Immunotherapy in Lung Cancer: Treatment After IO Cessation.

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Immunotherapy in Lung Cancer: Which Treatment After Immunotherapy Cessation: A Prospective Registry From the European Lung Cancer Working Party

Conditions
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Carcinoma, Non-Small-Cell Lung, Immunotherapy

Intervention / Treatment
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* Drug: (chemo)immunotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: (chemo)immunotherapy|Patients are receiving immunotherapy or chemoimmunotherapy as a standard of care|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |