Clinical trial NCT04944030: Clinico-biological Data Collection Study of Metastatic Lung Cancer
Official title: Prediction in Silico of Therapeutic Response in a Prospective Cohort Study of Metastatic Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: Lung cancer
Prospective clinico-biological database
Multi omic analysis
Prediction in silico
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: RATIONALE : Currently, the mechanisms associated with the response or resistance to treatment are poorly understood and are multifactorial. These mechanisms involve clinical and biological factors associated with the host and the tumor and possibly the patient's psycho-social environment.

PURPOSE : This trial will assess the use of a prospective database dedicated to patients with breast cancers that contains clinical data as well as epidemiological, psychological, emotional, social, imaging, biological and biopathological data. These data will allow a creation of new modelling algorithms in order to predict response and resistance to treatment.

Detailed description: This prospective study will be conducted on first line metastatic lung cancer patients. Three phenotypic groups are identified on immunohistochemistry done at inclusion: on metastatic sites or lung tumor if local recurrence, usual treatment protocols are often guided by the following groups:

* For group 1: SCLC (small cell lung cancer)

  * Carbo or cisplatin + etoposide chemotherapy associated to atezolizumab or durvalumab
* For group 2: NSCLC (no small cell lung cancer) without oncogenic addiction:

  * Adenocarcinoma, NOS, sarcomatoïd carcinoma or large cell carcinoma with PDL1 expression level ≥ 50%: Carbo/cisplatin + pemetrexed + pembrolizumab or pembrolizumab alone.

In case of contra indication of pembrolizumab, treatment will be based on doublet of chemotherapy with platinum salt +/- bevacizumab - Adenocarcinoma, NOS, sarcomatoïde carcinoma or large cell carcinoma with PDL1 expression level \< 50%: Carbo/cisplatin + pemetrexed + pembrolizumab.

In case of contra indication of pembrolizumab, treatment will be based on doublet of chemotherapy with platinum salt +/- bevacizumab

- Squamous cell carcinoma with PDL1 ≥ 50%: Carboplatin + paclitaxel + pembrolizumab or pembrolizumab alone.

In case of contra indication of pembrolizumab, treatment will be based on doublet of chemotherapy with platinum salt - Squamous cell carcinoma with PDL1 \< 50%: Carboplatin + paclitaxel + pembrolizumab or pembrolizumab alone.

In case of contra indication of pembrolizumab, treatment will be based on doublet of chemotherapy with platinum salt

• For group 3: NSCLC NSCLC (no small cell lung cancerwith oncogenic addiction (KRAS G12c/BRAFV600E/NTRK/ROS1/ALK/EGFR/RET/NTRK/HER2):

* For which TKI is indicated: TKI as long as possible
* If TKI is not indicated: doublet of chemotherapy with platinum salt +/- pembrolizumab or pembrolizumab alone for PDL1 ≥ 50% or doublet of chemotherapy +/- bevacizumab

Further treatment lines are administered according to standard practice. Biological and histological assessments are performed on specific metastasis biopsy samples done at baseline and at each progression.

Physical exam, standard laboratory tests, imaging (CT (computerized tomography) scan, PET-CT (Positron emission tomography-computed tomography) and bone scan (for patients with bone metastasis) will be performed every 2 to 3 months according to patient group. Clinical, biological, pathological, epidemiological, socio-economic and multiomic data will be collected throughout the study duration. These massive data will be used to create new algorithms in order to help clinicians to predict treatment response

Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening biopsy, blood sample, faeces and questionnaires
* 18 years old at time of written consent
* Patient with histologically confirmed lung cancer
* Lung cancer metastatic disease or locally advanced not eligible for local curative treatment intent
* Patient with metastases that can be biopsied.
* Performance status ≤ 2 (according to WHO criteria)
* At least one measurable target on CT scan according to RECIST 1.1
* Indication of any systemic therapeutic strategy can be performed alongside this current cohort in accordance with national and / or international recommendations.
* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
* Patient must be affiliated to a Social Health Insurance

Exclusion Criteria:

* Other malignancy treated within the last 3 years (except non-melanoma skin cancer or in situ carcinoma of the cervix)
* Other neuroendocrine tumour than small cell or large cell carcinoma.
* Coagulopathy or other pathology that contraindicates biopsy procedures
* Pregnant or nursing patient
* Individual deprived of liberty or placed under the authority of a tutor
* Impossibility to submit to the medical follow-up of this clinical trial for geographical, social or psychological reasons

Primary outcomes:
measure: Overall survival
timeFrame: 15 years
Secondary outcomes:
measure: To describe response to treatment for each therapeutic sequence
timeFrame: 15 years
measure: To evaluate progression free survival (PFS) for each therapeutic sequence
timeFrame: 15 years
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancerologie de L'Ouest
city: St Herblain
country: France
facility: Institut de Cancerologie de L'Ouest
Study officials:
affiliation: judith.raimbourg@ico.unicancer.fr
name: JUDITH RAIMBOURG, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: