Nintedanib (Vargatef®) Plus Docetaxel in Second Line of Treatment in Patients With Lung Cancer

NCT02531737 | Completed Phase 2 DMC

• 1 other identifier: I14041/REFRACT
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 11

Brief Summary

The purpose of this study is to determine whether nintedanib (vargatef®) combined with docetaxel are effective in second line of treatment in patients with no squamous non small cell lung cancer refractory to first line chemotherapy.

Conditions

Lung Neoplasms

Outcome Measures

Primary Outcomes (1)

• median progression free survival

  12 weeks

Secondary Outcomes (4)

• median progression free survival

  12 month

• Toxicity (NCIC-CTC version 4.0 criteria)

  Every 3 weeks during treatment up to 12 months from inclusion

• Quality of life (EQ5-D questionnaire)

  every 6 weeks up to 12 months from inlcusion

• Response rate

  12 month

Study Arms (1)

traitment

EXPERIMENTAL

Patients will be treated to oral nintedanib (vargatef®) 400 mg/d on days 2 to 21 of a 3-week cycle including docetaxel 75 mg/m2 by intravenous infusion on day 1

Drug: vargatef®; Drug: Docetaxel

Interventions

vargatef® DRUG

Patients will be treated to oral nintedanib (vargatef®) 400 mg/d on days 2 to 21 of a 3-week cycle

Also known as: Nintedanib

traitment

Docetaxel DRUG

Patients will be treated to IV docetaxel 75 mg/m² on day 1 of evry 3-week cycle

Also known as: Taxotere

traitment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed non-squamous NSCLC,
• Metastatic NSCLC of stage IV (according to American Joint Committee on Cancers) or recurrent NSCLC)
• Patients without activating epidermal growth factor receptor (EGFR) mutation
• Patients without anaplastic lymphoma kinase (ALK) rearrangement
• Patients must have measurable lesion by RECIST 1.1
• Refractory disease defined by documented progression during the first-line chemotherapy based on a platinum doublet and third-generation drug (four or less cycles) according to RECIST V.1.1
• Age ≥18 years and \< 75 years
• Performance status (PS) 0-1
• Life expectancy of more than 12 weeks.
• No history of other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or basal cell or spinocellular carcinoma of the skin.
• Adequate organ function, evidenced by the following laboratory results within 3 weeks prior to randomization: Normal hepatic function: bilirubin \< 1.5 x N, ALT (alanine transaminase) and AST (aspartate aminotransferase ) \< 2.5 x N or \<5 x N in case of liver metastasis
• Normal renal function (calculated creatinine clearance ≥ 45 mL/min).
• Normal Calcemia
• Normal haematological function (polynuclear neutrophils \> 1.5 G/l, platelets \> 100 G/l).
• Anticoagulation with a vitamin K antagonist and low-molecular-weight heparin (LMWH) is authorized.

You may not qualify if:

• Known hypersensitivity to the trial drugs (nintedanib (vargatef®), docetaxel), peanut, soya, to their excipients
• Controlled disease after first line treatment
• Contra indication to the use of the backbone treatment
• Patients who were withdrawn from first line treatment due to toxicity without documented disease progression or who received placebo (in the context of a clinical trial) as prior treatment are not eligible.
• Previous treatment with docetaxel
• Small-cell lung cancer, bronchioloalveolar cancer, neuroendocrine cancer.
• Previous therapy with vascular endothelial growth factor (VEGF) inhibitors except bevacizumab
• Centrally located tumour with radiographic evidence of local invasion of local blood vessels
• Radiographic evidence of cavitary or necrotic tumours at screening
• Chemo-, hormone-, radio-(except for brain and extremities) or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks prior to treatment with the trial drug.
• Toxicity non resolute due to prior treatment \> grade I (except alopecia).
• Radiotherapy (except extremities) within the past 3 months prior to baseline imaging
• Persistence of clinically relevant therapy related toxicity from previous radiotherapy
• Uncontrolled arterial hypertension.
• Concurrent radiotherapy, except for palliative bone irradiation.

Sponsors & Collaborators

• University Hospital, Limoges: lead
• Boehringer Ingelheim: collaborator

Study Sites (11)

CH de Beauvais

Beauvais, France

Location

CHU Brest

Brest, France

Location

Service de Pneumologie

Créteil, France

Location

Service de Pneumologie

Gap, France

Location

CHU de Limoges

Limoges, 87000, France

Location

CH de Bretagne Sud

Lorient, France

Location

Centre Hospitalier F. Quesnay

Mantes-la-Jolie, 78200, France

Location

AP-HM

Marseille, France

Location

Institut Paoli-Calmettes

Marseille, France

Location

Instiut de Cancérologie

Saint-Etienne, France

Location

Service de Pneumologie

Villefranche, France

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

nintedanib; Docetaxel

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Alain Vergnenegre, MD

  CHU LImoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: August 24, 2015
• Study Start: September 1, 2015
• Primary Completion: September 26, 2020
• Study Completion: September 26, 2020
• Last Updated: August 10, 2021

Record last verified: 2019-07

Locations

FR (11)