Trial Outcomes & Findings for Prognostic Value of Sarcopenia and Nutritional Status in Early-stage Non-small Cell Lung Cancer (NCT NCT05212285)
NCT ID: NCT05212285
Last Updated: 2025-08-01
Results Overview
Due to the treatment frequency of lung cancer, we implemented the following follow-up schedule with actual follow-up completed for five years. Progression-free survival was measured from the date of diagnosis until the first occurrence of either: Objective tumor progression (confirmed by imaging per RECIST criteria), or death from any cause. whichever occurred first.
Recruitment status
COMPLETED
Target enrollment
469 participants
Primary outcome timeframe
Follow-up were conducted every 2months during the first year and every 6 months for up to 5 years from enrollment. Progression-free survival was measured from the date of diagnosis until confirmed disease progression or death, whichever occurred first.
Results posted on
2025-08-01
Participant Flow
The patients were diagnosed with non-small cell lung cancer (NSCLC) by cytological or pathological examination and met the relevant criteria of the Chinese Medical Association Guidelines for Clinical Diagnosis and Treatment of Lung Cancer (2018 Edition). The TNM staging of lung cancer was confirmed as stage IA-IIIA.
Participant milestones
| Measure |
Early-stage NSCLC With Sarcopenia
Patients diagnosed with NSCLC meeting Stage IA-IIIA as well as sarcopenia by the enrollment
Inbody 570: Bioelectrical Impedance Analysis with Inbody 570 (Inbody Co., Seoul, Korea) during each follow-up
JAMAR Dynamometer: Handgrip strength measurement using a JAMAR Dynamometer (JAMAR Co., Ltd., USA) during each follow-up
CT scan: Chest and abdominal CT scan during each follow-up
|
Early-stage NSCLC Without Sarcopenia
Patients diagnosed with NSCLC meeting Stage IA-IIIA but without sarcopenia by the enrollment
Inbody 570: Bioelectrical Impedance Analysis with Inbody 570 (Inbody Co., Seoul, Korea) during each follow-up
JAMAR Dynamometer: Handgrip strength measurement using a JAMAR Dynamometer (JAMAR Co., Ltd., USA) during each follow-up
CT scan: Chest and abdominal CT scan during each follow-up
|
|---|---|---|
|
Overall Study
STARTED
|
228
|
241
|
|
Overall Study
COMPLETED
|
174
|
229
|
|
Overall Study
NOT COMPLETED
|
54
|
12
|
Reasons for withdrawal
| Measure |
Early-stage NSCLC With Sarcopenia
Patients diagnosed with NSCLC meeting Stage IA-IIIA as well as sarcopenia by the enrollment
Inbody 570: Bioelectrical Impedance Analysis with Inbody 570 (Inbody Co., Seoul, Korea) during each follow-up
JAMAR Dynamometer: Handgrip strength measurement using a JAMAR Dynamometer (JAMAR Co., Ltd., USA) during each follow-up
CT scan: Chest and abdominal CT scan during each follow-up
|
Early-stage NSCLC Without Sarcopenia
Patients diagnosed with NSCLC meeting Stage IA-IIIA but without sarcopenia by the enrollment
Inbody 570: Bioelectrical Impedance Analysis with Inbody 570 (Inbody Co., Seoul, Korea) during each follow-up
JAMAR Dynamometer: Handgrip strength measurement using a JAMAR Dynamometer (JAMAR Co., Ltd., USA) during each follow-up
CT scan: Chest and abdominal CT scan during each follow-up
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
12
|
8
|
|
Overall Study
Withdrawal by Subject
|
8
|
1
|
|
Overall Study
Lost to Follow-up
|
13
|
1
|
|
Overall Study
miss data
|
21
|
2
|
Baseline Characteristics
Prognostic Value of Sarcopenia and Nutritional Status in Early-stage Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Early-stage NSCLC Without Sarcopenia
n=229 Participants
Patients diagnosed with NSCLC meeting Stage IA-IIIA but without sarcopenia by the enrollment
Inbody 570: Bioelectrical Impedance Analysis with Inbody 570 (Inbody Co., Seoul, Korea) during each follow-up
JAMAR Dynamometer: Handgrip strength measurement using a JAMAR Dynamometer (JAMAR Co., Ltd., USA) during each follow-up
CT scan: Chest and abdominal CT scan during each follow-up
|
Early-stage NSCLC With Sarcopenia
n=174 Participants
Patients diagnosed with NSCLC meeting Stage IA-IIIA as well as sarcopenia by the enrollment
Inbody 570: Bioelectrical Impedance Analysis with Inbody 570 (Inbody Co., Seoul, Korea) during each follow-up
JAMAR Dynamometer: Handgrip strength measurement using a JAMAR Dynamometer (JAMAR Co., Ltd., USA) during each follow-up
CT scan: Chest and abdominal CT scan during each follow-up
|
Total
n=403 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
179 Participants
n=99 Participants
|
154 Participants
n=107 Participants
|
