Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-07

Study Completion Date

2019-11-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Level 0

Nintedanib low dose with docetaxel

Group Type OTHER

Docetaxel

Intervention Type DRUG

Nintedanib

Intervention Type DRUG

Low Dose

Level 1

Nintedanib medium dose with docetaxel

Group Type OTHER

Docetaxel

Intervention Type DRUG

Nintedanib

Intervention Type DRUG

Medium dose

Level 2

Nintedanib high dose with docetaxel

Group Type OTHER

Docetaxel

Intervention Type DRUG

Nintedanib

Intervention Type DRUG

High dose

Level 3

Nintedanib continuous high dose with docetaxel

Group Type OTHER

Docetaxel

Intervention Type DRUG

Nintedanib

Intervention Type DRUG

Continuous high dose

Interventions

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Docetaxel

Intervention Type DRUG

Nintedanib

Low Dose

Intervention Type DRUG

Nintedanib

Medium dose

Intervention Type DRUG

Nintedanib

High dose

Intervention Type DRUG

Nintedanib

Continuous high dose

Intervention Type DRUG

Eligibility Criteria

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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.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No