Trial Title:
Trial for Local Ablative Treatment (LAT) Optimization in Patients With Advanced Non-Small Cells Lung Cancer (NSCLC) Presenting an Anaplastic Lymphoma Kinase (ALK) Rearrangement Treated by Brigatinib
NCT ID:
NCT06620835
Condition:
NSCLC
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
NSCLC
Lung cancer
ALK rearrangement
gene mutation
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Blood samples for Hematology
Description:
Complete blood count will include erythrocytes, neutrophils, eosinophils, basophils,
lymphocytes, monocytes, platelets, leukocytes, hemoglobin, hematocrit.
Arm group label:
Clinical Trial population
Intervention type:
Biological
Intervention name:
Blood samples for Chemistry
Description:
Clinical chemistry will include serum electrolytes (sodium, potassium, calcium, corrected
calcium for hypoalbuminemia), creatinine, CrCl with local formula, and fasting blood
glucose.
Arm group label:
Clinical Trial population
Intervention type:
Biological
Intervention name:
Blood sample for liver function tests
Description:
Laboratory tests to assess liver function will include Aminotransferase Alanine (ALAT),
Aminotransferase Aspartate (ASAT), Phosphatase Alkaline (ALP), Gamma-glutamyl Transferase
(GGT), total and conjugated bilirubin.
Arm group label:
Clinical Trial population
Intervention type:
Biological
Intervention name:
Pregnancy test
Description:
Pregnancy test will be performed in women of childbearing potential, including women who
have had a tubal ligation. Childbearing potential is defined as not having undergone
surgical sterilization, hysterectomy, and/or bilateral oophorectomy or not being
postmenopausal (≥12 months of amenorrhea). Urine pregnancy tests will be based on the
measurement of β-Human Chorionic Gonadotropin (HCG). If a urine pregnancy test is
positive, it must be confirmed by a serum pregnancy test. Urine pregnancy tests will be
performed at screening.
Arm group label:
Clinical Trial population
Intervention type:
Procedure
Intervention name:
Tumour assessment
Description:
Tumor assessment according to the RECIST v1.1 include the following radiological
evaluation: thoracic CT scan, brain MRI or CT scan (MRI is preferred), abdominopelvic
scan, PET-CT scan mandatory and at the Investigator's discretion, if needed bone
scintigraphy and chest X-ray.
Arm group label:
Clinical Trial population
Intervention type:
Procedure
Intervention name:
Local Ablative Therapy (LAT)
Description:
Local Ablative Treatment (LAT) (stereotactic body radiotherapy, surgery, thermal
ablation)
Arm group label:
Clinical Trial population
Summary:
The goal of this clinical trial is to learn if the treatment by systemic Brigatinib
(ALUNBRIG®) associated to local ablative therapy (LAT) treatment is improved if
administered when the brigatinib works best in participants presenting an advanced
non-small cells lung cancer with an ALK gene anomaly (this anomaly produces a defective
protein that is responsible for the multiplication of cancer cells).
This clinical trial is expected to involve 45 participants in several sites in France.
Advanced non-small cell lung cancer (NSCLC) participants with ALK rearrangements treated
with brigatinib in first line of non-curable setting will be screened.
If the disease assessment done between 3 to 9 months after initiation of brigatinib
shows:
- a tumor response or stabilization (according to RECIST 1.1)
- a disease which meets the definition of an oligometastatic disease (five metastatic
lesions or less and a maximum of two lesions per organ)
- all tumor targets are accessible to a local ablative therapy (confirmed by an expert
panel of clinicians before inclusion): surgery, stereotactic radiosurgery (SRS). For
liver, adrenal, or other metastases, percutaneous thermal ablation will be accepted.
Participants will be asked to visit the clinic:
- for eligibility criteria assessment prior to LAT
- for LAT
- every 8 weeks for checkups and tests the first year after LAT
- and then every 12 weeks, for a maximum period of 3 years.
Eligible patients will benefit from local ablative therapy with continuation of
brigatinib.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 18 years or older at diagnosis.
- Stage 3 non eligible for chemoradiotherapy or stage 4 NSCLC, histologically or
cytologically confirmed NSCLC.
- Tyrosine Kinase Inhibitor (TKI) treatment naïve.
- ALK rearrangements identified by a validated technique (either Immunohistochimy
(IHC), fluorescence in situ hybridization (FISH) or Ribonucleic Acid (RNA)seq, in
tissue or liquid biopsy)
- Stable disease or response after initiation brigatinib treatment (at least 3 to 9
months) according to RECIST 1.1
- At least one site of residual site for LAT (ie. participant should not have a
complete response)
- Oligometastatic disease (five metastatic lesions or less and a maximum of two
lesions per organ) de novo or induced
- Eligible for local ablative treatment possible (either alone or combined): surgery,
minimally invasive form of surgical radiosurgery (Stereotactic Radio Surgery (SRS))
(18 to 20 Gy in single fraction) or radiotherapy (SBRT) (27 to 54 Gy in 3 fractions
or 45 to 50 Gy in 5 fractions), radiofrequency or cryotherapy (=thermoablation)
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2.
- Life expectancy above 12 weeks as assessed by treating investigator.
- Brain metastases at inclusion are allowed if asymptomatic
- No history of other malignant tumor during the previous 5 years, except for
adequately treated carcinomas (in situ cervical carcinoma, basal cell carcinoma,
squamous cell skin carcinoma) and low-grade localized prostate cancer (Gleason
<6).
