Carcinoma, Non-Small-Cell Lung, Immunotherapy
Conditions
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).
Interventions
DRUG(chemo)immunotherapy
Patients are receiving immunotherapy or chemoimmunotherapy as a standard of care
Sponsors
European Lung Cancer Working Party
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 - 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 |
| 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 |
Countries
Belgium
Contacts
Primary ContactThierry Berghmans, MD, PhD
Backup ContactBogdan Grigoriu, MD, PhD
Outcome results
None listed