Immunotherapy in Lung Cancer: Treatment After IO Cessation.

NCT ID: NCT04465942

Last Updated: 2021-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-26

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Carcinoma, Non-Small-Cell Lung Immunotherapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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(chemo)immunotherapy

Patients are receiving immunotherapy or chemoimmunotherapy as a standard of care

Intervention Type DRUG

Other Intervention Names

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cisplatinum carboplatinum pemetrexed paclitaxel pembrolizumab nivolumab atezolizumab

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Lung Cancer Working Party

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thierry Berghmans, MD, PhD

Role: STUDY_CHAIR

ELCWP

Locations

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Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet

Brussels, , Belgium

Site Status RECRUITING

Department of Pneumology CHU Charleroi

Charleroi, , Belgium

Site Status NOT_YET_RECRUITING

Department of Pneumology Hôpital Saint-Joseph

Gilly, , Belgium

Site Status NOT_YET_RECRUITING

Hôpital Ambroise Paré

Mons, , Belgium

Site Status NOT_YET_RECRUITING

Hôpital Mont-Godinne

Yvoir, , Belgium

Site Status NOT_YET_RECRUITING

Countries

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Belgium

Central Contacts

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Thierry Berghmans, MD, PhD

Role: CONTACT

003225413191

Bogdan Grigoriu, MD, PhD

Role: CONTACT

003225413191

Facility Contacts

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Thierry Berghmans, MD, PhD

Role: primary

0032/2/5413191

Ionela Bold, MD

Role: primary

Benoît Colinet, MD

Role: primary

Stéphane Holbrechts, MD

Role: primary

Sebahat Ocak, MD, PhD

Role: primary

Other Identifiers

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01171

Identifier Type: -

Identifier Source: org_study_id

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