Carcinoma, Non-Small-Cell LungPACT-01NCT04823377
Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
A study testing Optimization of the medical decision in people with Carcinoma, Non-Small-Cell Lung and Advanced Cancer, run by Institut Curie at 25 sites in France.
Trial summary
Sequential comparative prospective interventional study evaluating the impact of the use of an optimization device of the decision of cancer treatment on aggressiveness of end of life care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Advanced Cancer
- What is being tested?
- Optimization of the medical decision
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 364 participants
- Where
- 25 sitesFrance
- Study dates
- 24 Sep 2021to 23 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Histologically or cytologically proven non-small-cell lung carcinoma (NSCLC) including NSCLC with oncogene addiction.
- Stage IV or IIB/IIIC non irradiable (8th classification TNM, UICC 2015)
- Patient having completed at least one line of chemotherapy in the context of metastatic disease (or in the context of locoregional disease if the last chemotherapy was less than 6 months ago).
- ECOG Performance Status ≥ 2.
- Age ≥ 18.
- Written informed consent.
- Patient capable, according to the investigator, to comply with the requirements of the study.
Who cannot join
- Small Cell Lung Cancer (including mixed forms).
- Patient with NSCLC for whom a decision has already been made to permanently discontinue all systemic cancer treatment.
- Impossible follow up for geographical, social or psychological reason.
- Inability to answer a questionnaire (language or neurological barrier).
- Patient under guardianship.
- Patient being treated in a therapeutic trial.
- Patient not covered by social security. -
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
France25 sites
CH Abbeville
Abbeville, 80142
CH du Pays d'Aix
Aix-en-Provence, 13616
CHU Amiens - Hôpital Sud
Amiens, 80054
CHU Angers
Angers, 49933
CHR Metz-Thionville - Hôpital de Mercy
Ars-Laquenexy
CH Henri Duffaut Avignon
Avignon, 84000
Institut Sainte-Catherine
Avignon, 84918
AP-HP Ambroise Paré
Boulogne-Billancourt, 92100
CHI de Compiègne-Noyon
Compiègne, 60200
CHU Sud Francilien
Corbeil-Essonnes, 91100
Clinique des Cèdres
Cornebarrieu, 31700
CH Intercommunal de Créteil
Créteil, 94000
CGFL
Dijon, 21000
CHU Grenoble Alpes
Grenoble, 38043
CHD Vendée
La Roche-sur-Yon, 85925
CHRU Lille
Lille, 59000
Centre Léon Bérard
Lyon, 69008
Institut Curie
Paris, 75005
AP-HP Cochin
Paris, 75014
AP-HP Bichat
Paris, 75018
AP-HP Tenon
Paris, 75970
Institut Curie
Saint-Cloud, 92210
CH Saint-Malo
St-Malo, 35420
Hôpital Foch
Suresnes, 92150
Clinique Tessier
Valenciennes, 59300
About this study
Sequential comparative prospective interventional study evaluating the impact of the use of an optimization device of the decision of cancer treatment on aggressiveness of end of life care. Comparison between a first period, period (A), of care as usual and a second period, period (B), of systematic and iterative use of a device for optimizing the decision to continue an anti-cancer treatment.
Read the detailed description
We propose to study the optimization of this decision process in an advanced Non-Small-Cell Lung Carcinoma (NSCLC) population, with a Performance Status (PS) ≥ 2 (median survival of approximately 3 months) piloting iteratively (before each decision to continue treatment) a process consisting of an evaluation framework (30 items to be answered by the oncologist with the patient), consolidating:
- clinical parameters;
- doctors' expectations regarding the continuation of anticancer treatment;
- patient expectations and preferences;
- the possibility of referring the patient to a supportive care specialist and strengthening home care.
The process triggers a dialogue between the patient and the oncologist, based on facts and seeks objectivity, ultimately allowing a shared decision.
In this prospective comparative study, the rate of systemic oncological treatment during the last month of life will be measured consecutively, over a period of usual management, followed by a period of systematic application of a process of optimization of the medical decision.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Advanced Cancer
- Being tested
- Usual care, Optimization of the medical decision
- Keywords
- cancer therapy, last days of life, optimization device
- 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.