333 Participants
n=206 Participants
|
|
Age, Continuous
|
71 years
STANDARD_DEVIATION 8.2 • n=99 Participants
|
74.3 years
STANDARD_DEVIATION 7.7 • n=107 Participants
|
72.2 years
STANDARD_DEVIATION 8.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
156 Participants
n=99 Participants
|
133 Participants
n=107 Participants
|
289 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
229 Participants
n=99 Participants
|
174 Participants
n=107 Participants
|
403 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
walking speed
|
0.7 m/s
STANDARD_DEVIATION 0.3 • n=99 Participants
|
1.0 m/s
STANDARD_DEVIATION 0.3 • n=107 Participants
|
0.9 m/s
STANDARD_DEVIATION 0.3 • n=206 Participants
|
|
handgrip sthength
|
30.8 kg
STANDARD_DEVIATION 7.8 • n=99 Participants
|
23.4 kg
STANDARD_DEVIATION 7.1 • n=107 Participants
|
27.4 kg
STANDARD_DEVIATION 8.4 • n=206 Participants
|
|
Skeletal muscle mass index
|
7.2 kg/m^2
STANDARD_DEVIATION 0.9 • n=99 Participants
|
6.3 kg/m^2
STANDARD_DEVIATION 0.7 • n=107 Participants
|
6.8 kg/m^2
STANDARD_DEVIATION 0.9 • n=206 Participants
|
|
cancer stage
I-II
|
56 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
cancer stage
III-IV
|
173 Participants
n=99 Participants
|
146 Participants
n=107 Participants
|
319 Participants
n=206 Participants
|
|
Smoking status
Smoker
|
32 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Smoking status
Ex-smoker
|
74 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
|
Smoking status
Non-smoker
|
123 Participants
n=99 Participants
|
103 Participants
n=107 Participants
|
226 Participants
n=206 Participants
|
|
nrs2002 score
|
2.6 score on a scale
STANDARD_DEVIATION 1.2 • n=99 Participants
|
3.7 score on a scale
STANDARD_DEVIATION 1.6 • n=107 Participants
|
3.1 score on a scale
STANDARD_DEVIATION 1.5 • n=206 Participants
|
|
Historical type
adenocarcinoma
|
149 Participants
n=99 Participants
|
113 Participants
n=107 Participants
|
262 Participants
n=206 Participants
|
|
Historical type
squamous cell carcinoma
|
51 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Historical type
small cell lung cancer
|
23 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Historical type
others
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Follow-up were conducted every 2months during the first year and every 6 months for up to 5 years from enrollment. Progression-free survival was measured from the date of diagnosis until confirmed disease progression or death, whichever occurred first.Due to the treatment frequency of lung cancer, we implemented the following follow-up schedule with actual follow-up completed for five years. Progression-free survival was measured from the date of diagnosis until the first occurrence of either: Objective tumor progression (confirmed by imaging per RECIST criteria), or death from any cause. whichever occurred first.
Outcome measures
| Measure |
Early-stage NSCLC With Sarcopenia
n=174 Participants
Patients who exhibiting disease progression with sarcopenia
|
Early-stage NSCLC Without Sarcopenia
n=229 Participants
Patients who exhibiting disease progression without sarcopenia
|
|---|---|---|
|
Progression Free Survival (PFS)
|
350 days
Standard Error 46.4
|
773 days
Standard Error 46.1
|
SECONDARY outcome
Timeframe: Follow-up were conducted every 2months during the first year and every 6 months for up to 5 years from enrollment. overall survival was measured from the date of diagnosis until death or the final follow-up time.Outcome of patient death from diagnosis to any cause or the final follow-up time
Outcome measures
| Measure |
Early-stage NSCLC With Sarcopenia
n=174 Participants
Patients who exhibiting disease progression with sarcopenia
|
Early-stage NSCLC Without Sarcopenia
n=229 Participants
Patients who exhibiting disease progression without sarcopenia
|
|---|---|---|
|
Overall Survival (OS)
|
1319 days
Standard Error 172.5
|
402 days
Standard Error 49.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, 18 and 24 months after enrollment and up to 5 years if feasibleGrip strength test at the follow-ups timepoints
Outcome measures
Outcome data not reported
Adverse Events
Lung Cancer With Sarcopenia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 123 deaths
Lung Cancer Without Sarcopenia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 76 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr.Yinggang Zhu,Dr Ting Zhao
Huadong hospital,Shanghai ,China
Phone: 1374321007
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place