TriangleNCT00102804 · STUDY IN CONTEXT
Pemetrexed and Best Supportive Care Versus Placebo and Best Supportive Care in Non-Small Cell Lung Cancer (NSCLC)
Draft scope assessment: unclear. Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
PFS time was the elapsed time from the date of randomization to the first date of objective progression of disease or death from any cause. PFS was censored at the date of the participant's last tumor assessment for participants who were not known to have died or to have PD as of the data-inclusion cut-off date for analysis. PD, defined using Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0), was at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
OS time was the elapsed time from the date of randomization to the date of death from any cause. OS was censored at the last date of contact for participants who were not known to have died as of the data-inclusion cut-off date for analysis.
TPD was the elapsed time from the date of randomization to the first date of objective PD. TPD was censored at the date of the participant's last tumor assessment for participants who were not known to have PD as of the data-inclusion cut-off date for analysis or who died without objective PD. PD, defined using RECIST v1.0, was at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
TWS was the elapsed time from the date of randomization to the first date of worsening \[defined as a 15-millimeter (mm) increase from baseline based on a 100-mm scale\] of each symptom and summary item in the Lung Cancer Symptom Scale (LCSS). The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant (pt) responses to each item were measured using visual analogue scales (VAS) from 0 (for best outcome) to 100 (for worst outcome). TWS was censored at the date of the last LCSS assessment for pts who were not known to have LCSS worsening.
Response was defined using RECIST v1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined either A) at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LDs or B) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared. The percentage of participants with CR or PR=(Number of participants with CR or PR)/(Number of participants assessed)\*100.
Clinically significant events were defined as serious adverse events (SAEs) and other non-serious AEs regardless of causality. A summary of serious and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Reported safety
Quality of life and patient-reported measures
Unnamed quality-of-life measure · Time to Worsening of Symptoms (TWS)
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- qol key
- qol-0003
- source section id
- NCT00102804-om-0003
- source outcome index
- 3
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Time to Worsening of Symptoms (TWS)
- measure definition
- TWS was the elapsed time from the date of randomization to the first date of worsening \[defined as a 15-millimeter (mm) increase from baseline based on a 100-mm scale\] of each symptom and summary item in the Lung Cancer Symptom Scale (LCSS). The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant (pt) responses to each item were measured using visual analogue scales (VAS) from 0 (for best outcome) to 100 (for worst outcome). TWS was censored at the date of the last LCSS assessment for pts who were not known to have LCSS worsening.
- time frame
- Randomization to worsening of each LCSS item (up to 39 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Pts who signed ICF and completed randomization, according to treatment randomized. Pts censored: Loss of appetite 236,140; fatigue 237,130; cough 274,146; dyspnea 271,143, hemoptysis 404,198; pain 271,135; symptom distress 247,141; interference with activity level 267,141, global quality of life 262,137 pts in pemetrexed, placebo arm, respectively.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Maximum Improvement Over Baseline in Individual Symptom Scores and Quality of Life Using the LCSS
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- qol key
- qol-0006
- source section id
- NCT00102804-om-0006
- source outcome index
- 6
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Maximum Improvement Over Baseline in Individual Symptom Scores and Quality of Life Using the LCSS
- measure definition
- The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant responses to each item were measured using VAS from 0 (for best outcome) to 100 (for worst outcome). The average symptom burden index (ASBI) was the mean of the 6 symptom-specific items. The LCSS total score was the mean of the 9 items.
