Trial Outcomes & Findings for Chemotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC) (NCT NCT00391274)
NCT ID: NCT00391274
Last Updated: 2011-04-12
Results Overview
Overall survival was defined as the time from the date of study enrollment to the date of death due to any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up. An amendment allowed for the collection of overall survival on an additional 43 survival events. At the time the original record was released, it was not possible to provide results with the 95% Confidence Interval (CI) since the upper limit was not calculable. The median and 95% CIs are now reported.
COMPLETED
PHASE3
211 participants
baseline to date of death from any cause (up to 24 months after study enrollment); amendment (up to 30 months after study enrollment)
2011-04-12
Participant Flow
Participant milestones
| Measure |
Pemetrexed
500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
|
Docetaxel
75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
104
|
|
Overall Study
Received at Least One Dose of Study Drug
|
106
|
102
|
|
Overall Study
COMPLETED
|
46
|
47
|
|
Overall Study
NOT COMPLETED
|
61
|
57
|
Reasons for withdrawal
| Measure |
Pemetrexed
500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
|
Docetaxel
75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
|
|---|---|---|
|
Overall Study
Death Due to Study Disease
|
55
|
45
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
|
Overall Study
Physician Decision
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Death Due to Adverse Event
|
1
|
3
|
|
Overall Study
Death Due to Indeterminate Cause
|
1
|
0
|
|
Overall Study
Death Not Study Related
|
0
|
1
|
Baseline Characteristics
Chemotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Pemetrexed
n=107 Participants
500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
|
Docetaxel
n=104 Participants
75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
56.4 years
STANDARD_DEVIATION 9.33 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 11.41 • n=7 Participants
|
56.1 years
STANDARD_DEVIATION 10.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
107 participants
n=5 Participants
|
104 participants
n=7 Participants
|
211 participants
n=5 Participants
|
|
Region of Enrollment
China
|
107 participants
n=5 Participants
|
104 participants
n=7 Participants
|
211 participants
n=5 Participants
|
|
Basis for Pathological Diagnosis
Cytological
|
34 participants
n=5 Participants
|
35 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Basis for Pathological Diagnosis
Histopathological
|
73 participants
n=5 Participants
|
69 participants
n=7 Participants
|
142 participants
n=5 Participants
|
|
Disease Stage
Stage IIIA
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Disease Stage
Stage IIIB
|
24 participants
n=5 Participants
|
18 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Disease Stage
Stage IV
|
81 participants
n=5 Participants
|
84 participants
n=7 Participants
|
165 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 - Fully Active
|
11 participants
n=5 Participants
|
16 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 - Ambulatory, Restricted Strenuous Activity
|
84 participants
n=5 Participants
|
77 participants
n=7 Participants
|
161 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2 - Ambulatory, No Work Activities
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Number of Sites of Metastatic Disease
1 Site
|
10 participants
n=5 Participants
|
15 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Number of Sites of Metastatic Disease
2 Sites
|
32 participants
n=5 Participants
|
31 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Number of Sites of Metastatic Disease
3 Sites
|
34 participants
n=5 Participants
|
30 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Number of Sites of Metastatic Disease
4 Sites
|
11 participants
n=5 Participants
|
12 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Number of Sites of Metastatic Disease
5 Sites
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Number of Sites of Metastatic Disease
6 Sites
|
4 participants
n=5 Participants
|
8 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Number of Sites of Metastatic Disease
7 Sites
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Number of Sites of Metastatic Disease
8 Sites
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Number of Sites of Metastatic Disease
9 Sites
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Number of Sites of Metastatic Disease
10 Sites
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Pathological Diagnosis
Adenocarcinoma
|
75 participants
n=5 Participants
|
73 participants
n=7 Participants
|
148 participants
n=5 Participants
|
|
Pathological Diagnosis
Carcinoma, Squamous Cell
|
27 participants
n=5 Participants
|
25 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Pathological Diagnosis
Mixed Cell Carcinoma, Lung
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Pathological Diagnosis
Missing
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Smoking Status
Never Smoked
|
50 participants
n=5 Participants
|
49 participants
n=7 Participants
|
99 participants
n=5 Participants
|
|
Smoking Status
Smoked, But Quit
|
53 participants
n=5 Participants
|
44 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Smoking Status
Currently Smoking
|
4 participants
n=5 Participants
|
11 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to date of death from any cause (up to 24 months after study enrollment); amendment (up to 30 months after study enrollment)Population: Intent to treat population. Number of patients censored (up to 24 months): pemetrexed = 51, docetaxel = 55. Number of participants censored (up to 30 months): pemetrexed = 30, docetaxel = 32.
