Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma

Boehringer Ingelheim logo

Boehringer Ingelheim

Status and phase

Completed
Phase 1

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: Docetaxel
Drug: Nintedanib

Study type

Interventional

Funder types

Industry

Identifiers

NCT02668393
2015-000317-52 (EudraCT Number)
1199.224

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

14 participants in 4 patient groups

Level 0
Other group
Description:
Nintedanib low dose with docetaxel
Treatment:
Drug: Nintedanib
Drug: Docetaxel
Level 1
Other group
Description:
Nintedanib medium dose with docetaxel
Treatment:
Drug: Nintedanib
Drug: Docetaxel
Level 2
Other group
Description:
Nintedanib high dose with docetaxel
Treatment:
Drug: Nintedanib
Drug: Docetaxel
Level 3
Other group
Description:
Nintedanib continuous high dose with docetaxel
Treatment:
Drug: Nintedanib
Drug: Docetaxel

Trial documents
2

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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