Usual careOther
Patients receiving systemic anticancer treatment in their last days of life
Optimization of the medical decisionOther
Impact of the use of an optimization device of the decision of cancer treatment on aggressiveness of end of life care
| Study group | Role | What they receive |
|---|---|---|
| Period A: Usual management | Other | Period of end-of-life care as usual Receives: Other: Usual care |
| Period B: Process of optimization of the medical decision | Other | Period of systematic and iterative use of a device for optimizing the decision to continue an anti-cancer treatment. Receives: Other: Optimization of the medical decision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients receiving systemic anticancer treatment in their last days of life
Comparison of the percentage of patients receiving systemic anticancer treatment in their last 30 days of life during each period
Measured: 24 months
Secondary outcomes (8)
Percentage of chemotherapy
Percentage of chemotherapy (IV, oral) administered in the last 60, 30 and 14 days of life,
Measured: 24 months
Number of emergency room visits
Percentage of patients visiting emergency room visits more than once and of unplanned hospitalizations and intensive care admission in the last month of life.
Measured: 24 months
Percentage of initiation of a new line of chemotherapy
Percentage of initiation of a new line of chemotherapy (IV, oral) in the last month of life
Measured: 24 months
Percentage of immunotherapy and of Tyrosine kinase inhibitor
Percentage of immunotherapy and of Tyrosine kinase inhibitor in the last 60, 30 and 14 days of life.
Measured: 24 months
Percentage of initiation of Tyrosine kinase inhibitor or immunotherapy
Percentage of initiation of Tyrosine kinase inhibitor or immunotherapy in the last month of life.
Measured: 24 months
Use of supportive care
Frequency and precocity of use of supportive care.
Measured: 24 months
Overall survival (OS)
Overall survival (OS) defined as the time from the date of consent to the date of death due to any cause.
Measured: 24 months
Quality of life using QLQ-C15-PAL EORTC (European Organization for Research and Treatment of Cancer) and anxiety with HAD (Hospital Anxiety and Depression) questionnaire
The quality of Life in palliative cancer care patients will be collected with QLQ-C15-PAL EORTC scale and anxiety will be mesured with HAD scale.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start24 Sep 2021
- Primary completion23 Sep 2026 (estimated)
- Study completion23 Sep 2027 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- In this prospective comparative study, the rate of systemic oncological treatment during the last month of life will be measured consecutively, over a period of usual management, followed by a period of systematic application of a process of optimization of the medical decision.
- Masking
- None (open label)
- Enrolment
- 364 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Ange MASSIANI, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823377
- Sponsor's protocol ID
- IC 2020-05
- Acronym
- PACT-01
- Status last verified
- Nov 2025
- First submitted
- 29 Mar 2021
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT04823377
- Acronym / sponsor ID
- PACT-01 / IC 2020-05
- Conditions
- Carcinoma, Non-Small-Cell Lung, Advanced Cancer
- Keywords
- cancer therapy, last days of life, optimization device
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 364 participants (estimated)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 23 Sep 2026 (estimated)
- Study completion
- 23 Sep 2027 (estimated)
- First posted
- 30 Mar 2021 (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.
Sequential comparative prospective interventional study evaluating the impact of the use of an optimization device of the decision of cancer treatment on aggressiveness of end of life care. Comparison between a first period, period (A), of care as usual and a second period, period (B), of systematic and iterative use of a device for optimizing the decision to continue an anti-cancer treatment.
Detailed description
We propose to study the optimization of this decision process in an advanced Non-Small-Cell Lung Carcinoma (NSCLC) population, with a Performance Status (PS) ≥ 2 (median survival of approximately 3 months) piloting iteratively (before each decision to continue treatment) a process consisting of an evaluation framework (30 items to be answered by the oncologist with the patient), consolidating:
- clinical parameters;
- doctors' expectations regarding the continuation of anticancer treatment;
- patient expectations and preferences;
- the possibility of referring the patient to a supportive care specialist and strengthening home care.
