Clinical trial NCT04465942: Immunotherapy in Lung Cancer: Treatment After IO Cessation.
Official title: Immunotherapy in Lung Cancer: Which Treatment After Immunotherapy Cessation: A Prospective Registry From the European Lung Cancer Working Party
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma, Non-Small-Cell Lung
Immunotherapy
Lead sponsor: European Lung Cancer Working Party
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stage IV or unresectable and non irradiable NSCLC, naïve of immunotherapy and receiving immunotherapy alone or combined chemo-immunotherapy

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: to determine the therapeutic landscape after cessation of an immune checkpoint therapy
timeFrame: From IO cessation date up to first treatment whatever the time in-between and up to 5 years
Secondary outcomes:
measure: survival
timeFrame: From IO cessation date up to death or up to 5 years
measure: Activity of salvage therapy - response
timeFrame: 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
measure: Disease-free survival
timeFrame: From IO cessation to progression documentation or death or up to 5 years
measure: second-line ICI effectiveness - response
timeFrame: From initiation of second-line IO up to 2 years
measure: second-line ICI effectiveness - progression-free survival
timeFrame: From initation of second-line ICI up to progression or death and up to 5 years
measure: Activity of salvage therapy - progression-free survival
timeFrame: From initation of salvage therapy up to progression or death and up to 5 years
measure: Activity of salvage therapy - survival
timeFrame: From initation of second-line ICI up to death and up to 5 years
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
city: Charleroi
country: Belgium
facility: Department of Pneumology CHU Charleroi
city: Gilly
country: Belgium
facility: Department of Pneumology Hôpital Saint-Joseph
city: Mons
country: Belgium
facility: Hôpital Ambroise Paré
city: Yvoir
country: Belgium
facility: Hôpital Mont-Godinne
Study officials:
affiliation: ELCWP
name: Thierry Berghmans, MD, PhD
role: STUDY_CHAIR
References: