Carcinoma, Non-Small-Cell LungNCT04465942
Immunotherapy in Lung Cancer: Treatment After IO Cessation.
An observational study of Carcinoma, Non-Small-Cell Lung and Immunotherapy, run by European Lung Cancer Working Party at 5 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Immunotherapy
- What is being tested?
- (chemo)immunotherapy
- How many people
- 300 participants
- Where
- 5 sitesBelgium
- Study dates
- 26 Jun 2020to Jun 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stage IV or unresectable and non irradiable NSCLC, naïve of immunotherapy and receiving immunotherapy alone or combined chemo-immunotherapy
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Belgium5 sites, 5 recruiting
- Recruiting
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, 1000
Thierry Berghmans, MD, PhD, 0032/2/5413191
Thierry Berghmans, MD, PhD
- Not yet recruiting
Department of Pneumology CHU Charleroi
Charleroi, 6000
Ionela Bold, MD
Ionela Bold, MD
- Not yet recruiting
Department of Pneumology Hôpital Saint-Joseph
Gilly, 6060
Benoît Colinet, MD
Benoît Colinet, MD
- Not yet recruiting
Hôpital Ambroise Paré
Mons, 7000
Stéphane Holbrechts, MD
Patricia Wackenier, MD
- Not yet recruiting
Hôpital Mont-Godinne
Yvoir, 5530
Sebahat Ocak, MD, PhD
Sebahat Ocak, MD, PhD
About this study
Official title: 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.
Read the 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).
- Conditions
- Carcinoma, Non-Small-Cell Lung, Immunotherapy
- Being tested
- (chemo)immunotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(chemo)immunotherapyDrug
Also called cisplatinum, carboplatinum, pemetrexed, paclitaxel
Patients are receiving immunotherapy or chemoimmunotherapy as a standard of care
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine the therapeutic landscape after cessation of an immune checkpoint therapy
Which treatment is proposed after IO cessation
Measured: From IO cessation date up to first treatment whatever the time in-between and up to 5 years
Secondary outcomes (7)
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])
Measured: 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
Measured: 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
Measured: 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
Measured: From initiation of second-line IO up to 2 years
second-line ICI effectiveness - progression-free survival
PFS to second-line ICI
Measured: 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
Measured: 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
Measured: From initation of second-line ICI up to death and up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start26 Jun 2020
- Primary completionJun 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- European Lung Cancer Working Party
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Berghmans, MD, PhD, Study chair, ELCWP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465942
- Sponsor's protocol ID
- 01171
- Status last verified
- Aug 2021
- First submitted
- 25 Jun 2020
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy in Lung Cancer: Which Treatment After Immunotherapy Cessation: A Prospective Registry From the European Lung Cancer Working Party
- ClinicalTrials.gov ID
- NCT04465942
- Acronym / sponsor ID
- 01171
- Conditions
- Carcinoma, Non-Small-Cell Lung, Immunotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- European Lung Cancer Working PartyUniversity, hospital or other
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stage IV or unresectable and non irradiable NSCLC, naïve of immunotherapy and receiving immunotherapy alone or combined chemo-immunotherapy
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (chemo)immunotherapyAlso: cisplatinum, carboplatinum, pemetrexed, paclitaxelPatients are receiving immunotherapy or chemoimmunotherapy as a standard of care | Drug | – |
Primary outcome
to determine the therapeutic landscape after cessation of an immune checkpoint therapy
Time frame: From IO cessation date up to first treatment whatever the time in-between and up to 5 years
Which treatment is proposed after IO cessation
7 secondary outcomes
survival
Time frame: From IO cessation date up to death or up to 5 years
Activity of salvage therapy - response
Time frame: 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
Time frame: From IO cessation to progression documentation or death or up to 5 years
second-line ICI effectiveness - response
Time frame: From initiation of second-line IO up to 2 years
second-line ICI effectiveness - progression-free survival
Time frame: From initation of second-line ICI up to progression or death and up to 5 years
Activity of salvage therapy - progression-free survival
Time frame: From initation of salvage therapy up to progression or death and up to 5 years
Activity of salvage therapy - survival
Time frame: From initation of second-line ICI up to death and up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry Berghmans, MD, PhD study chair
ELCWP
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung and Immunotherapy, run by European Lung Cancer Working Party at 5 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thierry Berghmans, MD, PhD (003225413191, thierry.berghmans@bordet.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to determine the therapeutic landscape after cessation of an immune checkpoint therapy (time frame: From IO cessation date up to first treatment whatever the time in-between and up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.