CacheMire: Non-interventional Study to Assess the Frequency of Cachexia in Patients With Non-small Cell Lung Cancer.

• Sponsor: Chugai Pharma France (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02968979
• Collaborator: French College of General Hospital Pneumologists (CPHG) (Other), French-Speaking Association of Supportive Care in Cancer (AFSOS) (Other), ITEC Services (Other)
• Enrollment: 539
• Location: 1
• Duration (Months): 3
• Patients Per Site Per Month: 178.3

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the frequency of cachexia and the management of cachexia and associated symptoms in a patient population with non-small cell lung cancer (NSCLC).

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer; Cachexia

Detailed Description

This is a cross-sectional, non-interventional, European (France and Belgium), multicentric prevalence study, conducted on a representative population of 500 patients with NSCLC, to assess the frequency and the management of cachexia and associated symptoms.

The study will be conducted in accordance with the professional code of ethics and the good epidemiological practices guidelines developed by the ADELF (the Association of French-Speaking Epidemiologists) and in accordance with the STROBE recommendations for the drafting of reports and publications related to the study.

The information will be collected during a single visit to the oncologist/lung specialist as part of the usual patient management of his/her lung cancer. The physician will explain the purpose of the study to the patient with an information form specific to the study and will inform him/her of the option to refuse or withdraw from participation. The patient information form in France or a specific consent form in Belgium will be signed by the patient and a copy will be given to him/her (the original will be kept by the physician).

This study does not require any additional specific data. Data will come from the medical file and from the routine disease management. Furthermore, the following self-completion questionnaires will be proposed to patients: Visual analogue scale for dietary intake (dietary intake VAS), assessment of the concerns associated with the anorexia/cachexia (Anorexia-Cachexia module of the Functional Assessment of Anorexia/Cachexia Therapy [FAACT] questionnaire), quality of life (EORTC QLQ-C30), and assessment of physical activity (IPAQ, International Physical Activity Questionnaire). Abdominal CT-scan, if available, will be collected for assessment of skeletal muscle mass index at L3.

Study Design

• Study Type: Observational
• Actual Enrollment: 539 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Cross-sectional, Multicentric, Non-interventional Study to Assess the Frequency and the Management of Cachexia and Associated Symptoms in Patients With Non-small Cell Lung Cancer.
• Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Outcome Measures

Primary Outcome Measures

1. Frequency of Cachexia According to Modified Fearon Criteria [Day1]

   Percentage of NSCLC patients with a cachexia according to Fearon criteria modified for the stages of pre-cachexia and refractory cachexia in order to classify all the featured cases without ambiguity. A patient was considered to have cachexia if he/she had: Weight loss >5% in the last 6 months prior to inclusion or BMI <20 kg/m² and weight loss between 2 and 5% in the 6 months prior to inclusion or Weight loss >2% and sarcopenia (as evaluated by the muscle mass index at L3) if available. If data were not available regarding possible sarcopenia, the presence of cachexia was assigned based on the 2 above conditions. In the 3 cases defined above, patient should not have entered the refractory cachexia stage, which was defined as: ECOG performance score of 3 or 4 and a low survival expectancy as defined by Martin et al. (J Clin Oncol 2015) (BMI <20 kg/m² and weight loss ≥ 6%) or (20 ≤ BMI ≤ 21.9 kg/m² and weight loss ≥ 11%) or (22 kg/m² ≤ BMI and weight loss ≥ 15%).

Secondary Outcome Measures

1. Frequency of the Different Stages of Cachexia in the General NSCLC Population [Day 1]

   Percentage of the different stages of cachexia at inclusion. The different stages of cachexia used the following classification: No Cachexia: 1) no weight loss (WL<2%) or 2) weight gain AND no anorexia AND no sarcopenia The pre-cachexia stage : 1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss < 2% AND sarcopenia Cachexia: 1) Weight loss > 5% OR 2) weight loss between 2 and 5% AND BMI < 20 kg/m² OR 3) weight loss > 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage Refractory cachexia: ECOG 3 or 4 AND low survival expectancy [BMI < 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]

2. Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Stage Associated With NSCLC. [Day 1]

   Percentage of the different stages of cachexia at inclusion according to the NSCLC stage

3. Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Histology Associated With NSCLC. [Day 1]

   Percentage of the different stages of cachexia according to the NSCLC histology

4. Frequency of Sarcopenia in the General NSCLC Patients With Cachexia [Day 1]

   Percentage of patients with sarcopenia in the general NSCLC patients with cachexia

5. Frequency of Sarcopenia With no Clinical Significant Weight Loss in the General NSCLC Patients With Pre-cachexia [Day 1]

   Percentage of patient with sarcopenia and no clinical significant weight loss (sarcopenia and WL< 2%) in the general NSCLC patients with pre-cachexia:

6. Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC. [Day 1]

   Percentage of the different stages of cachexia according to the molecular abnormalities associated with NSCLC: EGRF, ALK, ROS1, BRAF or HER2 K-RAS No mutation

7. Frequency of the Different Stages of Cachexia According to the Number of Treatments Received. [Day 1]

   NSCLC patients. 84 patients with missing data

8. Frequency of the Different Stages of Cachexia According to the Types of Treatments Received. [Day 1]

   Stage of cachexia at inclusion according to the type of treatments received (surgery, radiotherapy, chemotherapy, targeted therapies).

9. Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Nutritional State [Day 1]

   • Nutritional state according to the different stages of cachexia The variables used will be: serum albumin levels, serum pre-albumin levels, BMI and weight.

10. Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Blood Glucose [Day 1]

    Blood glucose abnormalities according to the different stages of cachexia at inclusion

11. Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - Dietary Intake Visual Analog Scale [Day 1]

    Dietary Intake Visual Analog Scale (Dietary intake VAS): The question "Could you indicate the amount you currently eat, placing a vertical mark on the line between "nothing at all" and "as usual"? ". Depending on the location of the patient mark on the scale, a score of between 0 ("nothing at all") and 10 ("as usual") will be allocated.

12. Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - AC/S FAACT [Day 1]

    Score of the 12-question AC/S module (Anorexia-Cachexia module) of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire assessing anorexia and cachexia: the AC/S module of the FAACT questionnaire consists of 12 questions to assess over the last 7 days quality of life, related to anorexia or cachexia. The score ranges between 0 and 48, the higher the score, the higher the quality of life.

13. Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Neutrophil/Lymphocyte Ratio [Day 1]

    neutrophil/lymphocyte ratio

14. Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - CRP [Day 1]

    CRP level

15. Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Fibrinogen [Day 1]

    fibrinogen level

16. Description of the Quality of Life Associated With the Different Stages of Cachexia. [Day 1]

    Quality of life has been analysed using scores from the functional scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 items (EORTC QLQ-C30 questionnaire): score ranging from 0 (malfunction) to 100 (healthy level of functioning) for the following parameters : physical, role, cognitive, emotional and social scales

17. Description of the Level of Physical Activity Associated With the Different Stages of Cachexia. [Day 1]

    Three levels of physical activity are defined: - Low No activity is reported OR An activity is reported but does not reach moderate or high levels. - Moderate Corresponds to one of the following 3 criteria: 3 or more days of intense activity lasting at least 20 min per day OR 5 or more days of moderate intensity activity and / or walking for at least 30 min per day OR 5 or more days of activity combining walking, activities of moderate or high intensity, thus achieving at least 600 MET-minutes / week - High Corresponds to one of the following 2 criteria: Intense activity at least 3 days a week and at least 1500 MET-minutes / week OR 7 or more days of activity combining walking, moderate and high intensity activities, achieving at least 3000 MET-minutes / week

18. Number of Participants Receiving a Pharmacological Treatment for Cachexia or for Associated Symptoms [Day 1]

    Pharmacological treatment of cachexia or associated symptoms: Yes / No

19. Number of Participants Receiving a Non-Pharmacological Treatment for Cachexia or for Associated Symptoms [Day 1]

    Non-pharmacological treatment of cachexia or associated symptoms: Y/N

20. Number of Participants Receiving Systemic Corticosteroids, Anti-inflammatory Drugs, Omega 3 Fatty Acids Treatments [Day 1]

    Treatments with systemic corticosteroids, anti-inflammatory drugs, Omega 3 fatty acids: Yes/No

21. Number of Participants With Diabetes Treatments [Day 1]

    Diabetes treatments : Yes/No

22. Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Cachexia [Day 1]

    Proportion of patients with cachexia according to the subjective assessment of the clinician Proportion of patients with cachexia according to the Fearon criteria

23. Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Anorexia [Day 1]

    Proportion of patients with anorexia according to the subjective assessment of the clinician Proportion of patients with anorexia according to the Ingesta VAS Proportion of patients with anorexia according to the AC/S-FAACT module score Proportion of patients with anorexia according to question 13 of the QLQ-C30 questionnaire: "Have you had a lack of appetite?"

24. Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Malnutrition [Day 1]

    Proportion of patients with severe malnutrition according to the subjective assessment of the clinician Proportion of patients with severe malnutrition according to the malnutrition criteria defined by the HAS.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient 18 years of age and older

• Patient with NSCLC

• Patient who has been informed of the study and who has signed a patient information leaflet for France or an informed consent for Belgium

• Patient able to complete a self-assessment questionnaire

Exclusion Criteria:

• Patient unable to consent and/or unable to sign the patient information form in France or an informed consent in Belgium

• Patient with a complete resection of an early stage NSCLC

• History of head and neck cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chugai Pharma France	Paris		France	92042

Sponsors and Collaborators

• Chugai Pharma France
• French College of General Hospital Pneumologists (CPHG)
• French-Speaking Association of Supportive Care in Cancer (AFSOS)
• ITEC Services

Investigators

• Study Director: Luz Bobadilla, MD, Chugai Pharma France

Study Documents (Full-Text)

None provided.

More Information

Publications

• Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4. Review.

• Responsible Party: Chugai Pharma France
• ClinicalTrials.gov Identifier: NCT02968979
• Other Study ID Numbers: CPF-ANA-001
• First Posted: Nov 21, 2016
• Last Update Posted: Sep 24, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Chugai Pharma France: Cachexia; Non-Small Cell Lung cancer; Anorexia; Malnutrition
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Wasting Syndrome; Cachexia

Study Results

Participant Flow

Recruitment Details	56 oncologists, lung specialists or radiation oncologists treating patients with a malignant lung tumour have recruited patients from outpatient visit, day hospital or in-patient hospitalization in France and Belgium, between the 25th of July and the 31th of October 2016. Patients were recruited in a consecutive manner.
Pre-assignment Detail	539 patients were recruited. Among them, 5 did not meet the eligibility criteria, 1 withdrew his/her consent, 2 were excluded during the data review because the cancer histology was undefined. The analysis population included 531 patients and among them 312 had skeletal muscle mass assessment.

Arm/Group Title	NSCLC Patient
Arm/Group Description	Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line
Period Title: Overall Study
STARTED	539
COMPLETED	531
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	NSCLC Patient
Arm/Group Description	Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line
Overall Participants	531
Age (year) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [year]	65.2 (10)
Sex: Female, Male (Count of Participants)
Female	178 33.5%
Male	353 66.5%
Performance Status ECOG (Eastern Cooperative Oncology Group) (Count of Participants)
0	124 23.4%
1	300 56.5%
2	87 16.4%
3	19 3.6%
4	1 0.2%
Smoking status (Count of Participants)
Non smoker	64 12.1%
Past smoker	359 67.6%
Current smoker	97 18.3%
Missing	11 2.1%
Histology type (Count of Participants)
Squamous cell carcinoma	140 26.4%
Adenocarcinoma	348 65.5%
Large cell carcinoma	18 3.4%
Others	25 4.7%
Molecular abnormalities (Count of Participants)
EGFR, ALK, ROS1, BRAF or HER2	54 10.2%
K-RAS	61 11.5%
None	214 40.3%
Tumor stages (Count of Participants)
Stage I-II	34 6.4%
Stage IIIA	21 4%
Stage IIIB-IV	440 82.9%
Unknown stage	9 1.7%

Outcome Measures

1. Primary Outcome

Title	Frequency of Cachexia According to Modified Fearon Criteria
Description	Percentage of NSCLC patients with a cachexia according to Fearon criteria modified for the stages of pre-cachexia and refractory cachexia in order to classify all the featured cases without ambiguity. A patient was considered to have cachexia if he/she had: Weight loss >5% in the last 6 months prior to inclusion or BMI <20 kg/m² and weight loss between 2 and 5% in the 6 months prior to inclusion or Weight loss >2% and sarcopenia (as evaluated by the muscle mass index at L3) if available. If data were not available regarding possible sarcopenia, the presence of cachexia was assigned based on the 2 above conditions. In the 3 cases defined above, patient should not have entered the refractory cachexia stage, which was defined as: ECOG performance score of 3 or 4 and a low survival expectancy as defined by Martin et al. (J Clin Oncol 2015) (BMI <20 kg/m² and weight loss ≥ 6%) or (20 ≤ BMI ≤ 21.9 kg/m² and weight loss ≥ 11%) or (22 kg/m² ≤ BMI and weight loss ≥ 15%).
Time Frame	Day1

Outcome Measure Data

Analysis Population Description

missing data for 84 patients

Arm/Group Title	NSCLC Patients With Cachexia
Arm/Group Description	Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia
Measure Participants	447
Count of Participants [Participants]	173 32.6%

2. Secondary Outcome

Title	Frequency of the Different Stages of Cachexia in the General NSCLC Population
Description	Percentage of the different stages of cachexia at inclusion. The different stages of cachexia used the following classification: No Cachexia: 1) no weight loss (WL<2%) or 2) weight gain AND no anorexia AND no sarcopenia The pre-cachexia stage : 1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss < 2% AND sarcopenia Cachexia: 1) Weight loss > 5% OR 2) weight loss between 2 and 5% AND BMI < 20 kg/m² OR 3) weight loss > 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage Refractory cachexia: ECOG 3 or 4 AND low survival expectancy [BMI < 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Missing data for 84 patients

Arm/Group Title	NSCLC Patients
Arm/Group Description	Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line
Measure Participants	447
No Cachexia	119 22.4%
Pre-Cachexia	151 28.4%
Cachexia	173 32.6%
Refractory Cachexia	4 0.8%

3. Secondary Outcome

Title	Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Stage Associated With NSCLC.
Description	Percentage of the different stages of cachexia at inclusion according to the NSCLC stage
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) Missing data for 81 patients

Arm/Group Title	Cancer Stage I-II	Cancer Stage IIIA	Cancer Stage IIIB- IV
Arm/Group Description	Patients with one of the following TNMs at the time of the visit: (T1a /T1b N0 M0) (T2a N0 M0) (T1a/T1b N1 M0 - T2a N1 M0 - T2b N0 M0) (T2b N1 M0 - T3 N0 M0)	Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)	Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)
Measure Participants	31	13	370
No Cachexia	9 1.7%	3 NaN	95 NaN
Pre-Cachexia	10 1.9%	5 NaN	124 NaN
Cachexia	11 2.1%	5 NaN	148 NaN
Refractory Cachexia	1 0.2%	0 NaN	3 NaN

4. Secondary Outcome

Title	Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Histology Associated With NSCLC.
Description	Percentage of the different stages of cachexia according to the NSCLC histology
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) Missing data for 84 patients

Arm/Group Title	Squamous Cell Carcinoma	Adenocarcinoma	Large Cell Carcinoma and Other Histology Type
Arm/Group Description	Patients with squamous cell carcinoma	Patients with adenocarcinoma	Patients with large cell carcinoma and other histology type
Measure Participants	116	296	35
No Cachexia	35 6.6%	79 NaN	5 NaN
Pre-Cachexia	38 7.2%	98 NaN	15 NaN
Cachexia	43 8.1%	115 NaN	15 NaN
Refractory Cachexia	0 0%	4 NaN	0 NaN

5. Secondary Outcome

Title	Frequency of Sarcopenia in the General NSCLC Patients With Cachexia
Description	Percentage of patients with sarcopenia in the general NSCLC patients with cachexia
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Population with no missing data for the 3 interest criteria defining the cachexia

Arm/Group Title	Cachexia NSCLC Patients
Arm/Group Description	A patient was considered to have cachexia if he/she had: Weight loss >5% in the last 6 months prior to inclusion or BMI <20 kg/m² and weight loss between 2 and 5% in the 6 months prior to inclusion or Weight loss >2% and sarcopenia (as evaluated by the muscle mass index at L3) if available. If data were not available regarding possible sarcopenia, the presence of cachexia was assigned based on the 2 above conditions. In the 3 cases defined above, patient should not have entered the refractory cachexia stage, which was defined as: ECOG performance score of 3 or 4 and a low survival expectancy as defined by Martin et al. (J Clin Oncol 2015) (BMI <20 kg/m² and weight loss ≥ 6%) or (20 ≤ BMI ≤ 21.9 kg/m² and weight loss ≥ 11%) or (22 kg/m² ≤ BMI and weight loss ≥ 15%).
Measure Participants	111
Count of Participants [Participants]	74 13.9%

6. Secondary Outcome

Title	Frequency of Sarcopenia With no Clinical Significant Weight Loss in the General NSCLC Patients With Pre-cachexia
Description	Percentage of patient with sarcopenia and no clinical significant weight loss (sarcopenia and WL< 2%) in the general NSCLC patients with pre-cachexia:
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Population with no missing data for the 3 interest criteria defining the pre-cachexia

Arm/Group Title	Pre-Cachexia NSCLC Patients
Arm/Group Description	Pre-cachexia was defined as: 2% ≤ weight loss (WL) ≤ 5% and BMI ≥ 20 kg/m² or anorexia or sarcopenia and WL< 2%
Measure Participants	89
Count of Participants [Participants]	59 11.1%

7. Secondary Outcome

Title	Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC.
Description	Percentage of the different stages of cachexia according to the molecular abnormalities associated with NSCLC: EGRF, ALK, ROS1, BRAF or HER2 K-RAS No mutation
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

NSCLC patients Overall number of patients analyzed for cachexia stage; 244 missing data.

Arm/Group Title	EGFR, ALK, ROS1, BRAF or HER2	K-RAS	No Mutation
Arm/Group Description	NSCLC patients with at least one of the following molecular abnormalities : EGFR, ALK, ROS1, BRAF or HER2	NSCLC patients with a K-RAS molecular abnormality	NSCLC patients with no mutation
Measure Participants	46	58	183
No Cachexia	8 1.5%	21 NaN	48 NaN
Pre-Cachexia	27 5.1%	13 NaN	54 NaN
Cachexia	11 2.1%	24 NaN	79 NaN
Refractory Cachexia	0 0%	0 NaN	2 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NSCLC Patients With Cachexia, Cancer Stage IIIA, Cancer Stage IIIB- IV
	Comments	Statistical analysis applies to all rows and columns.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0032
	Comments
	Method	likelihood-ratio test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	NSCLC Patients With Cachexia, Cancer Stage IIIA, Cancer Stage IIIB- IV
	Comments	Statistical Analysis 2 for Frequency of the Different Stages of Cachexia, excluding the refractory cachexia stage, in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC. Statistical analysis applies to all rows and columns.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0008
	Comments
	Method	Chi-squared
	Comments

8. Secondary Outcome

Title	Frequency of the Different Stages of Cachexia According to the Number of Treatments Received.
Description	NSCLC patients. 84 patients with missing data
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	no NSCLC Treatment	1 NSCLC Treatment	2 NSCLC Treatments	3 NSCLC Treatments	at Least 4 NSCLC Treatments
Arm/Group Description	Patient with no cancer treatment received for NSCLC	Patient with 1 cancer treatment received for NSCLC	Patient with 2 cancer treatments received for NSCLC	Patient with 3 cancer treatments received for NSCLC	Patient with at least 4 cancer treatments received for NSCLC
Measure Participants	41	82	137	79	107
No Cachexia	6 1.1%	18 NaN	42 NaN	26 NaN	27 NaN
Pre-Cachexia	11 2.1%	31 NaN	42 NaN	22 NaN	44 NaN
Cachexia	24 4.5%	32 NaN	50 NaN	31 NaN	36 NaN
Refractory Cachexia	0 0%	1 NaN	3 NaN	0 NaN	0 NaN

9. Secondary Outcome

Title	Frequency of the Different Stages of Cachexia According to the Types of Treatments Received.
Description	Stage of cachexia at inclusion according to the type of treatments received (surgery, radiotherapy, chemotherapy, targeted therapies).
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

NSCLC patients. 101 missing data

Arm/Group Title	Surgery	Radioterapy	Chemotherapy	Targeted Therapy
Arm/Group Description	Patient who had at least 1 surgery for NSCLC treatment	Patient who received at least 1 radiotherapy for NSCLC treatment	Patient who received at least 1 chemotherapy for NSCLC treatment	Patient with at least 1 targeted therapy received for NSCLC
Measure Participants	39	133	378	79
No Cachexia	7 1.3%	42 NaN	107 NaN	16 NaN
Pre-Cachexia	16 3%	50 NaN	121 NaN	42 NaN
Cachexia	16 3%	40 NaN	146 NaN	21 NaN
Refractory Cachexia	0 0%	1 NaN	4 NaN	0 NaN

10. Secondary Outcome

Title	Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Nutritional State
Description	• Nutritional state according to the different stages of cachexia The variables used will be: serum albumin levels, serum pre-albumin levels, BMI and weight.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

NSCLC patients

Arm/Group Title	Weight Loss >=15%	Weight Loss >=10%	Albuminemia < 30-35g/L	Pre-albuminemia < 110-200 mg/L	BMI <18.5-21 kg/m²
Arm/Group Description	Patients with weight loss at inclusion >=15% of the weight 6 months prior to inclusion.	Patients with weight loss at inclusion >=10% of the weight 6 months prior to inclusion.	Patients with albuminemia < 30g/L (patient < 70 years old) or < 35g/L (patient ≥ 70 years old)	Patients with pre-albuminemia < 110g/L (patient < 70 years old) or < 200 mg/L (patient ≥ 70 years old)	BMI at inclusion visit < 18,5 kg/m² (patient < 70 years old) or < 21 kg/m² (patients≥70 years old)
Measure Participants	31	63	35	6	68
No Cachexia	0 0%	0 NaN	5 NaN	2 NaN	8 NaN
Pre-Cachexia	0 0%	0 NaN	7 NaN	1 NaN	20 NaN
Cachexia	29 5.5%	60 NaN	21 NaN	3 NaN	37 NaN
Refractory Cachexia	2 0.4%	3 NaN	2 NaN	0 NaN	3 NaN

11. Secondary Outcome

Title	Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Blood Glucose
Description	Blood glucose abnormalities according to the different stages of cachexia at inclusion
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

NSCLC patients 329 data missing

Arm/Group Title	Normal Blood Glucose	Moderate Blood Glucose	High Blood Glucose
Arm/Group Description	< 1g/L	>= 1g/L <= 1.26g/L	>1.26g/L
Measure Participants	56	36	26
No cachexia	14 2.6%	5 NaN	4 NaN
Pre-cachexia	20 3.8%	15 NaN	12 NaN
Cachexia	21 4%	16 NaN	10 NaN
Refractory cachexia	1 0.2%	0 NaN	0 NaN

12. Secondary Outcome

Title	Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - Dietary Intake Visual Analog Scale
Description	Dietary Intake Visual Analog Scale (Dietary intake VAS): The question "Could you indicate the amount you currently eat, placing a vertical mark on the line between "nothing at all" and "as usual"? ". Depending on the location of the patient mark on the scale, a score of between 0 ("nothing at all") and 10 ("as usual") will be allocated.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

NSCLC patients 12 missing data

Arm/Group Title	No Cachexia	Pre-cachexia	Cachexia	Refractory Cachexia
Arm/Group Description	1) no weight loss (WL<2%) or 2) weight gain AND no anorexia AND no sarcopenia	1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss < 2% AND sarcopenia	1) Weight loss > 5% OR 2) weight loss between 2 and 5% AND BMI < 20 kg/m² OR 3) weight loss > 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage	ECOG 3 or 4 AND low survival expectancy [BMI < 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]
Measure Participants	117	146	168	4
Mean (Standard Deviation) [score on a scale]	9.57 (1.07)	7.68 (2.64)	6.51 (2.89)	3.13 (1.16)

13. Secondary Outcome

Title	Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - AC/S FAACT
Description	Score of the 12-question AC/S module (Anorexia-Cachexia module) of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire assessing anorexia and cachexia: the AC/S module of the FAACT questionnaire consists of 12 questions to assess over the last 7 days quality of life, related to anorexia or cachexia. The score ranges between 0 and 48, the higher the score, the higher the quality of life.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

NSCLC patients 9 missing data

Arm/Group Title	No Cachexia	Pre-cachexia	Cachexia	Refractory Cachexia
Arm/Group Description	1) no weight loss (WL<2%) or 2) weight gain AND no anorexia AND no sarcopenia	1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss < 2% AND sarcopenia	1) Weight loss > 5% OR 2) weight loss between 2 and 5% AND BMI < 20 kg/m² OR 3) weight loss > 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage	ECOG 3 or 4 AND low survival expectancy [BMI < 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]
Measure Participants	119	148	167	4
Mean (Standard Deviation) [score on a scale]	40.00 (3.90)	35.09 (7.02)	32.60 (7.16)	25.75 (10.05)

14. Secondary Outcome

Title	Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Neutrophil/Lymphocyte Ratio
Description	neutrophil/lymphocyte ratio
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

NSCLC patients 112 missing data

Arm/Group Title	No Cachexia	Pre-cachexia	Cachexia	Refractory Cachexia
Arm/Group Description	1) no weight loss (WL<2%) or 2) weight gain AND no anorexia AND no sarcopenia	1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss < 2% AND sarcopenia	1) Weight loss > 5% OR 2) weight loss between 2 and 5% AND BMI < 20 kg/m² OR 3) weight loss > 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage	ECOG 3 or 4 AND low survival expectancy [BMI < 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]
Measure Participants	86	113	132	4
Median (Inter-Quartile Range) [no unit (ratio)]	2.54	2.73	3.75	7.15

15. Secondary Outcome

Title	Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - CRP
Description	CRP level
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

NSCLC patients 317 missing data

Arm/Group Title	No Cachexia	Pre-cachexia	Cachexia	Refractory Cachexia
Arm/Group Description	1) no weight loss (WL<2%) or 2) weight gain AND no anorexia AND no sarcopenia	1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss < 2% AND sarcopenia	1) Weight loss > 5% OR 2) weight loss between 2 and 5% AND BMI < 20 kg/m² OR 3) weight loss > 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage	ECOG 3 or 4 AND low survival expectancy [BMI < 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]
Measure Participants	27	37	64	2
Median (Inter-Quartile Range) [mg/L]	18	7	21.5	16.5

16. Secondary Outcome

Title	Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Fibrinogen
Description	fibrinogen level
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

NSCLC patients 387 missing data

Arm/Group Title	No Cachexia	Pre-cachexia	Cachexia	Refractory Cachexia
Arm/Group Description	1) no weight loss (WL<2%) or 2) weight gain AND no anorexia AND no sarcopenia	1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss < 2% AND sarcopenia	1) Weight loss > 5% OR 2) weight loss between 2 and 5% AND BMI < 20 kg/m² OR 3) weight loss > 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage	ECOG 3 or 4 AND low survival expectancy [BMI < 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]
Measure Participants	17	18	25	0
Median (Inter-Quartile Range) [g/L]	4.58	4.75	4.96

17. Secondary Outcome

Title	Description of the Quality of Life Associated With the Different Stages of Cachexia.
Description	Quality of life has been analysed using scores from the functional scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 items (EORTC QLQ-C30 questionnaire): score ranging from 0 (malfunction) to 100 (healthy level of functioning) for the following parameters : physical, role, cognitive, emotional and social scales
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

NSCLC patients Physical scale: 16 missing data Role scale: 17 missing data Cognitive scale: 16 missing data Emotional scale: 16 missing data Social scale: 18 missing data

Arm/Group Title	Physical Scale	Role Scale	Cognitive Scale	Emotional Scale	Social Scale
Arm/Group Description	score ranging from 0 (malfunction) to 100 (healthy level of functioning)	score ranging from 0 (malfunction) to 100 (healthy level of functioning)	score ranging from 0 (malfunction) to 100 (healthy level of functioning)	score ranging from 0 (malfunction) to 100 (healthy level of functioning)	score ranging from 0 (malfunction) to 100 (healthy level of functioning)
Measure Participants	431	430	431	431	429
No Cachexia	76.6 (20.1)	77.6 (26.9)	84.5 (21.0)	82.0 (18.2)	84.9 (21.3)
Pre-Cachexia	67.0 (21.4)	62.6 (32.5)	79.7 (23.4)	71.5 (25.1)	72.0 (28.9)
Cachexia	62.8 (24.5)	56.2 (35.5)	79.1 (22.3)	68.1 (24.8)	67.8 (31.7)
Refractory Cachexia	13.3 (9.4)	0.0 (0.0)	83.3 (19.2)	45.8 (35.0)	12.5 (8.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NSCLC Patients With Cachexia
	Comments	Statistical analysis compares all cachexia stages.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	NSCLC Patients With Cachexia
	Comments	Statistical analysis compares all cachexia stages.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Without refractory cachexia
	Method	Kruskal-Wallis
	Comments	Without refractory cachexia

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cancer Stage IIIA
	Comments	Statistical analysis compares all cachexia stages.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cancer Stage IIIA
	Comments	Statistical analysis compares all cachexia stages.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Without refractory cachexia
	Method	Kruskal-Wallis
	Comments	Without refractory cachexia

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cancer Stage IIIB- IV
	Comments	Statistical analysis compares all cachexia stages.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1085
	Comments
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Cancer Stage IIIB- IV
	Comments	Statistical analysis compares all cachexia stages.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0482
	Comments	Without refractory cachexia
	Method	Kruskal-Wallis
	Comments	Without refractory cachexia

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	3 NSCLC Treatments
	Comments	Statistical analysis compares all cachexia stages.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	3 NSCLC Treatments
	Comments	Statistical analysis compares all cachexia stages.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Without refractory cachexia
	Method	Kruskal-Wallis
	Comments	Without refractory cachexia

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	at Least 4 NSCLC Treatments
	Comments	Statistical analysis compares all cachexia stages.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	at Least 4 NSCLC Treatments
	Comments	Statistical analysis compares all cachexia stages.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Without refractory cachexia
	Method	Kruskal-Wallis
	Comments	Without refractory cachexia

18. Secondary Outcome

Title	Description of the Level of Physical Activity Associated With the Different Stages of Cachexia.
Description	Three levels of physical activity are defined: - Low No activity is reported OR An activity is reported but does not reach moderate or high levels. - Moderate Corresponds to one of the following 3 criteria: 3 or more days of intense activity lasting at least 20 min per day OR 5 or more days of moderate intensity activity and / or walking for at least 30 min per day OR 5 or more days of activity combining walking, activities of moderate or high intensity, thus achieving at least 600 MET-minutes / week - High Corresponds to one of the following 2 criteria: Intense activity at least 3 days a week and at least 1500 MET-minutes / week OR 7 or more days of activity combining walking, moderate and high intensity activities, achieving at least 3000 MET-minutes / week
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

NSCLC patients 69 missing data

Arm/Group Title	No Cachexia	Pre-cachexia	Cachexia	Refractory Cachexia
Arm/Group Description	1) no weight loss (WL<2%) or 2) weight gain AND no anorexia AND no sarcopenia	1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss < 2% AND sarcopenia	1) Weight loss > 5% OR 2) weight loss between 2 and 5% AND BMI < 20 kg/m² OR 3) weight loss > 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage	ECOG 3 or 4 AND low survival expectancy [BMI < 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]
Measure Participants	102	128	144	4
Low	30 5.6%	56 NaN	78 NaN	4 NaN
Moderate	34 6.4%	42 NaN	39 NaN	0 NaN
High	38 7.2%	30 NaN	27 NaN	0 NaN

19. Secondary Outcome

Title	Number of Participants Receiving a Pharmacological Treatment for Cachexia or for Associated Symptoms
Description	Pharmacological treatment of cachexia or associated symptoms: Yes / No
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

NSCLC patients 225 missing data

Arm/Group Title	No Cachexia	Pre-cachexia	Cachexia	Refractory Cachexia
Arm/Group Description	1) no weight loss (WL<2%) or 2) weight gain AND no anorexia AND no sarcopenia	1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss < 2% AND sarcopenia	1) Weight loss > 5% OR 2) weight loss between 2 and 5% AND BMI < 20 kg/m² OR 3) weight loss > 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage	ECOG 3 or 4 AND low survival expectancy [BMI < 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]
Measure Participants	47	69	103	3
Count of Participants [Participants]	0 0%	0 NaN	1 NaN	0 NaN

20. Secondary Outcome

Title	Number of Participants Receiving a Non-Pharmacological Treatment for Cachexia or for Associated Symptoms
Description	Non-pharmacological treatment of cachexia or associated symptoms: Y/N
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

NLSCS patients with a nutritional consultation within 2 months before inclusion 1 missing data

Arm/Group Title	No Cachexia	Pre-cachexia	Cachexia	Refractory Cachexia
Arm/Group Description	1) no weight loss (WL<2%) or 2) weight gain AND no anorexia AND no sarcopenia	1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss < 2% AND sarcopenia	1) Weight loss > 5% OR 2) weight loss between 2 and 5% AND BMI < 20 kg/m² OR 3) weight loss > 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage	ECOG 3 or 4 AND low survival expectancy [BMI < 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]
Measure Participants	25	42	80	3
Count of Participants [Participants]	24 4.5%	41 NaN	77 NaN	3 NaN

21. Secondary Outcome

Title	Number of Participants Receiving Systemic Corticosteroids, Anti-inflammatory Drugs, Omega 3 Fatty Acids Treatments
Description	Treatments with systemic corticosteroids, anti-inflammatory drugs, Omega 3 fatty acids: Yes/No
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

NSCLC patients 11 missing data

Arm/Group Title	No Cachexia	Pre-cachexia	Cachexia	Refractory Cachexia
Arm/Group Description	1) no weight loss (WL<2%) or 2) weight gain AND no anorexia AND no sarcopenia	1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss < 2% AND sarcopenia	1) Weight loss > 5% OR 2) weight loss between 2 and 5% AND BMI < 20 kg/m² OR 3) weight loss > 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage	ECOG 3 or 4 AND low survival expectancy [BMI < 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]
Measure Participants	118	148	166	4
Count of Participants [Participants]	35 6.6%	60 NaN	76 NaN	3 NaN

22. Secondary Outcome

Title	Number of Participants With Diabetes Treatments
Description	Diabetes treatments : Yes/No
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

NSCLC patients 6 missing data

Arm/Group Title	No Cachexia	Pre-cachexia	Cachexia	Refractory Cachexia
Arm/Group Description	1) no weight loss (WL<2%) or 2) weight gain AND no anorexia AND no sarcopenia	1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss < 2% AND sarcopenia	1) Weight loss > 5% OR 2) weight loss between 2 and 5% AND BMI < 20 kg/m² OR 3) weight loss > 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage	ECOG 3 or 4 AND low survival expectancy [BMI < 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]
Measure Participants	117	151	169	4
Count of Participants [Participants]	9 1.7%	15 NaN	20 NaN	0 NaN

23. Secondary Outcome

Title	Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Cachexia
Description	Proportion of patients with cachexia according to the subjective assessment of the clinician Proportion of patients with cachexia according to the Fearon criteria
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

NSCLC patients Cachexia according to Investigator: 4 missing data Cachexia according to Fearon criteria: 84 missing data

Arm/Group Title	Cachexia According to Investigator	Cachexia According to Fearon Criteria
Arm/Group Description	Patients with cachexia according to the subjective assessment of the clinician	1) Weight loss > 5% OR 2) weight loss between 2 and 5% AND BMI < 20 kg/m² OR 3) weight loss > 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage
Measure Participants	527	447
Count of Participants [Participants]	53 10%	173 NaN

24. Secondary Outcome

Title	Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Anorexia
Description	Proportion of patients with anorexia according to the subjective assessment of the clinician Proportion of patients with anorexia according to the Ingesta VAS Proportion of patients with anorexia according to the AC/S-FAACT module score Proportion of patients with anorexia according to question 13 of the QLQ-C30 questionnaire: "Have you had a lack of appetite?"
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

NSCLC patients Anorexia according to Investigator: 3 missing data Anorexia according to VAS: 22 missing data Anorexia according to FAACT: 19 missing data Anorexia according to question 13 of QLQ-C30 questionnaire: 33 missing data

Arm/Group Title	Anorexia According to Investigator	Anorexia According to VAS	Anorexia According to FAACT	Anorexia According to Question 13 of QLQ-C30 Questionnaire
Arm/Group Description	Patients with anorexia according to the subjective assessment of the clinician	Patients with anorexia according to Visual analogue scale for dietary intake.: "Could you indicate the amount you currently eat, placing a vertical mark on the line between "nothing at all" and "as usual"? Depending on the location of the patient mark on the scale, a score of between 0 ("nothing at all") and 10 ("as usual") was allocated. anorexia if score*100/990< 70mm.	Patients with anorexia according to Anorexia Cachexia/Subcale (AC/S) module of the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) questionnaire: anorexia if score <=37	Patients with anorexia according to question 13 of the QLQ-C30 questionnaire: "Have you had a lack of appetite?": anorexia if answer is a A little bit, Somewhat, Quite a bit
Measure Participants	528	509	512	498
Count of Participants [Participants]	109 20.5%	166 NaN	273 NaN	219 NaN

25. Secondary Outcome

Title	Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Malnutrition
Description	Proportion of patients with severe malnutrition according to the subjective assessment of the clinician Proportion of patients with severe malnutrition according to the malnutrition criteria defined by the HAS.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

NSCLC patients Severe malnutrition according to Investigator: 15 missing data Severe malnutrition according to the HAS: 416 missing data

Arm/Group Title	Severe Malnutrition According to Investigator	Severe Malnutrition According to the HAS
Arm/Group Description	Patients with severe malnutrition according to the subjective assessment of the clinician	Patients with malnutrition according to the Haute Autorité de Santé: weight loss ≥ 10%, BMI measured during the inclusion visit <18.5 kg / m² for patients aged 70 and under and <21 kg / m² for patients over 70 years of age Albumin <30 g / L if patient <70 years; or albumin <35g / L if patient ≥ 70 years Pre-albumin <110 mg / L if patient <70 years
Measure Participants	516	115
Count of Participants [Participants]	52 9.8%	55 NaN

Adverse Events

Adverse Event Reporting Description	This is a non-interventional epidemiological study. No safety data was collected. No reporting of adverse reaction is expected in the study.
Arm/Group Title	No Safety Data Was Collected
Arm/Group Description	This is a non-interventional epidemiological study. No reporting of adverse reaction is expected in the study.
All Cause Mortality
	No Safety Data Was Collected
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	No Safety Data Was Collected
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	No Safety Data Was Collected
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Study may not be published by the Health Institution or the Investigator without the prior written consent of the Promoter who has to respond as soon as possible. If the Investigator wishes to proceed with a publication or communication relating to the Study, the Promoter may, in the event that a serious and valid reason appears to require it, request that certain modifications be made. The modifications cannot in any way affect the scientific value of the publication.