Immunotherapy in Lung Cancer: Treatment After IO Cessation.

Sponsor

European Lung Cancer Working Party (Other)

Overall Status

Recruiting

CT.gov ID

NCT04465942

Collaborator

(none)

300

Enrollment

Locations

59.2

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung Immunotherapy	Drug: (chemo)immunotherapy

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).

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 26, 2020

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet	Brussels	Belgium	1000
2	Department of Pneumology CHU Charleroi	Charleroi	Belgium	6000
3	Department of Pneumology Hôpital Saint-Joseph	Gilly	Belgium	6060
4	Hôpital Ambroise Paré	Mons	Belgium	7000
5	Hôpital Mont-Godinne	Yvoir	Belgium	5530