completion23 Jul 2025
- Study completion23 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 817 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392455
- Sponsor's protocol ID
- 1199.211
- Other IDs
- 1199-0211
- Status last verified
- Jul 2025
- First submitted
- 17 Mar 2015
- Last updated
- 28 Jul 2025
- Results posted
- No
- Individual data sharing
- Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets
Publications
Grohe C, Blau W, Gleiber W, Haas S, Hammerschmidt S, Kruger S, Muller-Huesmann H, Schulze M, Wehler T, Atz J, Kaiser R. Real-World Efficacy of Nintedanib Plus Docetaxel After Progression on Immune Checkpoint Inhibitors: Results From the Ongoing, Non-interventional VARGADO Study. Clin Oncol (R Coll Radiol). 2022 Jul;34(7):459-468. doi: 10.1016/j.clon.2021.12.010. Epub 2022 Jan 7.
PubMed 35012901Grohe C, Gleiber W, Haas S, Losem C, Mueller-Huesmann H, Schulze M, Franke C, Basara N, Atz J, Kaiser R. Nintedanib plus docetaxel after progression on immune checkpoint inhibitor therapy: insights from VARGADO, a prospective study in patients with lung adenocarcinoma. Future Oncol. 2019 Aug;15(23):2699-2706. doi: 10.2217/fon-2019-0262. Epub 2019 Jul 8.
PubMed 31282758
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vargatef in 2nd-line Therapy of Advanced or Metastatic Adenocarcinoma of the Lung
- ClinicalTrials.gov ID
- NCT02392455
- Acronym / sponsor ID
- 1199.211
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 817 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2015 (actual)
- Primary completion
- 23 Jul 2025 (actual)
- Study completion
- 23 Jul 2025 (actual)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study will investigate the efficacy and tolerability of Vargatef (Nintedanib) plus docetaxel in daily routine second-line treatment in patients with locally advanced, metastatic or locally recurrent NSCLC. Treatment with Vargatef in eligible NSCLC patients, for whom the treating physician has decided to initiate treatment with Vargatef in second line according to the local label, will be observed for up to 24 months. Survial follow-up will be done until the end of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NSCLC patients
Key inclusion criteria (5 listed)
- age 18 or older
- men and women locally advanced, metastastic and/or recurrent NSCLC with adenocarcinoma histology for which vargatef treatment is indicated according to Summary of Product Characteristics (SmPC)
- after first line chemotherapy. This includes also combinations of immune- and chemotherapy.
- standard 21-day-cycles docetaxel treatment according to SmPC possible
- written informed consent
Key exclusion criteria (5 listed)
- contraindications according to the SmPC of Vargatef or Docetaxel
- more than one chemotherapy for treatment of NSCLC in palliative setting
- current partcipation in a clinical trial
- pregnancy
- breastfeeding
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 |
|---|---|---|
| treatmentDocetaxel plus nintedanib until progression or intolerability | Drug | A |
Primary outcome
Percentage of patients alive one year after start of therapy with Vargatef and Docetaxel (1-year survival rate)
Time frame: up to 24 months
6 secondary outcomes
One year survival rate of patients with first line progression within 9 months after start of first line therapy
Time frame: up to 24 months
Progression-free survival of patients with first line progression within 9 months after start of first line therapy
Time frame: up to 24 months
Median overall survival
Time frame: up to 24 months
Progression-free survival
Time frame: up to 24 months
Tumour control rate (complete response, partial response, stable disease)
Time frame: up to 24 months
Incidence of side effects
Time frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Derived from this study: PubMed 35012901Grohe C, Blau W, Gleiber W, Haas S, Hammerschmidt S, Kruger S, Muller-Huesmann H, Schulze M, Wehler T, Atz J, Kaiser R. Real-World Efficacy of Nintedanib Plus Docetaxel After Progression on Immune Checkpoint Inhibitors: Results From the Ongoing, Non-interventional VARGADO Study. Clin Oncol (R Coll Radiol). 2022 Jul;34(7):459-468. doi: 10.1016/j.clon.2021.12.010. Epub 2022 Jan 7.
- Derived from this study: PubMed 31282758Grohe C, Gleiber W, Haas S, Losem C, Mueller-Huesmann H, Schulze M, Franke C, Basara N, Atz J, Kaiser R. Nintedanib plus docetaxel after progression on immune checkpoint inhibitor therapy: insights from VARGADO, a prospective study in patients with lung adenocarcinoma. Future Oncol. 2019 Aug;15(23):2699-2706. doi: 10.2217/fon-2019-0262. Epub 2019 Jul 8.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 1 site in Germany.
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 5 inclusion and 5 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 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of patients alive one year after start of therapy with Vargatef and Docetaxel (1-year survival rate) (time frame: up to 24 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 NCT02392455, which also lists 2 linked publications.
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 28 Jul 2025.