- time frame
- Baseline through 30 days post discontinuation of study treatment (up to 39 Months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Participants who signed the ICF, completed the randomization process, had LCSS data at baseline and at least once postdose are reported according to the treatment arm to which they were randomized.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- trial label
- Pemetrexed and Best Supportive Care Versus Placebo and Best Supportive Care in Non-Small Cell Lung Cancer (NSCLC)
- applicability
- unclear
- applicability note
- Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 2
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- outcome key
- om-0000
- source section id
- NCT00102804-om-0000
- source outcome index
- 0
- endpoint
- Progression-Free Survival (PFS) Time
- endpoint definition
- PFS time was the elapsed time from the date of randomization to the first date of objective progression of disease or death from any cause. PFS was censored at the date of the participant's last tumor assessment for participants who were not known to have died or to have PD as of the data-inclusion cut-off date for analysis. PD, defined using Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0), was at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
- time origin
- Randomization to measured PD or death from any cause (up to 41 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized. Participants censored: N = 123, 36 participants in the pemetrexed and placebo treatment arms, respectively.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- outcome key
- om-0001
- source section id
- NCT00102804-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival (OS) Time
- endpoint definition
- OS time was the elapsed time from the date of randomization to the date of death from any cause. OS was censored at the last date of contact for participants who were not known to have died as of the data-inclusion cut-off date for analysis.
- time origin
- Randomization to date of death from any cause (up to 41 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized. Participants censored: N = 138, 48 participants in the pemetrexed and placebo treatment arms, respectively.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- outcome key
- om-0002
- source section id
- NCT00102804-om-0002
- source outcome index
- 2
- endpoint
- Time to Objective Progressive Disease (TPD)
- endpoint definition
- TPD was the elapsed time from the date of randomization to the first date of objective PD. TPD was censored at the date of the participant's last tumor assessment for participants who were not known to have PD as of the data-inclusion cut-off date for analysis or who died without objective PD. PD, defined using RECIST v1.0, was at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
- time origin
- Randomization to measured PD (up to 41 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized. Participants censored: N = 145, 40 participants in the pemetrexed and placebo treatment arms, respectively.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- outcome key
- om-0003
- source section id
- NCT00102804-om-0003
- source outcome index
- 3
- endpoint
- Time to Worsening of Symptoms (TWS)
- endpoint definition
- TWS was the elapsed time from the date of randomization to the first date of worsening \[defined as a 15-millimeter (mm) increase from baseline based on a 100-mm scale\] of each symptom and summary item in the Lung Cancer Symptom Scale (LCSS). The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant (pt) responses to each item were measured using visual analogue scales (VAS) from 0 (for best outcome) to 100 (for worst outcome). TWS was censored at the date of the last LCSS assessment for pts who were not known to have LCSS worsening.
- time origin
- Randomization to worsening of each LCSS item (up to 39 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Pts who signed ICF and completed randomization, according to treatment randomized. Pts censored: Loss of appetite 236,140; fatigue 237,130; cough 274,146; dyspnea 271,143, hemoptysis 404,198; pain 271,135; symptom distress 247,141; interference with activity level 267,141, global quality of life 262,137 pts in pemetrexed, placebo arm, respectively.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- outcome key
- om-0004
- source section id
- NCT00102804-om-0004
- source outcome index
- 4
- endpoint
- Percentage of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate)
- endpoint definition
- Response was defined using RECIST v1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined either A) at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LDs or B) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared. The percentage of participants with CR or PR=(Number of participants with CR or PR)/(Number of participants assessed)\*100.
