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Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02668393
Recruitment Status : Active, not recruiting
First Posted : January 29, 2016
Last Update Posted : October 15, 2019
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Docetaxel Drug: Nintedanib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 7, 2016
Estimated Primary Completion Date : November 12, 2019
Estimated Study Completion Date : November 12, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Level 0
Nintedanib low dose with docetaxel
Drug: Docetaxel
Drug: Nintedanib
Low Dose

Level 1
Nintedanib medium dose with docetaxel
Drug: Docetaxel
Drug: Nintedanib
Medium dose

Level 2
Nintedanib high dose with docetaxel
Drug: Docetaxel
Drug: Nintedanib
High dose

Level 3
Nintedanib continuous high dose with docetaxel
Drug: Docetaxel
Drug: Nintedanib
Continuous high dose

Primary Outcome Measures :
  1. Number of patients with Dose Limiting Toxicity (DLT) for nintedanib with weekly docetaxel during the first treatment cycle [ Time Frame: 4 weeks ]
  2. Maximum Tolerated Dose (MTD) of nintedanib in association with weekly docetaxel. [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

-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

Exclusion criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02668393

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HOP d'Angers
Angers, France, 49 933
HOP Jean Minjoz
Besançon, France, 25030
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
Großhansdorf, Germany, 22927
Krankenhaus Martha-Maria Halle-Dölau gGmbH
Halle/Saale, Germany, 06120
Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim Identifier: NCT02668393     History of Changes
Other Study ID Numbers: 1199.224
2015-000317-52 ( EudraCT Number )
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Adenocarcinoma of Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors