Carcinoma, Non-Small-Cell LungPhase 1NCT02668393
Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma
A Phase 1 study testing Docetaxel and Nintedanib in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 4 sites in 2 countries.
Trial summary
Phase I study. To determine the MTD (Maximum Tolerated Dose) of nintedanib + weekly Docetaxel in patients with locally advanced or metastatic lung adenocarcinoma after failure of platinum-based first line 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 7 Mar 2016to 27 Nov 2019
- Phase
- Phase 1
- 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 histologically/ cytologically confirmed locally advanced (Stage IIIB) or metastatic (Stage IV) lung adeno carcinoma after failure of first line platinum - based chemotherapy (patients with non-target lesion only are eligible).
- First line chemotherapy may include continuation or switch maintenance therapy. One prior adjuvant and/or neoadjuvant chemotherapy line is accepted. Prior immunotherapy is allowed.
- ECOG inferior or equal to 1 at screening.
- Further inclusion criteria apply
Who cannot join
- Patients who have received more than one prior line of chemotherapy (i.e. second or third line chemotherapy) for advanced or metastatic NSCLC.
- Patients known to be positive for activating Epidermal Growth Factor Receptor (EGFR) mutation or patients known to be positive for ALK translocation
- Further exclusion criteria apply.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany2 sites
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927
Krankenhaus Martha-Maria Halle-Dölau gGmbH
Halle, 06120
About this study
Official title: An Open Label Phase I of Oral Nintedanib Plus Weekly Docetaxel Therapy in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma After Failure of Platinum -Based First Line Chemotherapy
Phase I study. To determine the MTD (Maximum Tolerated Dose) of nintedanib + weekly Docetaxel in patients with locally advanced or metastatic lung adenocarcinoma after failure of platinum-based first line chemotherapy.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Docetaxel, 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
NintedanibDrug
Low Dose
NintedanibDrug
Medium dose
NintedanibDrug
High dose
NintedanibDrug
Continuous high dose
| Study group | Role | What they receive |
|---|---|---|
| Level 0 | Other | Nintedanib low dose with docetaxel Receives: Drug: Docetaxel; Drug: Nintedanib |
| Level 1 | Other | Nintedanib medium dose with docetaxel Receives: Drug: Docetaxel; Drug: Nintedanib |
| Level 2 | Other | Nintedanib high dose with docetaxel Receives: Drug: Docetaxel; Drug: Nintedanib |
| Level 3 | Other | Nintedanib continuous high dose with docetaxel Receives: Drug: Docetaxel; Drug: Nintedanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Nintedanib Administered in Combination With Docetaxel
Maximum tolerated dose (MTD) of nintedanib administered in combination with docetaxel. The MTD was defined as the highest dose combination studied for which the incidence of DLTs was no more than 1 out of 6 subjects experiencing a DLT during the first treatment cycle i.e. the incidence of DLTs was no more than 17%. In case dose escalation reached dose level 3 (200 mg bid nintedanib administered without interruption on days of docetaxel infusion) and no more than 1 out of 6 subjects experienced a DLT during the first 28-day cycle at this dose level, dose level 3 was considered the MTD.
Measured: First treatment cycle, the first 28 days following the start of trial medication.
Number of Participants With Dose-limiting Toxicity (DLT) During the First Treatment Cycle
Number of participants with DLT occurring during the first treatment cycle. DLT was defined as any of the following adverse events related to nintedanib:
- Non-haematological drug-related Common Terminology Criteria for AEs (CTCAE) grade 3 or greater
- diarrhoea CTCAE grade 2 for >7 days despite supportive care
- nausea CTCAE grade 3 or greater despite supportive care
- vomiting CTCAE grade 2 or greater despite supportive care
- increase in Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) to CTCAE grade 3 or greater
- A increase in ALT and/or AST to CTCAE grade 2 or greater in conjunction with
- total bilirubin increase of CTCAE grade 1 or greater
- Platelets <50 000/mm3 with bleeding (CTCAE ≥3)
- neutropenia of any grade or duration accompanied by fever >38.5°C
- neutropenia grade 4 without fever of >7 days duration
- Inability to resume nintedanib dosing within 21 days after stopping due to toxicity.
