Immunotherapy in Lung Cancer: Treatment After IO Cessation.

NCT04465942 | Unknown

• 1 other identifier: 01171
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 5

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.

Conditions

Carcinoma, Non-Small-Cell Lung; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• survival

  From IO cessation date up to death or up to 5 years

• 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

• Disease-free survival

  From IO cessation to progression documentation or death or up to 5 years

• second-line ICI effectiveness - response

  From initiation of second-line IO up to 2 years

• second-line ICI effectiveness - progression-free survival

  From initation of second-line ICI up to progression or death and up to 5 years

Interventions

(chemo)immunotherapy DRUG

Patients are receiving immunotherapy or chemoimmunotherapy as a standard of care

Also known as: cisplatinum, carboplatinum, pemetrexed, paclitaxel, pembrolizumab, nivolumab, atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stage IV or unresectable and non irradiable NSCLC, naïve of immunotherapy and receiving immunotherapy alone or combined chemo-immunotherapy

You may qualify if:

• 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.

You may not qualify if:

• Patients receiving adjuvant immunotherapy for stage I-III NSCLC are not eligible
• 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

Sponsors & Collaborators

• European Lung Cancer Working Party: lead

Study Sites (5)

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet

Brussels, 1000, Belgium

RECRUITING

Department of Pneumology CHU Charleroi

Charleroi, 6000, Belgium

NOT YET RECRUITING

Department of Pneumology Hôpital Saint-Joseph

Gilly, 6060, Belgium

NOT YET RECRUITING

Hôpital Ambroise Paré

Mons, 7000, Belgium

NOT YET RECRUITING

Hôpital Mont-Godinne

Yvoir, 5530, Belgium

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Carboplatin; Pemetrexed; Paclitaxel; pembrolizumab; Nivolumab; atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Thierry Berghmans, MD, PhD

  ELCWP

  STUDY CHAIR

Central Study Contacts

Thierry Berghmans, MD, PhD

CONTACT

003225413191; thierry.berghmans@bordet.be

Bogdan Grigoriu, MD, PhD

CONTACT

003225413191; bogdan.grigoriu@bordet.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 10, 2020
• Study Start: June 26, 2020
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: August 23, 2021

Record last verified: 2021-08

Locations

BE (5)