Immunotherapy in Lung Cancer: Treatment After IO Cessation.

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04465942
• Other study ID #: 01171
• Status: Recruiting
• Start date: June 26, 2020
• Est. completion date: June 2025

Study information

• Verified date: August 2021
• Source: European Lung Cancer Working Party
• Contact: Thierry Berghmans, MD, PhD
• Phone: 003225413191
• Email: thierry.berghmans[@]bordet.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Immunotherapy

Intervention

Drug:
• (chemo)immunotherapy
Patients are receiving immunotherapy or chemoimmunotherapy as a standard of care

Locations

Country	Name	City	State
Belgium	Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet	Brussels
Belgium	Department of Pneumology CHU Charleroi	Charleroi
Belgium	Department of Pneumology Hôpital Saint-Joseph	Gilly
Belgium	Hôpital Ambroise Paré	Mons
Belgium	Hôpital Mont-Godinne	Yvoir

Sponsors (1)

Lead Sponsor	Collaborator
European Lung Cancer Working Party

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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