Trial Outcomes & Findings for Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung Adenocarcinoma (NCT NCT01565538)
NCT ID: NCT01565538
Last Updated: 2014-09-15
Results Overview
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
123 participants
Primary outcome timeframe
From the date of randomization to the date of tumour progression or death from any cause, assessed until at least 12 months after randomization.
Results posted on
2014-09-15
Participant Flow
Participant milestones
| Measure |
Erlotinib
Erlotinib at the dose of 150 mg orally once a day continually until progression.
Erlotinib: 150 mg Given orally
|
Pemetrexed
Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.
Pemetrexed: 500mg/m2 Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
62
|
|
Overall Study
COMPLETED
|
61
|
62
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Erlotinib
n=61 Participants
Erlotinib at the dose of 150 mg orally once a day continually until progression.
Erlotinib: 150 mg Given orally
|
Pemetrexed
n=62 Participants
Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.
Pemetrexed: 500mg/m2 Given IV
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.3 years
n=5 Participants
|
55.1 years
n=7 Participants
|
54.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
ECOG PS
0,1
|
57 participants
n=5 Participants
|
59 participants
n=7 Participants
|
116 participants
n=5 Participants
|
|
ECOG PS
2
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Smoking status
Never
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Smoking status
Former
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Smoking status
Current
|
39 participants
n=5 Participants
|
40 participants
n=7 Participants
|
79 participants
n=5 Participants
|
|
Stage
IIIB
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Stage
IV
|
40 participants
n=5 Participants
|
38 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Stage
Recurrent
|
17 participants
n=5 Participants
|
18 participants
n=7 Participants
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization to the date of tumour progression or death from any cause, assessed until at least 12 months after randomization.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Erlotinib
n=61 Participants
Erlotinib at the dose of 150 mg orally once a day continually until progression.
Erlotinib: 150 mg Given orally
|
Pemetrexed
n=62 Participants
Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.
Pemetrexed: 500mg/m2 Given IV
|
|---|---|---|
|
Progression-Free Survival
|
4.1 months
Interval 1.6 to 6.6
|
3.9 months
Interval 2.7 to 5.1
|
SECONDARY outcome
Timeframe: From the date of randomization, assessed every 6 weeks, until at least 12 months after randomization.Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Erlotinib
n=61 Participants
Erlotinib at the dose of 150 mg orally once a day continually until progression.
Erlotinib: 150 mg Given orally
|
Pemetrexed
n=62 Participants
Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.
Pemetrexed: 500mg/m2 Given IV
|
|---|---|---|
|
Best Tumor Response
No objective response
|
49 participants
|
57 participants
|
|
Best Tumor Response
Objective response
|
12 participants
|
5 participants
|
SECONDARY outcome
Timeframe: From date of randomization until the date of death from any cause, assessed until at least 12 months after randomization.Outcome measures
| Measure |
Erlotinib
n=61 Participants
Erlotinib at the dose of 150 mg orally once a day continually until progression.
Erlotinib: 150 mg Given orally
|
Pemetrexed
n=62 Participants
Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.
Pemetrexed: 500mg/m2 Given IV
|
|---|---|---|
|
Overall Survival
|
11.7 months
Interval 7.5 to 15.9
|
13.4 months
Interval 9.2 to 17.7
|
Adverse Events
Erlotinib
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Pemetrexed
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Erlotinib
n=61 participants at risk
Erlotinib at the dose of 150 mg orally once a day continually until progression.
Erlotinib: 150 mg Given orally
|
Pemetrexed
n=62 participants at risk
Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.
Pemetrexed: 500mg/m2 Given IV
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
54.1%
33/61
|
6.5%
4/62
|
|
Gastrointestinal disorders
Diarrhea
|
16.4%
10/61
|
3.2%
2/62
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.9%
3/61
|
0.00%
0/62
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.9%
3/61
|
0.00%
0/62
|
|
Gastrointestinal disorders
Anorexia
|
9.8%
6/61
|
14.5%
9/62
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/61
|
24.2%
15/62
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/61
|
6.5%
4/62
|
|
General disorders
Fatigue
|
19.7%
12/61
|
25.8%
16/62
|
|
Infections and infestations
Infection
|
4.9%
3/61
|
1.6%
1/62
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/61
|
4.8%
3/62
|
|
Psychiatric disorders
Insomnia
|
6.6%
4/61
|
4.8%
3/62
|
|
Nervous system disorders
Headache
|
1.6%
1/61
|
4.8%
3/62
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/61
|
4.8%
3/62
|
|
Skin and subcutaneous tissue disorders
Paronychia
|
1.6%
1/61
|
0.00%
0/62
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place