Overall survival was defined as the time from the date of study enrollment to the date of death due to any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up. An amendment allowed for the collection of overall survival on an additional 43 survival events. At the time the original record was released, it was not possible to provide results with the 95% Confidence Interval (CI) since the upper limit was not calculable. The median and 95% CIs are now reported.
Outcome measures
| Measure |
Pemetrexed
n=107 Participants
500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
|
Docetaxel
n=104 Participants
75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
|
|---|---|---|
|
Overall Survival
Overall Survival (up to 24 months)
|
11.7 months
Interval 8.7 to
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
12.2 months
Interval 9.1 to
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
|
Overall Survival
Overall Survival (up to 30 months)
|
11.4 months
Interval 8.6 to 13.4
|
11.5 months
Interval 8.9 to 15.2
|
SECONDARY outcome
Timeframe: baseline to measured tumor response (up to 24 months after study enrollment)Population: Patients who received at least one dose of study drug and qualified for tumor response analysis (met following criteria: histologic or cytologic diagnosis of NSCLC that was not amenable to curative therapy; no concurrent systemic chemotherapy; presence of measurable or evaluable disease).
Response based on Response Evaluation Criteria In Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions; SD (stable disease) = small changes that do not meet above criteria.
Outcome measures
| Measure |
Pemetrexed
n=104 Participants
500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
|
Docetaxel
n=98 Participants
75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
|
|---|---|---|
|
Overall Tumor Response
Complete Response
|
0 participants
|
0 participants
|
|
Overall Tumor Response
Partial Response
|
10 participants
|
4 participants
|
|
Overall Tumor Response
Stable Disease
|
33 participants
|
46 participants
|
|
Overall Tumor Response
Progressive Disease
|
49 participants
|
36 participants
|
|
Overall Tumor Response
Early Death from Malignant Disease
|
7 participants
|
6 participants
|
|
Overall Tumor Response
Early Death from Other Causes
|
1 participants
|
1 participants
|
|
Overall Tumor Response
Unknown
|
4 participants
|
5 participants
|
SECONDARY outcome
Timeframe: baseline to measured progressive disease (up to 24 months after study enrollment)Population: Intent to treat population. Patient censored: pemetrexed=25, docetaxel=39.
Progression-free survival (PFS) time was defined as the time from the date of study enrollment to the date of the first of the following events: objective disease progression or death due to any cause. For patients who were alive and had not progressed, PFS was censored at the last contact.
Outcome measures
| Measure |
Pemetrexed
n=107 Participants
500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
|
Docetaxel
n=104 Participants
75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
2.8 months
Interval 1.8 to 3.1
|
3.1 months
Interval 2.8 to 3.7
|
SECONDARY outcome
Timeframe: time of response to progressive disease (up to 24 months)Population: Patients who qualified for response (met following criteria: histologic or cytologic diagnosis of NSCLC that was not amenable to curative therapy; no concurrent systemic chemotherapy; presence of measurable or evaluable disease). Results not presented because median was not calculable for the docetaxel arm.
Duration of tumor response is the duration from date of first objective status assessment of a complete or partial response to the first date of progression or death from any cause. For each patient who is not known to have died or to have had a progression of disease as of the data inclusion cut-off date, duration of tumor response was censored at the time of last prior contact. Due to the low number of patients in the analysis, the median duration of tumor response could not be calculated for the docetaxel arm. Available data are presented as "Number of Patients with Disease Progression".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: first dose of study drug up to 24 monthsPopulation: Patients who received at least one dose of study drug.
Maximum common terminology criteria (CTC) Grade 3 or 4 toxicities possibly related to study drug are reported. The worst grade event per cycle is reported. Grades range from 0 (none) to 5 (death). Grade 3 events are severe and Grade 4 events are life-threatening.
