Trial Outcomes & Findings for A Study for Patients With Non-Squamous Non-Small Cell Lung Cancer (NCT NCT00609518)
NCT ID: NCT00609518
Last Updated: 2010-12-28
Results Overview
Results are presented for the number of participants with drug-related Grade 3 or 4 toxicity/adverse event (AE). Grades range from 0 (none) to 5 (death), with Grade 3 and 4 being defined as follows: Grade 0 = No AE; Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. A detailed list of Serious and non-serious adverse events is provided in the Reported Adverse Event section.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
111 participants
Primary outcome timeframe
From first dose of treatment to last dose of treatment plus 30 days
Results posted on
2010-12-28
Participant Flow
Completed is defined as:The patient has completed follow-up visits until 12 months after the randomization date. Qualified Intent-to-Treat (Q-ITT) is defined as: Include all randomized patients, with nonsquamous histology, who comply with their pretreatment folic acid and steroid supplementation schedule and take at least one dose of pemetrexed.
Participant milestones
| Measure |
Standard Vitamin and Steroid Schedule + Pemetrexed
Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
|
Simplified Vitamin and Steroid Schedule + Pemetrexed
Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
57
|
|
Overall Study
Completed 6 Treatment Cycles
|
19
|
22
|
|
Overall Study
COMPLETED
|
11
|
17
|
|
Overall Study
NOT COMPLETED
|
43
|
40
|
Reasons for withdrawal
| Measure |
Standard Vitamin and Steroid Schedule + Pemetrexed
Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
|
Simplified Vitamin and Steroid Schedule + Pemetrexed
Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
|
|---|---|---|
|
Overall Study
Death from Study Disease
|
32
|
32
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Physician Decision
|
1
|
3
|
|
Overall Study
Death from Adverse Event
|
2
|
2
|
Baseline Characteristics
A Study for Patients With Non-Squamous Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Standard Vitamin and Steroid Schedule + Pemetrexed
n=54 Participants
Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
|
Simplified Vitamin and Steroid Schedule + Pemetrexed
n=57 Participants
Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
62.1 years
STANDARD_DEVIATION 11.08 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 12.13 • n=7 Participants
|
61.4 years
STANDARD_DEVIATION 11.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
27 participants
n=5 Participants
|
27 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
15 participants
n=5 Participants
|
18 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0- Fully Active
|
26 participants
n=5 Participants
|
26 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1- Ambulatory, Restricted Strenuous Activity
|
28 participants
n=5 Participants
|
28 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2- Ambulatory, No Work Activities
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Not Assessed
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Smoking Status
Past Smoker
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Smoking Status
Never Smoked
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Smoking Status
Current Smoker
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Pathological Diagnosis
Cytological
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Pathological Diagnosis
Histopathological
|
37 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Disease Stage
IIIA
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Disease Stage
IIIB
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Disease Stage
IV
|
42 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
25.3 kg/m^2
STANDARD_DEVIATION 3.98 • n=5 Participants
|
26.0 kg/m^2
STANDARD_DEVIATION 5.20 • n=7 Participants
|
25.7 kg/m^2
STANDARD_DEVIATION 4.64 • n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of treatment to last dose of treatment plus 30 daysPopulation: Qualified Intention to Treat (Q-ITT)
Results are presented for the number of participants with drug-related Grade 3 or 4 toxicity/adverse event (AE). Grades range from 0 (none) to 5 (death), with Grade 3 and 4 being defined as follows: Grade 0 = No AE; Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. A detailed list of Serious and non-serious adverse events is provided in the Reported Adverse Event section.
Outcome measures
| Measure |
Standard Vitamin and Steroid Schedule + Pemetrexed
n=51 Participants
Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
|
Simplified Vitamin and Steroid Schedule + Pemetrexed
n=47 Participants
Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
|
|---|---|---|
|
Safety: Number of Participants With Drug-Related Grade 3 or 4 Toxicity
|
15 participants
|
18 participants
|
SECONDARY outcome
Timeframe: Baseline until disease progression, new therapy initiated, or death from any cause, up to 12 months after enrollment.Population: Qualified Intent to Treat (Q-ITT)
Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Best Overall Tumor Response is complete response plus partial response.
Outcome measures
| Measure |
Standard Vitamin and Steroid Schedule + Pemetrexed
n=51 Participants
Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
|
Simplified Vitamin and Steroid Schedule + Pemetrexed
n=47 Participants
Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
|
|---|---|---|
|
Proportion of Participants With Best Overall Tumor Response (Response Rate)
|
0.118 proportion of patients
Interval 0.044 to 0.239
|
0.064 proportion of patients
Interval 0.013 to 0.175
|
SECONDARY outcome
Timeframe: Randomization (≤4 weeks from baseline visit) to 12 months after randomizationPopulation: Qualified Intent to Treat (Q-ITT)
Overall survival is the duration from randomization to death. For patients who are alive, overall survival is censored at the date of last contact.
Outcome measures
| Measure |
Standard Vitamin and Steroid Schedule + Pemetrexed
n=51 Participants
Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
|
Simplified Vitamin and Steroid Schedule + Pemetrexed
n=47 Participants
Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
|
|---|---|---|
|
Overall Survival
|
8.2 months
Interval 5.4 to 11.7
|
9.2 months
Interval 7.6 to 11.3
|
SECONDARY outcome
Timeframe: Randomization (≤4 weeks from baseline visit) to 12 months after randomizationPopulation: Qualified Intent to Treat (Q-ITT)
Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. For patients who are alive and have not progressed, PFS is censored at the date of last radiological assessment.
Outcome measures
| Measure |
Standard Vitamin and Steroid Schedule + Pemetrexed
n=51 Participants
Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
|
Simplified Vitamin and Steroid Schedule + Pemetrexed
n=47 Participants
Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
3.7 months
Interval 2.9 to 4.9
|
3.8 months
Interval 1.8 to 5.9
|
Adverse Events
Standard Vitamin and Steroid Schedule + Pemetrexed
Serious events: 18 serious events
Other events: 47 other events
Deaths: 0 deaths
Simplified Vitamin and Steroid Schedule + Pemetrexed
Serious events: 18 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Vitamin and Steroid Schedule + Pemetrexed
n=54 participants at risk
Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
|
Simplified Vitamin and Steroid Schedule + Pemetrexed
n=57 participants at risk
Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.7%
2/54 • Number of events 2
|
1.8%
1/57 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/54
|
3.5%
2/57 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/54
|
1.8%
1/57 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/54
|
1.8%
1/57 • Number of events 1
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/54
|
1.8%
1/57 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.9%
1/54 • Number of events 1
|
0.00%
0/57
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
1/54 • Number of events 1
|
0.00%
0/57
|
|
Cardiac disorders
Cardiac failure congestive
|
1.9%
1/54 • Number of events 1
|
0.00%
0/57
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/54
|
1.8%
1/57 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/54 • Number of events 2
|
0.00%
0/57
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/54
|
1.8%
1/57 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/54
|
1.8%
1/57 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/54
|
1.8%
1/57 • Number of events 1
|
|
General disorders
Chest pain
|
0.00%
0/54
|
3.5%
2/57 • Number of events 2
|
|
General disorders
Oedema peripheral
|
1.9%
1/54 • Number of events 1
|
0.00%
0/57
|
|
General disorders
Pyrexia
|
0.00%
0/54
|
1.8%
1/57 • Number of events 1
|
|
Infections and infestations
Bronchiectasis
|
0.00%
0/54
|
1.8%
1/57 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/54
|
1.8%
1/57 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
1.9%
1/54 • Number of events 1
|
0.00%
0/57
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/54
|
1.8%
1/57 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
3.7%
2/54 • Number of events 2
|
1.8%
1/57 • Number of events 1
|
|
Infections and infestations
Respiratory tract infection
|
1.9%
1/54 • Number of events 1
|
0.00%
0/57
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/54
|
1.8%
1/57 • Number of events 1
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.9%
1/54 • Number of events 1
|
0.00%
0/57
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/54
|
3.5%
2/57 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.9%
1/54 • Number of events 1
|
0.00%
0/57
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.9%
1/54 • Number of events 1
|
1.8%
1/57 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.9%
1/54 • Number of events 1
|
0.00%
0/57
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/54
|
1.8%
