Immunotherapy in Lung Cancer: Treatment After IO Cessation.

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

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.

Study Overview

• Status: Recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung; Immunotherapy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Thierry Berghmans, MD, PhD; Phone Number: 003225413191; Email: thierry.berghmans@bordet.be
• Study Contact Backup: Name: Bogdan Grigoriu, MD, PhD; Phone Number: 003225413191; Email: bogdan.grigoriu@bordet.be

Study Locations

• Belgium
  • Brussels, Belgium, 1000
    • Recruiting
    • Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
    • Contact: Thierry Berghmans, MD, PhD; Phone Number: 0032/2/5413191
    • Principal Investigator: Thierry Berghmans, MD, PhD
  • Charleroi, Belgium, 6000
    • Not yet recruiting
    • Department of Pneumology CHU Charleroi
    • Contact: Ionela Bold, MD
    • Principal Investigator: Ionela Bold, MD
  • Gilly, Belgium, 6060
    • Not yet recruiting
    • Department of Pneumology Hôpital Saint-Joseph
  • Mons, Belgium, 7000
    • Not yet recruiting
    • Hopital Ambroise Pare
    • Sub-Investigator: Patricia Wackenier, MD
  • Yvoir, Belgium, 5530
    • Not yet recruiting
    • Hôpital Mont-Godinne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: European Lung Cancer Working Party

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 26, 2020
• Primary Completion (ANTICIPATED): June 1, 2024
• Study Completion (ANTICIPATED): June 1, 2025

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (ACTUAL): July 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Folic Acid Antagonists; Paclitaxel; Nivolumab; Pembrolizumab; Pemetrexed; Atezolizumab
• Other Study ID Numbers: 01171

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No