Outcome measures
| Measure |
Pemetrexed
n=106 Participants
500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
|
Docetaxel
n=102 Participants
75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
|
|---|---|---|
|
Pharmacology Toxicity
Serum Glutamic Pyruvic Transaminase
|
1 participants
|
0 participants
|
|
Pharmacology Toxicity
Hemoglobin
|
7 participants
|
3 participants
|
|
Pharmacology Toxicity
Leukocytes
|
4 participants
|
21 participants
|
|
Pharmacology Toxicity
Lymphopenia
|
1 participants
|
0 participants
|
|
Pharmacology Toxicity
Neutrophils/Granulocytes
|
5 participants
|
29 participants
|
|
Pharmacology Toxicity
Platelets
|
7 participants
|
0 participants
|
|
Pharmacology Toxicity
Hypokalemia
|
0 participants
|
1 participants
|
|
Pharmacology Toxicity
Anorexia
|
1 participants
|
0 participants
|
|
Pharmacology Toxicity
Constipation
|
0 participants
|
1 participants
|
|
Pharmacology Toxicity
Diarrhea
|
0 participants
|
5 participants
|
|
Pharmacology Toxicity
Enteritis
|
0 participants
|
1 participants
|
|
Pharmacology Toxicity
Fatigue (Asthenia, Lethargy, Malaise)
|
3 participants
|
5 participants
|
|
Pharmacology Toxicity
Febrile Neutropenia
|
2 participants
|
4 participants
|
|
Pharmacology Toxicity
Infection (Clinical/Microbiological: Neutrophils)
|
0 participants
|
1 participants
|
|
Pharmacology Toxicity
Infection (Unknown: Pneumonia)
|
0 participants
|
1 participants
|
|
Pharmacology Toxicity
Mucositis/Stomatitis
|
1 participants
|
0 participants
|
|
Pharmacology Toxicity
Neuropathy: Motor
|
0 participants
|
1 participants
|
|
Pharmacology Toxicity
Pain: Thorax Not Otherwise Specified (NOS)
|
0 participants
|
1 participants
|
|
Pharmacology Toxicity
Pericardial Effusion (Non-Malignant)
|
1 participants
|
0 participants
|
|
Pharmacology Toxicity
Pulmonary/Upper Respiratory - Other
|
1 participants
|
0 participants
|
|
Pharmacology Toxicity
Rash/Desquamation
|
1 participants
|
0 participants
|
POST_HOC outcome
Timeframe: time of response to progressive disease (up to 12 months)Population: Patients who qualified for response (met following criteria: histologic or cytologic diagnosis of NSCLC that was not amenable to curative therapy; no concurrent systemic chemotherapy; presence of measurable or evaluable disease). Patients censored: pemetrexed=6, docetaxel=3.
Number of patients who have died or have had progression of disease. This outcome substitutes for the outcome on Duration of Response.
Outcome measures
| Measure |
Pemetrexed
n=10 Participants
500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
|
Docetaxel
n=4 Participants
75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
|
|---|---|---|
|
Number of Patients With Disease Progression
|
4 participants
|
1 participants
|
Adverse Events
Pemetrexed
Docetaxel
Serious adverse events
| Measure |
Pemetrexed
n=106 participants at risk
500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
|
Docetaxel
n=102 participants at risk
75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/106
|
0.98%
1/102 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.9%
2/106 • Number of events 2
|
0.00%
0/102
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/106
|
0.98%
1/102 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.94%
1/106 • Number of events 1
|
0.00%
0/102
|
|
Cardiac disorders
Pericardial effusion
|
1.9%
2/106 • Number of events 2
|
0.00%
0/102
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/106
|
0.98%
1/102 • Number of events 1
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/106
|
0.98%
1/102 • Number of events 1
|
|
General disorders
Fatigue
|
0.94%
1/106 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
General disorders
Pyrexia
|
1.9%
2/106 • Number of events 2
|
0.00%
0/102
|
|
Infections and infestations
Lung infection
|
0.00%
0/106
|
0.98%
1/102 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/106
|
0.98%
1/102 • Number of events 1
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/106
|
0.98%
1/102 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/106
|
0.98%
1/102 • Number of events 1
|
|
Investigations
Platelet count decreased
|
0.94%
1/106 • Number of events 2
|
0.00%
0/102
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/106
|