- time origin
- Baseline to measured PD (up to 41 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- outcome key
- om-0005
- source section id
- NCT00102804-om-0005
- source outcome index
- 5
- endpoint
- Number of Participants With Adverse Events (AEs)
- endpoint definition
- Clinically significant events were defined as serious adverse events (SAEs) and other non-serious AEs regardless of causality. A summary of serious and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
- time origin
- Baseline to study completion (up to 41 Months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who signed the ICF, completed the randomized process and received at least 1 dose of study drug are reported according to the treatment to which they were received.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Pemetrexed and BSC
- regimen
- Pemetrexed: 500 mg/m\^2, IV administration, q 21 days, until disease progression. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
- analyzed count
- 441
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00102804-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Placebo and BSC
- regimen
- Placebo: IV administration, q 21 days. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
- analyzed count
- 222
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00102804-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Pemetrexed and BSC
- regimen
- Pemetrexed: 500 mg/m\^2, IV administration, q 21 days, until disease progression. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
- analyzed count
- 441
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00102804-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Placebo and BSC
- regimen
- Placebo: IV administration, q 21 days. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
- analyzed count
- 222
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00102804-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Pemetrexed and BSC
- regimen
- Pemetrexed: 500 mg/m\^2, IV administration, q 21 days, until disease progression. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
- analyzed count
- 441
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00102804-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Placebo and BSC
- regimen
- Placebo: IV administration, q 21 days. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
- analyzed count
- 222
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00102804-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Pemetrexed and BSC
- regimen
- Pemetrexed: 500 mg/m\^2, IV administration, q 21 days, until disease progression. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
- analyzed count
- 441
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00102804-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Placebo and BSC
- regimen
- Placebo: IV administration, q 21 days. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
- analyzed count
- 222
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00102804-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Pemetrexed and BSC
- regimen
- Pemetrexed: 500 mg/m\^2, IV administration, q 21 days, until disease progression. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
- analyzed count
- 441
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00102804-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Placebo and BSC
- regimen
- Placebo: IV administration, q 21 days. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
- analyzed count
- 222
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00102804-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Pemetrexed and BSC
- regimen
- Pemetrexed: 500 mg/m\^2, IV administration, q 21 days, until disease progression. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
- analyzed count
- 438
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00102804-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Placebo and BSC
- regimen
- Placebo: IV administration, q 21 days. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
- analyzed count
- 218
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00102804-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- harm key
- EG000
- source section id
- NCT00102804-ae
- event group key
- EG000
- event group label
- Pemetrexed and BSC
- serious affected
- 83
- serious at risk
- 438
- other affected
- 386
- other at risk
- 438
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Participants are reported under the treatment to which they received.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- harm key
- EG001
- source section id
- NCT00102804-ae
- event group key
- EG001
- event group label
- Placebo and BSC
- serious affected
- 31
- serious at risk
- 218
- other affected
- 178
- other at risk
- 218
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Participants are reported under the treatment to which they received.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- qol key
- qol-0003
- source section id
- NCT00102804-om-0003
- source outcome index
- 3
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Time to Worsening of Symptoms (TWS)
- measure definition
- TWS was the elapsed time from the date of randomization to the first date of worsening \[defined as a 15-millimeter (mm) increase from baseline based on a 100-mm scale\] of each symptom and summary item in the Lung Cancer Symptom Scale (LCSS). The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant (pt) responses to each item were measured using visual analogue scales (VAS) from 0 (for best outcome) to 100 (for worst outcome). TWS was censored at the date of the last LCSS assessment for pts who were not known to have LCSS worsening.
- time frame
- Randomization to worsening of each LCSS item (up to 39 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Pts who signed ICF and completed randomization, according to treatment randomized. Pts censored: Loss of appetite 236,140; fatigue 237,130; cough 274,146; dyspnea 271,143, hemoptysis 404,198; pain 271,135; symptom distress 247,141; interference with activity level 267,141, global quality of life 262,137 pts in pemetrexed, placebo arm, respectively.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
- nct id
- NCT00102804
- qol key
- qol-0006
- source section id
- NCT00102804-om-0006
- source outcome index
- 6
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Maximum Improvement Over Baseline in Individual Symptom Scores and Quality of Life Using the LCSS
- measure definition
- The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant responses to each item were measured using VAS from 0 (for best outcome) to 100 (for worst outcome). The average symptom burden index (ASBI) was the mean of the 6 symptom-specific items. The LCSS total score was the mean of the 9 items.
- time frame
- Baseline through 30 days post discontinuation of study treatment (up to 39 Months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Participants who signed the ICF, completed the randomization process, had LCSS data at baseline and at least once postdose are reported according to the treatment arm to which they were randomized.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice