Epidemiologic Multicenter Prospective Study in Advanced NSCLC (Non Small Cell Lung Cancer) Patients With PDL1 (Protein Death Ligand 1) Expression. (EXPLORE-PDL1)

Groupe Francais De Pneumo-Cancerologie

Status: Completed

Conditions: Lung Cancer

Treatments: Other: Assessment of PDL1 expression

Study type: Interventional

Funder types: Other

Identifiers

NCT02785562

GFPC 06-2015

Details and patient eligibility

About

Epidemiologic multicenter prospective study in advanced NSCLC patients with PDL1 expression : evaluation of clinical and pathological characteristics of PDL1 high expression patients compared to patients with a weak or no expression of PDL1.

Full description

Few data are published on the clinical and pathological characteristics of advanced NSCLC with high PDL1 expression compare to weak and no expression populations.

There is not for the moment a standard test to determine a relevant target population. Preliminary data showed that around 25% of the NSCLC population may have a high PDL1 expression and may have a greater benefit of anti PDL1 therapy. But in fact limited data have been published in European populations on the clinical and pathological characteristics (high PDL1 expression) compared to the weak expression and no expression populations. More over the prognosis rule of a high PDL1 expression in NSCLC is not definitive, with some studies indicating it is a positive prognostic factor while other studies showing that it is a negative prognostic factor.

To understand if there are differences in terms of prognostic between advanced NSCLC with high and low/no expression of PDL1 is a major challenge for the future management strategy of these patients. The results of this study should helps to elaborate new guidelines for this population. Therefore is also important to had data's on the natural course of the disease in these population for building cost effectiveness models of new immune therapies.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18 years or more

  • With locally advanced stage (IIIb) to stage IV NSCLC - Non Small Cell Lung Cancer -
  • Histological diagnostic :

• No known Epidermal Growth Factor Receptor (EGFR) or Anaplastic Lymphoma Kinase (ALK) / Reactive Oxygen Species (ROS) translocation

• At least 2 slides of tumoral sample available

  • No previous chemotherapy treatment. Neo or adjuvant therapy is allowed if done at least one year before inclusion
  • Performance Status ( PS) 0/1

Planned to receive a platin based standard treatment (cisplatin or carboplatin with bevacizumab (restricted to no squamous) pemetrexed(restricted to no squamous) , gemcitabine, vinorelbine, docetaxel or taxol, on first line setting, in standard dose

• A RECIST - Response Evaluation Criteria In Solid Tumor - target lesion

Exclusion criteria

• Age fewer than 18
• Pregnancy
• Known immune deficit
• PS > 1
• Inclusion in a clinical therapeutic trial in first line
• Patient treated with Protein D1/Protein Death Ligang1 (PD1/PDL1) therapy on first line setting.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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170 participants in 1 patient group

Assessment of PDL1 expression

Other group

Description:

Other : assess clinical and pathological characteristics of PDL1 expression in Non Small Cell Lung Cancer patients.

Treatment:

Other: Assessment of PDL1 expression