- Adequate organ function, as demonstrated by laboratory results prior to the first
administration of study treatment: normal hepatic function (bilirubin ≤1.5 x upper
limit of normal (ULN), alanine aminotransferase (ALA T) and aspartate
aminotransferase (ASAT) ≤2.5 x ULN or ≤5 x ULN in case of liver metastases), renal
function (calculated creatinine clearance (CrCl, using local formula) above 45
ml/mn), normal hematological function (absolute neutrophil count
≥1.5 x 109/L and/or platelets ≥100 x 109/L, hemoglobin ≥8 g/dL), normal coagulation
function (International Normalized Ratio (INR) or prothrombin time ≤1.5 x ULN and
activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT)
≤1.5 x ULN unless the patient is receiving anticoagulant therapy)
- For patients of childbearing potential: Women of childbearing potential should use
effective non-hormonal contraception during treatment with brigatinib and for at
least 4 months following the final dose. Men with female partners of childbearing
potential should use effective contraception during treatment and for at least 3
months after the last dose of brigatinib.
- Signed informed consent to participate in the study
- Affiliation with or benefit from French social security
Exclusion Criteria:
- NSCLC without known ALK rearrangements
- Neuroendocrine tumor (even in case of mixed tumors).
- Uncontrolled and untreated superior cava syndrome.
- Unstable symptomatic brain metastases despite corticosteroid
- Leptomeningeal, pericardial, pleural and mesenteric lesions, lymphangitic spread
(any tumoral lesions not amenable to definitive local therapy). Peri tumoral
lymphangitic spread around a tumor, but limited to a lobe, may be treated by
surgery).
- Serious concurrent conditions during the previous 6 months (severe or unstable
angina pectoris, coronary or peripheral artery bypass graft of <6 months, class 3
or 4 congestive heart failure, ischemic stroke, grade ≥2 peripheral neuropathy,
psychiatric or neurological disorders that may interfere with the patient's
understanding of the study or with his/her informed consent.
- Severe or non-controlled systemic diseases deemed incompatible with the protocol.
- Severe infections within 4 weeks prior to inclusion, including, but not limited to,
hospitalization for complications of infection, bacteremia, or severe pneumonia.
- Psychological, family, social, or geographical factors that may interfere with the
monitoring of the patient as defined by the protocol.
- Any protected person (legal person protected by legal protection [guardianship,
tutorship], person deprived of liberty, pregnant woman, breastfeeding woman, and
minor).
- Patients who participated in other concomitant studies unless observational and
received study therapy or used an investigational device within 4 weeks prior to
start of study treatment
- Known allergies or adverse reactions to the study drugs
- Lung function not compatible with surgery or radiation
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU de Brest
Address:
City:
Brest
Zip:
29200
Country:
France
Contact:
Last name:
François LUCIA
Email:
francois.lucia@chu-brest.fr
Facility:
Name:
Centre François Baclesse
Address:
City:
Caen
Zip:
14000
Country:
France
Contact:
Last name:
Hubert CURCIO
Email:
h.curcio@baclesse.unicancer.fr
Facility:
Name:
CH Métropole-Savoie
Address:
City:
Chambery
Zip:
73000
Country:
France
Facility:
Name:
Hôpital Louis Pasteur
Address:
City:
Colmar
Zip:
68000
Country:
France
Facility:
Name:
Pneumologie Centre Hospitalier Intercommunal de Créteil
Address:
City:
Creteil
Zip:
94010
Country:
France
Facility:
Name:
Polyclinique de Blois
Address:
City:
La Chaussee Saint Victor
Zip:
41260
Country:
France
Facility:
Name:
CHD les Oudaries
Address:
City:
La Roche-sur-Yon
Zip:
85000
Country:
France
Facility:
Name:
CHU Dupuytren
Address:
City:
Limoges
Zip:
87042
Country:
France
Facility:
Name:
Centre Leon Bérard
Address:
City:
Lyon
Zip:
69373
Country:
France
Facility:
Name:
Hôpital Nord
Address:
City:
Marseille
Zip:
13915
Country:
France
Facility:
Name:
CHU Orléans
Address:
City:
Orléans
Zip:
45067
Country:
France
Contact:
Last name:
Yan-Min XU
Email:
yan-min.xu@chu-orleans.fr
Facility:
Name:
CHU de Bordeaux Haut Lévêque
Address:
City:
Pessac
Zip:
33800
Country:
France
Facility:
Name:
CHU Ponchailloux
Address:
City:
Rennes
Zip:
35033
Country:
France
Contact:
Last name:
Thomas GOTER
Email:
thomas.goter@chu-rennes.fr
Facility:
Name:
Hôpital Charles Nicolle
Address:
City:
Rouen
Zip:
76031
Country:
France
Facility:
Name:
Pneumologie CHU St Etienne
Address:
City:
Saint-etienne
Zip:
42270
Country:
France
Facility:
Name:
CHU de la Réunion
Address:
City:
Saint-pierre
Zip:
97410
Country:
France
Facility:
Name:
Centre Paul Strauss
Address:
City:
Strasbourg
Zip:
67065
Country:
France
Facility:
Name:
HIA St Anne
Address:
City:
Toulon
Zip:
83800
Country:
France
Facility:
Name:
CH Bretagne Atlantique
Address:
City:
Vannes
Zip:
56017
Country:
France
Facility:
Name:
Centre Hospitalier de Villefranche sur Saone
Address:
City:
Villefranche Sur Saone
Zip:
69655
Country:
France
Facility:
Name:
CH Annecy
Address:
City:
Épagny
Zip:
74370
Country:
France
Contact:
Last name:
Stéphanie HOMINAL
Email:
shominal@ch-annecygenevois.fr
Start date:
October 1, 2024
Completion date:
October 1, 2030
Lead sponsor:
Agency:
Groupe Francais De Pneumo-Cancerologie
Agency class:
Other
Source:
Groupe Francais De Pneumo-Cancerologie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06620835
