Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma

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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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

HOP d'Angers, Angers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

docetaxel

Drug

Nintedanib

Drug

Low Dose

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Jan 29, 2016
Registry last updated: Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed