Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma

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)

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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