1/57 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/54
|
1.8%
1/57 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
1.9%
1/54 • Number of events 1
|
0.00%
0/57
|
|
Nervous system disorders
Ataxia
|
0.00%
0/54
|
1.8%
1/57 • Number of events 1
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.00%
0/54
|
1.8%
1/57 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
1.9%
1/54 • Number of events 1
|
1.8%
1/57 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/54
|
1.8%
1/57 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
3/54 • Number of events 3
|
1.8%
1/57 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
3.7%
2/54 • Number of events 2
|
0.00%
0/57
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.9%
1/54 • Number of events 1
|
0.00%
0/57
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
1.9%
1/54 • Number of events 1
|
0.00%
0/57
|
|
Respiratory, thoracic and mediastinal disorders
Oesophagobronchial fistula
|
0.00%
0/54
|
1.8%
1/57 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.7%
2/54 • Number of events 2
|
3.5%
2/57 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/54
|
1.8%
1/57 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.9%
1/54 • Number of events 1
|
1.8%
1/57 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.9%
1/54 • Number of events 1
|
1.8%
1/57 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.9%
1/54 • Number of events 1
|
1.8%
1/57 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
1.9%
1/54 • Number of events 1
|
0.00%
0/57
|
Other adverse events
| Measure |
Standard Vitamin and Steroid Schedule + Pemetrexed
n=54 participants at risk
Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
|
Simplified Vitamin and Steroid Schedule + Pemetrexed
n=57 participants at risk
Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
24.1%
13/54 • Number of events 17
|
31.6%
18/57 • Number of events 24
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.8%
8/54 • Number of events 13
|
31.6%
18/57 • Number of events 36
|
|
Blood and lymphatic system disorders
Lymphopenia
|
16.7%
9/54 • Number of events 9
|
26.3%
15/57 • Number of events 20
|
|
Blood and lymphatic system disorders
Neutropenia
|
24.1%
13/54 • Number of events 21
|
29.8%
17/57 • Number of events 31
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.0%
7/54 • Number of events 9
|
12.3%
7/57 • Number of events 8
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
3/54 • Number of events 3
|
3.5%
2/57 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
5.6%
3/54 • Number of events 3
|
7.0%
4/57 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
2/54 • Number of events 2
|
7.0%
4/57 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
20.4%
11/54 • Number of events 15
|
33.3%
19/57 • Number of events 21
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
6/54 • Number of events 10
|
14.0%
8/57 • Number of events 8
|
|
General disorders
Asthenia
|
25.9%
14/54 • Number of events 16
|
24.6%
14/57 • Number of events 14
|
|
General disorders
Chest pain
|
7.4%
4/54 • Number of events 4
|
3.5%
2/57 • Number of events 2
|
|
General disorders
Fatigue
|
11.1%
6/54 • Number of events 7
|
12.3%
7/57 • Number of events 9
|
|
General disorders
Pyrexia
|
0.00%
0/54
|
10.5%
6/57 • Number of events 9
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/54
|
5.3%
3/57 • Number of events 3
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
6/54 • Number of events 10
|
15.8%
9/57 • Number of events 15
|
|
Investigations
Aspartate aminotransferase increased
|
3.7%
2/54 • Number of events 4
|
10.5%
6/57 • Number of events 11
|
|
Investigations
Blood alkaline phosphatase increased
|
5.6%
3/54 • Number of events 3
|
8.8%
5/57 • Number of events 7
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/54
|
5.3%
3/57 • Number of events 3
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.9%
1/54 • Number of events 2
|
14.0%
8/57 • Number of events 8
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.4%
4/54 • Number of events 4
|
10.5%
6/57 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.4%
4/54 • Number of events 5
|
14.0%
8/57 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/54
|
5.3%
3/57 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.9%
1/54 • Number of events 1
|
5.3%
3/57 • Number of events 3
|
|
Nervous system disorders
Headache
|
5.6%
3/54 • Number of events 3
|
1.8%
1/57 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.8%
8/54 • Number of events 9
|
19.3%
11/57 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.0%
7/54 • Number of events 8
|
19.3%
11/57 • Number of events 13
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.8%
8/54 • Number of events 8
|
12.3%
7/57 • Number of events 9
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60