Immunotherapy in Lung Cancer: Treatment After IO Cessation.
- Conditions
- Carcinoma, Non-Small-Cell LungImmunotherapy
- Registration Number
- NCT04465942
- Lead Sponsor
- European Lung Cancer Working Party
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method to determine the therapeutic landscape after cessation of an immune checkpoint therapy From IO cessation date up to first treatment whatever the time in-between and up to 5 years Which treatment is proposed after IO cessation
- Secondary Outcome Measures
Name Time Method survival From IO cessation date up to death or up to 5 years 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 \[group 3\])
Activity of salvage therapy - response 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 Best response to first salvage chemotherapy after ICI
Disease-free survival From IO cessation to progression documentation or death or up to 5 years disease-free survival in untreated non-progressive patients after ICI cessation
second-line ICI effectiveness - response From initiation of second-line IO up to 2 years Response to second-line ICI (response rate) using WHO criteria
second-line ICI effectiveness - progression-free survival From initation of second-line ICI up to progression or death and up to 5 years PFS to second-line ICI
Activity of salvage therapy - progression-free survival From initation of salvage therapy up to progression or death and up to 5 years Progression-free survival to first salvage chemotherapy after ICI
Activity of salvage therapy - survival From initation of second-line ICI up to death and up to 5 years Survival to first salvage chemotherapy after ICI
Trial Locations
- Locations (5)
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
🇧🇪Brussels, Belgium
Department of Pneumology CHU Charleroi
🇧🇪Charleroi, Belgium
Hôpital Mont-Godinne
🇧🇪Yvoir, Belgium
Hôpital Ambroise Paré
🇧🇪Mons, Belgium
Department of Pneumology Hôpital Saint-Joseph
🇧🇪Gilly, Belgium