Measured: First treatment cycle, the first 28 days following the start of trial medication.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study start7 Mar 2016
- Primary completion27 Nov 2019
- Study completion27 Nov 2019
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT02668393
- Sponsor's protocol ID
- 1199.224
- Other IDs
- 2015-000317-52, 2015
- Status last verified
- Jan 2021
- First submitted
- 27 Jan 2016
- Last updated
- 29 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase I of Oral Nintedanib Plus Weekly Docetaxel Therapy in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma After Failure of Platinum -Based First Line Chemotherapy
- ClinicalTrials.gov ID
- NCT02668393
- Acronym / sponsor ID
- 1199.224
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2016 (actual)
- Primary completion
- 27 Nov 2019 (actual)
- Study completion
- 27 Nov 2019 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Posted 29 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I study. To determine the MTD (Maximum Tolerated Dose) of nintedanib + weekly Docetaxel in patients with locally advanced or metastatic lung adenocarcinoma after failure of platinum-based first line chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Level 0 | Other | Drug: Docetaxel, Drug: NintedanibNintedanib low dose with docetaxel |
| Level 1 | Other | Drug: Docetaxel, Drug: NintedanibNintedanib medium dose with docetaxel |
| Level 2 | Other | Drug: Docetaxel, Drug: NintedanibNintedanib high dose with docetaxel |
| Level 3 | Other | Drug: Docetaxel, Drug: NintedanibNintedanib continuous high dose with docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- -Patients with histologically/ cytologically confirmed locally advanced (Stage IIIB) or metastatic (Stage IV) lung adeno carcinoma after failure of first line platinum - based chemotherapy (patients with non-target lesion only are eligible).
- First line chemotherapy may include continuation or switch maintenance therapy. One prior adjuvant and/or neoadjuvant chemotherapy line is accepted. Prior immunotherapy is allowed.
- ECOG inferior or equal to 1 at screening.
- Further inclusion criteria apply
Key exclusion criteria (3 listed)
- Patients who have received more than one prior line of chemotherapy (i.e. second or third line chemotherapy) for advanced or metastatic NSCLC.
- Patients known to be positive for activating Epidermal Growth Factor Receptor (EGFR) mutation or patients known to be positive for ALK translocation
- Further exclusion criteria apply.
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 |
|---|---|---|
| Docetaxel | Drug | Level 0, Level 1, Level 2, Level 3 |
| NintedanibLow Dose | Drug | Level 0 |
| NintedanibMedium dose | Drug | Level 1 |
| NintedanibHigh dose | Drug | Level 2 |
| NintedanibContinuous high dose | Drug | Level 3 |
Primary outcome
Maximum Tolerated Dose (MTD) of Nintedanib Administered in Combination With Docetaxel
Time frame: First treatment cycle, the first 28 days following the start of trial medication.
Maximum tolerated dose (MTD) of nintedanib administered in combination with docetaxel. The MTD was defined as the highest dose combination studied for which the incidence of DLTs was no more than 1 out of 6 subjects experiencing a DLT during the first treatment cycle i.e. the incidence of DLTs was no more than 17%. In case dose escalation reached dose level 3 (200 mg bid nintedanib administered without interruption on days of docetaxel infusion) and no more than 1 out of 6 subjects experienced a DLT during the first 28-day cycle at this dose level, dose level 3 was considered the MTD.
Number of Participants With Dose-limiting Toxicity (DLT) During the First Treatment Cycle
Time frame: First treatment cycle, the first 28 days following the start of trial medication.
Number of participants with DLT occurring during the first treatment cycle. DLT was defined as any of the following adverse events related to nintedanib: * Non-haematological drug-related Common Terminology Criteria for AEs (CTCAE) grade 3 or greater * diarrhoea CTCAE grade 2 for >7 days despite supportive care * nausea CTCAE grade 3 or greater despite supportive care * vomiting CTCAE grade 2 or greater despite supportive care * increase in Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) to CTCAE grade 3 or greater * A increase in ALT and/or AST to CTCAE grade 2 or greater in conjunction with * total bilirubin increase of CTCAE grade 1 or greater * Platelets <50 000/mm3 with bleeding (CTCAE ≥3) * neutropenia of any grade or duration accompanied by fever >38.5°C * neutropenia grade 4 without fever of >7 days duration * Inability to resume nintedanib dosing within 21 days after stopping due to toxicity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Docetaxel and Nintedanib in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 4 sites in 2 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 4 inclusion and 3 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 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 29 Jan 2021). 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?
Maximum Tolerated Dose (MTD) of Nintedanib Administered in Combination With Docetaxel (time frame: First treatment cycle, the first 28 days following the start of trial medication.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2021.