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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (chemo)immunotherapy | Drug | Patients are receiving immunotherapy or chemoimmunotherapy as a standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| to determine the therapeutic landscape after cessation of an immune checkpoint therapy | Which treatment is proposed after IO cessation | From IO cessation date up to first treatment whatever the time in-between and up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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]) | From IO cessation date up to death or up to 5 years |
| Activity of salvage therapy - response |
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Inclusion Criteria:
Exclusion Criteria:
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Stage IV or unresectable and non irradiable NSCLC, naïve of immunotherapy and receiving immunotherapy alone or combined chemo-immunotherapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thierry Berghmans, MD, PhD | Contact | 003225413191 | thierry.berghmans@bordet.be | |
| Bogdan Grigoriu, MD, PhD | Contact | 003225413191 | bogdan.grigoriu@bordet.be |
| Name | Affiliation | Role |
|---|---|---|
| Thierry Berghmans, MD, PhD | ELCWP | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet | Recruiting | Brussels | 1000 | Belgium |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D000068437 | Pemetrexed |
| D017239 | Paclitaxel |
| C582435 | pembrolizumab |
| D000077594 | Nivolumab |
| C000594389 | atezolizumab |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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Best response to first salvage chemotherapy after ICI |
| 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 | 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 | From initiation of second-line IO up to 2 years |
| second-line ICI effectiveness - progression-free survival | PFS to second-line ICI | From initation of second-line ICI up to progression or death and up to 5 years |
| Activity of salvage therapy - progression-free survival | Progression-free survival to first salvage chemotherapy after ICI | From initation of salvage therapy up to progression or death and up to 5 years |
| Activity of salvage therapy - survival | Survival to first salvage chemotherapy after ICI | From initation of second-line ICI up to death and up to 5 years |
| Department of Pneumology CHU Charleroi | Not yet recruiting | Charleroi | 6000 | Belgium |
|
| Department of Pneumology Hôpital Saint-Joseph | Not yet recruiting | Gilly | 6060 | Belgium |
|
| Hôpital Ambroise Paré | Not yet recruiting | Mons | 7000 | Belgium |
|
| Hôpital Mont-Godinne | Not yet recruiting | Yvoir | 5530 | Belgium |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D056831 |
| Coordination Complexes |
| D009930 | Organic Chemicals |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |