Trial Outcomes & Findings for Study of Pemetrexed Versus Pemetrexed Plus Erlotinib as Treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (NCT NCT00447057)
NCT ID: NCT00447057
Last Updated: 2011-10-13
Results Overview
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria using computed tomography (CT) or magnetic resonance imaging (MRI) for objective determination of progressive disease (PD: ≤20% increase in sum of longest diameter of target lesion). For participants alive as of data cut-off date who did not have PD, PFS was censored at date of last CT/MRI. For participants who received subsequent systemic anticancer therapy (after study discontinuation) prior to PD or death, PFS censored at date of last CT/MRI prior to initiation of post discontinuation systemic anticancer therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
204 participants
Primary outcome timeframe
Baseline to date of measured PD or death from any cause. Maximum follow-up was from baseline to 32.2 months
Results posted on
2011-10-13
Participant Flow
This is a 2-arm study; however, results for participant disposition and baseline characteristics are presented for 4 groups including each study arm (Pemetrexed and Pemetrexed + Erlotinib) by histology (Nonsquamous and Squamous). Efficacy results are presented for participants with nonsquamous histology only.
Participant milestones
| Measure |
Pemetrexed (Nonsquamous)
Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression or unacceptable toxicity
|
Pemetrexed + Erlotinib (Nonsquamous)
Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Erlotinib: 150 mg given orally (po), daily (QD), starting on the first day of the first cycle
|
Pemetrexed (Squamous)
Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
|
Pemetrexed + Erlotinib (Squamous)
Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Erlotinib: 150 mg given po, QD, starting on the first day of the first cycle
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
83
|
76
|
19
|
26
|
|
Overall Study
COMPLETED
|
0
|
3
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
83
|
73
|
19
|
26
|
Reasons for withdrawal
| Measure |
Pemetrexed (Nonsquamous)
Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression or unacceptable toxicity
|
Pemetrexed + Erlotinib (Nonsquamous)
Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Erlotinib: 150 mg given orally (po), daily (QD), starting on the first day of the first cycle
|
Pemetrexed (Squamous)
Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
|
Pemetrexed + Erlotinib (Squamous)
Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Erlotinib: 150 mg given po, QD, starting on the first day of the first cycle
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
10
|
0
|
3
|
|
Overall Study
Death due to study disease
|
6
|
4
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Entry criteria not met
|
1
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
1
|
1
|
|
Overall Study
Physician Decision
|
9
|
6
|
3
|
1
|
|
Overall Study
Sponsor decision
|
1
|
1
|
0
|
0
|
|
Overall Study
Progressive disease
|
58
|
43
|
13
|
18
|
|
Overall Study
Death due to adverse event
|
0
|
0
|
1
|
2
|
|
Overall Study
Death, study drug related
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study of Pemetrexed Versus Pemetrexed Plus Erlotinib as Treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Pemetrexed (Nonsquamous)
n=83 Participants
Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity
|
Pemetrexed + Erlotinib (Nonsquamous)
n=76 Participants
Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity
Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle
|
Pemetrexed (Squamous)
n=19 Participants
Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
|
Pemetrexed + Erlotinib (Squamous)
n=26 Participants
Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity
Erlotinib: 150 mg given po, QD, starting on the first day of the first cycle
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
59.8 years
STANDARD_DEVIATION 10.25 • n=5 Participants
|
63.5 years
STANDARD_DEVIATION 9.70 • n=7 Participants
|
63.9 years
STANDARD_DEVIATION 9.33 • n=5 Participants
|
66.1 years
STANDARD_DEVIATION 8.58 • n=4 Participants
|
62.3 years
STANDARD_DEVIATION 9.96 • n=21 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
138 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
82 participants
n=5 Participants
|
75 participants
n=7 Participants
|
19 participants
n=5 Participants
|
26 participants
n=4 Participants
|
202 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
West Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Region of Enrollment
Austria
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
11 participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
44 participants
n=5 Participants
|
37 participants
n=7 Participants
|
6 participants
n=5 Participants
|
15 participants
n=4 Participants
|
102 participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
18 participants
n=5 Participants
|
9 participants
n=7 Participants
|
7 participants
n=5 Participants
|
7 participants
n=4 Participants
|
41 participants
n=21 Participants
|
|
Region of Enrollment
Hungary
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
34 participants
n=21 Participants
|
|
Region of Enrollment
Sweden
|
5 participants
n=5 Participants
|
11 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
16 participants
n=21 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Status 0
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Status 1
|
39 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Status 2
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Basis for Diagnosis
Histopathological
|
64 participants
n=5 Participants
|
61 participants
n=7 Participants
|
18 participants
n=5 Participants
|
22 participants
n=4 Participants
|
165 participants
n=21 Participants
|
|
Basis for Diagnosis
Cytological
|
19 participants
n=5 Participants
|
15 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
39 participants
n=21 Participants
|
|
Initial Pathological Diagnosis
Adenocarcinoma of the lung
|
70 participants
n=5 Participants
|
61 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
131 participants
n=21 Participants
|
|
Initial Pathological Diagnosis
Mixed cell (squamous/adenocarcinoma)
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Initial Pathological Diagnosis
Large cell lung carcinoma
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
15 participants
n=21 Participants
|
|
Initial Pathological Diagnosis
Bronchioalveolar carcinoma
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Initial Pathological Diagnosis
Squamous cell carcinoma of the lung
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
19 participants
n=5 Participants
|
26 participants
n=4 Participants
|
45 participants
n=21 Participants
|
|
Initial Pathological Diagnosis
Unknown
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Stage of Disease at Study Entry
Stage I
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Stage of Disease at Study Entry
Stage II
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Stage of Disease at Study Entry
Stage IIIA
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Stage of Disease at Study Entry
Stage IIIB
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
4 participants
n=5 Participants
|
5 participants
n=4 Participants
|
30 participants
n=21 Participants
|
|
Stage of Disease at Study Entry
Stage IV
|
70 participants
n=5 Participants
|
64 participants
n=7 Participants
|
13 participants
n=5 Participants
|
21 participants
n=4 Participants
|
168 participants
n=21 Participants
|
|
Smoking status
Never smoked
|
14 participants
n=5 Participants
|
10 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
24 participants
n=21 Participants
|
|
Smoking status
Ex-smoker
|
44 participants
n=5 Participants
|
51 participants
n=7 Participants
|
12 participants
n=5 Participants
|
19 participants
n=4 Participants
|
126 participants
n=21 Participants
|
|
Smoking status
Current smoker
|
25 participants
n=5 Participants
|
15 participants
n=7 Participants
|
7 participants
n=5 Participants
|
7 participants
n=4 Participants
|
54 participants
n=21 Participants
|
|
Pack-years, smokers only
Up to 15 pack-years
|
5 participants
n=5 Participants
|
13 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
20 participants
n=21 Participants
|
|
Pack-years, smokers only
More than 15 pack-years
|
60 participants
n=5 Participants
|
48 participants
n=7 Participants
|
15 participants
n=5 Participants
|
25 participants
n=4 Participants
|
148 participants
n=21 Participants
|
|
Pack-years, smokers only
Unknown
|
18 participants
n=5 Participants
|
15 participants
n=7 Participants
|
3 participants
n=5 Participants
|
0 participants
n=4 Participants
|
36 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to date of measured PD or death from any cause. Maximum follow-up was from baseline to 32.2 monthsPopulation: Includes Nonsquamous population only. In Pemetrexed arm, 13 (15.7%) participants censored overall: 12 (14.5%) because of receiving subsequent systemic anticancer therapy. In Pemetrexed + Erlotinib arm, 16 (21.1%) participants censored overall: 9 (11.8%) because of receiving subsequent systemic anticancer therapy.
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria using computed tomography (CT) or magnetic resonance imaging (MRI) for objective determination of progressive disease (PD: ≤20% increase in sum of longest diameter of target lesion). For participants alive as of data cut-off date who did not have PD, PFS was censored at date of last CT/MRI. For participants who received subsequent systemic anticancer therapy (after study discontinuation) prior to PD or death, PFS censored at date of last CT/MRI prior to initiation of post discontinuation systemic anticancer therapy.
Outcome measures
| Measure |
Pemetrexed (Nonsquamous)
n=70 Participants
Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
|
Pemetrexed + Erlotinib (Nonsquamous)
n=60 Participants
Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle
|
|---|---|---|
|
Progression Free Survival (PFS)
|
2.9 months
Interval 1.94 to 3.38
|
3.2 months
Interval 2.86 to 4.7
|
SECONDARY outcome
Timeframe: Baseline to measured PD. Maximum follow-up was from Baseline to 34 monthsPopulation: Includes nonsquamous population only.
Per RECIST: CR: Disappearance of all target lesions; PR: Either a) ≤30% decrease in sum of longest diameter (LD) of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) of ≥1 nontarget lesions. In either case, no new lesions may have appeared. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD. PD: ≤20% increase in sum of LD of target lesions. Disease Control Rate (%) = (SD+PR+CR)/number of participants in arm\*100.
Outcome measures
| Measure |
Pemetrexed (Nonsquamous)
n=83 Participants
Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
|
Pemetrexed + Erlotinib (Nonsquamous)
n=76 Participants
Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle
|
|---|---|---|
|
Percentage of Participants With Best Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Disease Control Rate)
|
51.8 percentage of participants
Interval 40.6 to 62.9
|
55.3 percentage of participants
Interval 43.4 to 66.7
|
SECONDARY outcome
Timeframe: Baseline to measured progressive disease. Maximum follow-up was from Baseline to 34 monthsPopulation: Includes nonsquamous population only.
CR: Disappearance of all tumor lesions; PR: Either a) at least a 30% decrease in sum of LD of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) ≥1 nontarget lesions. In either case, no new lesions may have appeared. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD. PD: ≤20% increase in the sum of LD of target lesions. Response Rate (%) = (CR+PR)/number of participants in arm\*100.
Outcome measures
| Measure |
Pemetrexed (Nonsquamous)
n=83 Participants
Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
|
Pemetrexed + Erlotinib (Nonsquamous)
n=76 Participants
Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle
|
|---|---|---|
|
Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) (Response Rate)
|
10.8 percentage of participants
Interval 5.1 to 19.6
|
17.1 percentage of participants
Interval 9.4 to 27.5
|
SECONDARY outcome
Timeframe: Baseline to first date among death from any cause, PD, or study treatment discontinuation for any reason other than "protocol complete" or "satisfactory response". Maximum follow-up was from Baseline to 32.2 monthsPopulation: Includes nonsquamous population only.
Defined as the time from randomization to death from any cause, first observation of PD, or study treatment discontinuation due to any reason other than "protocol complete" or "satisfactory response". For participants who discontinued due to "protocol complete" or "satisfactory response", or for participants not known to have discontinued as of the data cut-off date, TTTF was censored at the last contact date.
Outcome measures
| Measure |
Pemetrexed (Nonsquamous)
n=83 Participants
Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
|
Pemetrexed + Erlotinib (Nonsquamous)
n=73 Participants
Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle
|
|---|---|---|
|
Time to Treatment Failure (TTTF)
|
2.4 months
Interval 1.74 to 2.99
|
3.0 months
Interval 2.23 to 4.07
|
SECONDARY outcome
Timeframe: Baseline to date of death from any cause. Maximum follow-up was from Baseline to 42.6 months.Population: Pemetrexed arm: 17 (20.5%) participants censored Pemetrexed + Erlotinib arm: 28 (36.8%) participants censored
OS time is the duration from randomization to the date of death from any cause. For each participant who was not known to have died as of the data inclusion cut-off date, OS was censored at the date of last contact.
Outcome measures
| Measure |
Pemetrexed (Nonsquamous)
n=66 Participants
Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
|
Pemetrexed + Erlotinib (Nonsquamous)
n=48 Participants
Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle
|
|---|---|---|
|
Overall Survival (OS)
|
7.8 months
Interval 5.29 to 10.41
|
11.8 months
Interval 8.18 to 16.66
|
SECONDARY outcome
Timeframe: Baseline to date of death from any cause up to 1 yearPopulation: Includes nonsquamous population only. On the Pemetrexed arm, 17 participants were censored overall and on the Pemetrexed + Erlotinib arm, 28 participants were censored overall.
Overall Survival (OS) rate at 1 year from the date of randomization was determined using the distribution of OS times and was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Pemetrexed (Nonsquamous)
n=66 Participants
Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
|
Pemetrexed + Erlotinib (Nonsquamous)
n=48 Participants
Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle
|
|---|---|---|
|
Percentage of Participants Surviving at 1 Year
|
34.1 Percentage participants with OS ≥1 year
Interval 23.82 to 44.56
|
49.4 Percentage participants with OS ≥1 year
Interval 37.25 to 60.36
|
SECONDARY outcome
Timeframe: Baseline up to 42.2 monthsPopulation: All participants who received at least 1 dose of study drug were analyzed for safety. Nonsquamous and squamous populations are combined.
Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.
Outcome measures
| Measure |
Pemetrexed (Nonsquamous)
n=102 Participants
Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
|
Pemetrexed + Erlotinib (Nonsquamous)
n=102 Participants
Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
serious adverse events
|
43 participants
|
53 participants
|
|
Number of Participants With Adverse Events (AEs)
other adverse events
|
91 participants
|
98 participants
|
Adverse Events
Pemetrexed (Nonsquamous and Squamous)
Serious events: 43 serious events
Other events: 91 other events
Deaths: 0 deaths
Pemetrexed + Erlotinib (Nonsquamous and Squamous)
Serious events: 53 serious events
Other events: 98 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed (Nonsquamous and Squamous)
n=102 participants at risk
Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
|
Pemetrexed + Erlotinib (Nonsquamous and Squamous)
n=102 participants at risk
Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.9%
4/102 • Number of events 4
|
9.8%
10/102 • Number of events 10
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.0%
2/102 • Number of events 2
|
9.8%
10/102 • Number of events 10
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.98%
1/102 • Number of events 1
|
2.9%
3/102 • Number of events 3
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.9%
3/102 • Number of events 3
|
4.9%
5/102 • Number of events 5
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.9%
3/102 • Number of events 3
|
6.9%
7/102 • Number of events 8
|
|
Cardiac disorders
Atrial fibrillation
|
0.98%
1/102 • Number of events 1
|
0.00%
0/102
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.98%
1/102 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
2/102 • Number of events 2
|
0.00%
0/102
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/102
|
2.9%
3/102 • Number of events 4
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.0%
2/102 • Number of events 2
|
0.00%
0/102
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.98%
1/102 • Number of events 1
|
0.00%
0/102
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
2.0%
2/102 • Number of events 2
|
2.0%
2/102 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
0.98%
1/102 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
General disorders
Chest pain
|
0.98%
1/102 • Number of events 1
|
0.00%
0/102
|
|
General disorders
Fatigue
|
0.98%
1/102 • Number of events 1
|
2.0%
2/102 • Number of events 2
|
|
General disorders
General physical health deterioration
|
2.0%
2/102 • Number of events 2
|
8.8%
9/102 • Number of events 9
|
|
General disorders
Pain
|
2.0%
2/102 • Number of events 2
|
0.00%
0/102
|
|
General disorders
Performance status decreased
|
0.98%
1/102 • Number of events 1
|
0.00%
0/102
|
|
General disorders
Pyrexia
|
2.0%
2/102 • Number of events 5
|
2.0%
2/102 • Number of events 3
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.98%
1/102 • Number of events 1
|
2.9%
3/102 • Number of events 3
|
|
Infections and infestations
Candida pneumonia
|
0.98%
1/102 • Number of events 1
|
0.00%
0/102
|
|
Infections and infestations
Cystitis
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Infections and infestations
Infection
|
2.0%
2/102 • Number of events 4
|
0.00%
0/102
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Infections and infestations
Lung abscess
|
0.98%
1/102 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Infections and infestations
Lung infection
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
2.9%
3/102 • Number of events 3
|
3.9%
4/102 • Number of events 4
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Infections and infestations
Pyothorax
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Infections and infestations
Respiratory tract infection
|
2.0%
2/102 • Number of events 2
|
0.00%
0/102
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
2.0%
2/102 • Number of events 3
|
0.00%
0/102
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Investigations
C-reactive protein increased
|
0.98%
1/102 • Number of events 1
|
0.00%
0/102
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.0%
2/102 • Number of events 2
|
0.00%
0/102
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.98%
1/102 • Number of events 1
|
0.00%
0/102
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.98%
1/102 • Number of events 1
|
0.00%
0/102
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.98%
1/102 • Number of events 1
|
0.00%
0/102
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.98%
1/102 • Number of events 1
|
0.00%
0/102
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.98%
1/102 • Number of events 1
|
2.0%
2/102 • Number of events 2
|
|
Nervous system disorders
Carotid artery stenosis
|
0.98%
1/102 • Number of events 1
|
0.00%
0/102
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/102
|
2.0%
2/102 • Number of events 2
|
|
Nervous system disorders
Convulsion
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.98%
1/102 • Number of events 1
|
0.00%
0/102
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.98%
1/102 • Number of events 1
|
0.00%
0/102
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
0.98%
1/102 • Number of events 1
|
0.00%
0/102
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Psychiatric disorders
Panic attack
|
2.0%
2/102 • Number of events 2
|
0.00%
0/102
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/102
|
2.0%
2/102 • Number of events 2
|
|
Renal and urinary disorders
Renal impairment
|
0.98%
1/102 • Number of events 1
|
0.00%
0/102
|
|
Renal and urinary disorders
Urinary retention
|
0.98%
1/102 • Number of events 1
|
0.00%
0/102
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.98%
1/102 • Number of events 1
|
0.00%
0/102
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.98%
1/102 • Number of events 1
|
2.0%
2/102 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.98%
1/102 • Number of events 1
|
0.00%
0/102
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.98%
1/102 • Number of events 1
|
0.00%
0/102
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.9%
3/102 • Number of events 3
|
0.98%
1/102 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.98%
1/102 • Number of events 1
|
0.00%
0/102
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.98%
1/102 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.98%
1/102 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.98%
1/102 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
2/102 • Number of events 2
|
2.0%
2/102 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/102
|
2.0%
2/102 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.98%
1/102 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/102
|
0.98%
1/102 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.98%
1/102 • Number of events 1
|
0.00%
0/102
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.98%
1/102 • Number of events 1
|
0.00%
0/102
|
|
Vascular disorders
Superior vena caval occlusion
|
0.98%
1/102 • Number of events 1
|
0.00%
0/102
|
Other adverse events
| Measure |
Pemetrexed (Nonsquamous and Squamous)
n=102 participants at risk
Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
|
Pemetrexed + Erlotinib (Nonsquamous and Squamous)
n=102 participants at risk
Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
21.6%
22/102 • Number of events 26
|
25.5%
26/102 • Number of events 31
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.8%
9/102 • Number of events 20
|
28.4%
29/102 • Number of events 69
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.9%
5/102 • Number of events 6
|
6.9%
7/102 • Number of events 14
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.7%
14/102 • Number of events 24
|
27.5%
28/102 • Number of events 69
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.9%
5/102 • Number of events 9
|
17.6%
18/102 • Number of events 28
|
|
Gastrointestinal disorders
Abdominal pain
|
4.9%
5/102 • Number of events 6
|
5.9%
6/102 • Number of events 6
|
|
Gastrointestinal disorders
Constipation
|
11.8%
12/102 • Number of events 12
|
5.9%
6/102 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhoea
|
7.8%
8/102 • Number of events 8
|
43.1%
44/102 • Number of events 60
|
|
Gastrointestinal disorders
Nausea
|
23.5%
24/102 • Number of events 30
|
31.4%
32/102 • Number of events 43
|
|
Gastrointestinal disorders
Stomatitis
|
4.9%
5/102 • Number of events 6
|
12.7%
13/102 • Number of events 14
|
|
Gastrointestinal disorders
Vomiting
|
8.8%
9/102 • Number of events 13
|
14.7%
15/102 • Number of events 19
|
|
General disorders
Asthenia
|
15.7%
16/102 • Number of events 23
|
16.7%
17/102 • Number of events 20
|
|
General disorders
Chest pain
|
5.9%
6/102 • Number of events 6
|
4.9%
5/102 • Number of events 6
|
|
General disorders
Fatigue
|
18.6%
19/102 • Number of events 24
|
21.6%
22/102 • Number of events 27
|
|
General disorders
Oedema peripheral
|
7.8%
8/102 • Number of events 8
|
7.8%
8/102 • Number of events 9
|
|
General disorders
Pyrexia
|
9.8%
10/102 • Number of events 12
|
16.7%
17/102 • Number of events 21
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
6/102 • Number of events 7
|
2.9%
3/102 • Number of events 3
|
|
Investigations
Alanine aminotransferase increased
|
4.9%
5/102 • Number of events 6
|
16.7%
17/102 • Number of events 21
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
6/102 • Number of events 6
|
9.8%
10/102 • Number of events 14
|
|
Investigations
Blood creatinine increased
|
4.9%
5/102 • Number of events 7
|
5.9%
6/102 • Number of events 6
|
|
Investigations
Haemoglobin decreased
|
5.9%
6/102 • Number of events 6
|
9.8%
10/102 • Number of events 13
|
|
Investigations
Weight decreased
|
19.6%
20/102 • Number of events 20
|
26.5%
27/102 • Number of events 27
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.7%
13/102 • Number of events 15
|
30.4%
31/102 • Number of events 33
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.9%
3/102 • Number of events 3
|
9.8%
10/102 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.9%
4/102 • Number of events 4
|
5.9%
6/102 • Number of events 7
|
|
Nervous system disorders
Dizziness
|
11.8%
12/102 • Number of events 12
|
11.8%
12/102 • Number of events 12
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/102
|
5.9%
6/102 • Number of events 6
|
|
Nervous system disorders
Headache
|
5.9%
6/102 • Number of events 6
|
5.9%
6/102 • Number of events 6
|
|
Nervous system disorders
Polyneuropathy
|
2.0%
2/102 • Number of events 2
|
8.8%
9/102 • Number of events 9
|
|
Psychiatric disorders
Insomnia
|
3.9%
4/102 • Number of events 4
|
5.9%
6/102 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.8%
12/102 • Number of events 13
|
13.7%
14/102 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
24.5%
25/102 • Number of events 26
|
17.6%
18/102 • Number of events 19
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/102
|
7.8%
8/102 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/102
|
13.7%
14/102 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.98%
1/102 • Number of events 1
|
8.8%
9/102 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
6/102 • Number of events 7
|
6.9%
7/102 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.8%
9/102 • Number of events 25
|
42.2%
43/102 • Number of events 48
|
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