0.98%
1/102 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/106
|
0.98%
1/102 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
2/106 • Number of events 2
|
0.98%
1/102 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.8%
3/106 • Number of events 3
|
0.98%
1/102 • Number of events 1
|
|
Vascular disorders
Shock
|
0.94%
1/106 • Number of events 1
|
0.00%
0/102
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/106
|
0.98%
1/102 • Number of events 1
|
Other adverse events
| Measure |
Pemetrexed
n=106 participants at risk
500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
|
Docetaxel
n=102 participants at risk
75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.5%
9/106 • Number of events 13
|
0.98%
1/102 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/106
|
5.9%
6/102 • Number of events 6
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.8%
4/106 • Number of events 6
|
5.9%
6/102 • Number of events 14
|
|
Gastrointestinal disorders
Abdominal distension
|
5.7%
6/106 • Number of events 8
|
2.9%
3/102 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
7.5%
8/106 • Number of events 12
|
10.8%
11/102 • Number of events 11
|
|
Gastrointestinal disorders
Diarrhoea
|
10.4%
11/106 • Number of events 11
|
14.7%
15/102 • Number of events 20
|
|
Gastrointestinal disorders
Nausea
|
19.8%
21/106 • Number of events 26
|
11.8%
12/102 • Number of events 14
|
|
Gastrointestinal disorders
Vomiting
|
17.9%
19/106 • Number of events 23
|
4.9%
5/102 • Number of events 7
|
|
General disorders
Chest pain
|
5.7%
6/106 • Number of events 6
|
10.8%
11/102 • Number of events 12
|
|
General disorders
Fatigue
|
45.3%
48/106 • Number of events 70
|
41.2%
42/102 • Number of events 71
|
|
General disorders
Oedema peripheral
|
2.8%
3/106 • Number of events 5
|
5.9%
6/102 • Number of events 11
|
|
General disorders
Pyrexia
|
16.0%
17/106 • Number of events 25
|
14.7%
15/102 • Number of events 22
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
6/106 • Number of events 7
|
0.98%
1/102 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
7.5%
8/106 • Number of events 10
|
4.9%
5/102 • Number of events 6
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/106
|
5.9%
6/102 • Number of events 6
|
|
Investigations
Alanine aminotransferase increased
|
31.1%
33/106 • Number of events 55
|
9.8%
10/102 • Number of events 10
|
|
Investigations
Aspartate aminotransferase increased
|
21.7%
23/106 • Number of events 32
|
5.9%
6/102 • Number of events 7
|
|
Investigations
Haemoglobin decreased
|
17.9%
19/106 • Number of events 19
|
15.7%
16/102 • Number of events 17
|
|
Investigations
Neutrophil count decreased
|
12.3%
13/106 • Number of events 20
|
29.4%
30/102 • Number of events 71
|
|
Investigations
Platelet count decreased
|
7.5%
8/106 • Number of events 11
|
4.9%
5/102 • Number of events 6
|
|
Investigations
White blood cell count decreased
|
14.2%
15/106 • Number of events 23
|
30.4%
31/102 • Number of events 91
|
|
Metabolism and nutrition disorders
Anorexia
|
35.8%
38/106 • Number of events 54
|
29.4%
30/102 • Number of events 40
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.7%
6/106 • Number of events 7
|
2.9%
3/102 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.9%
2/106 • Number of events 2
|
5.9%
6/102 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
4/106 • Number of events 4
|
5.9%
6/102 • Number of events 7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
7.5%
8/106 • Number of events 11
|
3.9%
4/102 • Number of events 4
|
|
Nervous system disorders
Dizziness
|
3.8%
4/106 • Number of events 4
|
7.8%
8/102 • Number of events 8
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.7%
5/106 • Number of events 6
|
5.9%
6/102 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.5%
27/106 • Number of events 34
|
23.5%
24/102 • Number of events 30
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
29.2%
31/106 • Number of events 38
|
21.6%
22/102 • Number of events 25
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/106
|
17.6%
18/102 • Number of events 18
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.8%
21/106 • Number of events 31
|
3.9%
4/102 • Number of events 4
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60