Immunotherapy in Lung Cancer: Treatment After IO Cessation.

Last updated: August 20, 2021
Sponsor: European Lung Cancer Working Party
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vaccines

Cancer Treatment

Chemotherapy

Treatment

N/A

Clinical Study ID

NCT04465942
01171
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histological diagnosis of non-small cell lung cancer (NSCLC)
  • Stage IVA/IVB and unresectable and non irradiable stage III NSCLC naïve ofimmunotherapy.
  • Patients who receive immunotherapy (any type) monotherapy, combined immunotherapy orin combination with chemotherapy for first or second-line treatment.
  • Availability for participating in the detailed follow-up of the protocol.
  • Signed informed consent.

Exclusion

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 situcarcinoma of the cervix or of the bladder or cured malignant tumor (more than 5-yeardisease free interval).
  • Any type of immunotherapy for previous cancer

Study Design

Total Participants: 300
Study Start date:
June 26, 2020
Estimated Completion Date:
June 30, 2025

Study 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).

Connect with a study center

  • Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet

    Brussels, 1000
    Belgium

    Active - Recruiting

  • Department of Pneumology CHU Charleroi

    Charleroi, 6000
    Belgium

    Site Not Available

  • Department of Pneumology Hôpital Saint-Joseph

    Gilly, 6060
    Belgium

    Site Not Available

  • Hôpital Ambroise Paré

    Mons, 7000
    Belgium

    Site Not Available

  • Hôpital Mont-Godinne

    Yvoir, 5530
    Belgium

    Site Not Available

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