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Lung NeoplasmsPhase 2REFRACTNCT02531737

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

A Phase 2 study testing vargatef® and Docetaxel in people with Lung Neoplasms, run by University Hospital, Limoges at 11 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Neoplasms
What is being tested?
vargatef® and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
11 sitesFrance
Study dates
Sep 2015to 26 Sep 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.
  • Antiplatelet treatment (aspirin authorized if < 325 mg/d)
  • Treatment with dipyridamole, ticlopidine, clopidogrel is not authorized
  • Women of child bearing potential must use double effective contraception.
  • Men might be surgically sterile or accept to use an effective contraceptive procedure during and until 6 months after the treatment.
  • Written informed consent to participate in the study.

Who cannot join

  • 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.
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  • 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
  • Active brain metastases (e.g. stable for <4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants; dexamethasone therapy will be allowed if administered as stable dose for at least one month before inclusion).
  • Uncontrolled arterial hypertension.
  • Concurrent radiotherapy, except for palliative bone irradiation.
  • Other concurrent severe illnesses (congestive heart failure, unstable angina, significant arrhythmia or myocardial infarction less than 12 months before study entry).
  • Stroke less than 6 months before study entry.
  • Psychiatric or neurological disorders preventing the patient from understanding the nature of the trial
  • Grade >=1 peripheral neuropathy
  • Uncontrolled infection.
  • Caval syndrome
  • Other organic disorders preventing inclusion in the trial
  • Malabsorption syndrome
  • Pregnancy and breast-feeding
  • Surgery less than two months before study entry.
  • Follow-up not feasible.
  • Incarcerated and institutionalized

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

France11 sites

  • CH de Beauvais

    Beauvais

  • CHU Brest

    Brest

  • Service de Pneumologie

    Créteil

  • Service de Pneumologie

    Gap

  • CHU de Limoges

    Limoges, 87000

  • CH de Bretagne Sud

    Lorient

  • Centre Hospitalier F. Quesnay

    Mantes-la-Jolie, 78200

  • AP-HM

    Marseille

  • Institut Paoli-Calmettes

    Marseille

  • Instiut de Cancérologie

    Saint-Etienne

  • Service de Pneumologie

    Villefranche

Other trials in France

About this study

Official title: Multicenter Phase II Trial of Nintedanib (Vargatef®) Plus Docetaxel in Second Line of Treatment in Patients With no Squamous Non Small Cell Lung Cancer Refractory to First Line Chemotherapy

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.

Read the detailed description

59 Patients with histologically documented stage IV NSCLC no squamous, after failure of first line chemotherapy and refractory (progressive disease during first line chemotherapy), will be enroled to receive docetaxel :75 mg/m² IV day 1 every 3 weeks with nintedanib (vargatef®):200 mg X 2/day per os day2-day21.

Tumor response (according to RECIST) will be assessed via computed tomography or magnetic resonance imaging scan every 6 weeks (evaluation of PFS) following completion of chemotherapy.

Adverse events (AEs) were graded according to the National Cancer Institute Common Toxicity Criteria, version 4.0

Quality of life(EQ5-D ) will be assessed every 6 weeks during chemotherapy. Tolerability will be assessed at each visit based on Common Terminology Criteria for Adverse Events (CTCAE), v4.0 criteria.

Total study duration per patient: approximately 12 months .

Conditions
Lung Neoplasms
Being tested
vargatef®, Docetaxel
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vargatef®Drug

    Also called Nintedanib

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

  • DocetaxelDrug

    Also called Taxotere

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

Study groups in NCT02531737
Study groupRoleWhat they receive
traitmentExperimentalPatients 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
Receives: Drug: vargatef®; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. median progression free survival

    Measured: 12 weeks

Secondary outcomes (4)

  1. median progression free survival

    Measured: 12 month

  2. Toxicity (NCIC-CTC version 4.0 criteria)

    Measured: Every 3 weeks during treatment up to 12 months from inclusion

  3. Quality of life (EQ5-D questionnaire)

    Measured: every 6 weeks up to 12 months from inlcusion

  4. Response rate

    Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2015 (estimated)
  2. Study startSep 2015
  3. Primary completion26 Sep 2020
  4. Study completion26 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02531737
Sponsor's protocol ID
I14041/REFRACT
Acronym
REFRACT
Status last verified
Jul 2019
First submitted
18 Aug 2015
Last updated
10 Aug 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing vargatef® and Docetaxel in people with Lung Neoplasms, run by University Hospital, Limoges at 11 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

median progression free survival (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02531737.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.

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