Immunotherapy in Lung Cancer: Treatment After IO Cessation.

European Lung Cancer Working Party300 enrolled

Overview

Immunotherapy is now a standard of care for first-line and eventually salvage therapy in patients with stage IV NSCLC and as adjuvant after RT-CT for stage III NSCLC. The aim of the study is determining the therapeutic landscape and the reason for immunotherapy cessation.

Patients with stage IV or unresectable not irradiable stage III NSCLC will be registered at the time receiving immunotherapy alone or in combination with chemotherapy. When IO is stopped, reason for cessation and further treatment will be recorded. Secondary endpoints are survival after IO cessation, activity of first salvage therapy, disease-free survival after IO cessation in patients receiving no further treatment. Patients will be centrally registered at the ELCWP headquarter (Institut Jules Bordet, Brussels, Belgium).

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Carcinoma, Non-Small-Cell Lung Immunotherapy

Interventions

(chemo)immunotherapyDRUG

Patients are receiving immunotherapy or chemoimmunotherapy as a standard of care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histological diagnosis of non-small cell lung cancer (NSCLC) * Stage IVA/IVB and unresectable and non irradiable stage III NSCLC naïve of immunotherapy. * Patients who receive immunotherapy (any type) monotherapy, combined immunotherapy or in combination with chemotherapy for first or second-line treatment. * Availability for participating in the detailed follow-up of the protocol. * Signed informed consent. Exclusion Criteria: * Patients receiving adjuvant immunotherapy for stage I-III NSCLC are not eligible * Tumours for which TNM stage at time of study inclusion cannot be assessed. * History of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or of the bladder or cured malignant tumor (more than 5-year disease free interval). * Any type of immunotherapy for previous cancer

Locations (5)

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet

Brussels, Belgium

RECRUITING

Department of Pneumology CHU Charleroi

Charleroi, Belgium

NOT_YET_RECRUITING

Department of Pneumology Hôpital Saint-Joseph

Gilly, Belgium

Outcomes

Primary Outcomes

to determine the therapeutic landscape after cessation of an immune checkpoint therapy

Which treatment is proposed after IO cessation

Time frame: From IO cessation date up to first treatment whatever the time in-between and up to 5 years

Secondary Outcomes

survival

survival after ICI cessation, overall and in pre-defined subgroups (cessation for progressive disease \[group 1\], for toxicity \[group 2\], by patient decision without progression \[group 3\])

Time frame: From IO cessation date up to death or up to 5 years

Activity of salvage therapy - response

Best response to first salvage chemotherapy after ICI

Time frame: At the end of cycle 2 or 3 (according to routine local practice), one cycle corresponding to 21 days, up to 6 cycles. assessment will done according to RECIST criteria

Disease-free survival

disease-free survival in untreated non-progressive patients after ICI cessation

Time frame: From IO cessation to progression documentation or death or up to 5 years

second-line ICI effectiveness - response

Response to second-line ICI (response rate) using WHO criteria

Time frame: From initiation of second-line IO up to 2 years

second-line ICI effectiveness - progression-free survival

PFS to second-line ICI

Time frame: From initation of second-line ICI up to progression or death and up to 5 years

Activity of salvage therapy - progression-free survival