The process triggers a dialogue between the patient and the oncologist, based on facts and seeks objectivity, ultimately allowing a shared decision.
In this prospective comparative study, the rate of systemic oncological treatment during the last month of life will be measured consecutively, over a period of usual management, followed by a period of systematic application of a process of optimization of the medical decision.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this prospective comparative study, the rate of systemic oncological treatment during the last month of life will be measured consecutively, over a period of usual management, followed by a period of systematic application of a process of optimization of the medical decision.
| Arm | Type | Receives |
|---|---|---|
| Period A: Usual management | Other | Other: Usual carePeriod of end-of-life care as usual |
| Period B: Process of optimization of the medical decision | Other | Other: Optimization of the medical decisionPeriod of systematic and iterative use of a device for optimizing the decision to continue an anti-cancer treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically proven non-small-cell lung carcinoma (NSCLC) including NSCLC with oncogene addiction.
- Stage IV or IIB/IIIC non irradiable (8th classification TNM, UICC 2015)
- Patient having completed at least one line of chemotherapy in the context of metastatic disease (or in the context of locoregional disease if the last chemotherapy was less than 6 months ago).
- ECOG Performance Status ≥ 2.
- Age ≥ 18.
Key exclusion criteria (7 listed)
- Small Cell Lung Cancer (including mixed forms).
- Patient with NSCLC for whom a decision has already been made to permanently discontinue all systemic cancer treatment.
- Impossible follow up for geographical, social or psychological reason.
- Inability to answer a questionnaire (language or neurological barrier).
- Patient under guardianship.
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 |
|---|---|---|
| Usual carePatients receiving systemic anticancer treatment in their last days of life | Other | Period A: Usual management |
| Optimization of the medical decisionImpact of the use of an optimization device of the decision of cancer treatment on aggressiveness of end of life care | Other | Period B: Process of optimization of the medical decision |
Primary outcome
Percentage of patients receiving systemic anticancer treatment in their last days of life
Time frame: 24 months
Comparison of the percentage of patients receiving systemic anticancer treatment in their last 30 days of life during each period
8 secondary outcomes
Percentage of chemotherapy
Time frame: 24 months
Number of emergency room visits
Time frame: 24 months
Percentage of initiation of a new line of chemotherapy
Time frame: 24 months
Percentage of immunotherapy and of Tyrosine kinase inhibitor
Time frame: 24 months
Percentage of initiation of Tyrosine kinase inhibitor or immunotherapy
Time frame: 24 months
Use of supportive care
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months
Quality of life using QLQ-C15-PAL EORTC (European Organization for Research and Treatment of Cancer) and anxiety with HAD (Hospital Anxiety and Depression) questionnaire
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Related trials for Carcinoma, Non-Small-Cell Lung
RecruitingPhase 1/2
A Study to Investigate ALE.P02 as a Monotherapy or in Combination With Pembrolizumab in Adult Patients With Selected CLDN1+ Solid Tumors
Squamous Non-small-cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 3
A Clinical Study to Assess the Efficacy of Adjuvant Immunotherapy With Cemiplimab in Patients With Surgically Removed Non-small Cell Lung Cancer Who Have Not Received Prior Chemotherapy
Non-Small Cell Lung Cancer
RecruitingPhase 2
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
Advanced Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma
Not yet recruitingPhase 2/3
Master Protocol for the Study of Rilogrotug for the Treatment of Weight Loss and Anorexia in Patients With Cancer Cachexia and mCRC or mNSCLC
Cachexia; Cancer, Cachexia
RecruitingPhase 3
Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial
Lung Non-Small Cell Carcinoma
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.
Marie-Ange MASSIANI, MD principal investigator
Institut Curie
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimization of the medical decision in people with Carcinoma, Non-Small-Cell Lung and Advanced Cancer, run by Institut Curie at 25 sites in France.
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 7 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients receiving systemic anticancer treatment in their last days of life (time frame: 24 months). 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 28 Nov 2025.