Trial Outcomes & Findings for Pemetrexed Disodium With or Without Erlotinib Hydrochloride in Treating Patients With Stage IIIB-IV or Recurrent Non-Small Cell Lung Cancer (NCT NCT00950365)
NCT ID: NCT00950365
Last Updated: 2020-09-16
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
79 participants
Primary outcome timeframe
Time from randomization until documented tumor progression or death from any cause, assessed up to 12 months
Results posted on
2020-09-16
Participant Flow
Patients with platinum-treated metastatic non squamous NSCLC randomly assigned 1:2 to pemetrexed alone (500 mg/m\^2 provided iv on day 1) or pemetrexed followed by erlotinib (150 mg provided orally daily on days 2-17) every 21 days.
Participant milestones
| Measure |
Arm A (Pemetrexed)
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
|
Arm B (Pemetrexed Disodium, Erlotinib Hydrochloride)
Patients receive pemetrexed disodium IV as in Arm A and erlotinib hydrochloride PO QD on days 2-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Erlotinib Hydrochloride: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
52
|
|
Overall Study
COMPLETED
|
25
|
50
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pemetrexed Disodium With or Without Erlotinib Hydrochloride in Treating Patients With Stage IIIB-IV or Recurrent Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm A (Pemetrexed)
n=27 Participants
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
|
Arm B (Pemetrexed Disodium, Erlotinib Hydrochloride)
n=52 Participants
Patients receive pemetrexed disodium IV as in Arm A and erlotinib hydrochloride PO QD on days 2-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Erlotinib Hydrochloride: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
62 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
18 participants
n=5 Participants
|
36 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 participants
n=5 Participants
|
9 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Smoking history
<=15 pack-years
|
5 participants
n=5 Participants
|
17 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Smoking history
>15 pack-years
|
22 participants
n=5 Participants
|
35 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
ECOG PS
ECOG PS 0
|
24 participants
n=5 Participants
|
46 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
ECOG PS
ECOG PS 1/2
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Histology: Nonsquamous
Prior platinum-containing chemotherapy
|
27 participants
n=5 Participants
|
50 participants
n=7 Participants
|
77 participants
n=5 Participants
|
|
Histology: Nonsquamous
Prior antiangiogenic inhibitor
|
10 participants
n=5 Participants
|
18 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Evaluable patients with atleast one source of biospecimen
Archival tumor specimens
|
6 participants
n=5 Participants
|
14 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Evaluable patients with atleast one source of biospecimen
Collected blood samples
|
17 participants
n=5 Participants
|
32 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Evaluable patients with atleast one source of biospecimen
EGFR (epidermal growth factor receptor) wild type
|
21 participants
n=5 Participants
|
31 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Evaluable patients with atleast one source of biospecimen
EGFR (epidermal growth factor receptor) mutations
|
0 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Evaluable patients with atleast one source of biospecimen
Unkown EGFR (epidermal growth factor recep) status
|
4 participants
n=5 Participants
|
12 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from randomization until documented tumor progression or death from any cause, assessed up to 12 monthsProgression 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 |
Arm A (Pemetrexed)
n=25 Participants
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
|
Arm B (Pemetrexed Disodium, Erlotinib Hydrochloride)
n=50 Participants
Patients receive pemetrexed disodium IV as in Arm A and erlotinib hydrochloride PO QD on days 2-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Erlotinib Hydrochloride: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
|
|---|---|---|
|
PFS (Progression Free Survival)
|
8 months
Interval 0.0 to 19.0
|
20 months
Interval 7.0 to 29.0
|
SECONDARY outcome
Timeframe: Up to 12 monthsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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 Response rates in each arm will be summarized by computing proportions and corresponding 95% confidence intervals.
Outcome measures
| Measure |
Arm A (Pemetrexed)
n=25 Participants
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
|
Arm B (Pemetrexed Disodium, Erlotinib Hydrochloride)
n=50 Participants
Patients receive pemetrexed disodium IV as in Arm A and erlotinib hydrochloride PO QD on days 2-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Erlotinib Hydrochloride: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
|
|---|---|---|
|
Objective Response Rate (CR +PR) Evaluated Using RECIST
|
12 percentage of participants
Interval 0.0 to 25.0
|
28 percentage of participants
Interval 10.0 to 40.0
|
SECONDARY outcome
Timeframe: Time from the date of randomization to date of death due to any cause, assessed up to 12 monthsTime to event endpoints will be analyzed using standard survival analytic methods, including the Kaplan-Meier approach for estimating the survival distributions.
Outcome measures
| Measure |
Arm A (Pemetrexed)
n=25 Participants
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
|
Arm B (Pemetrexed Disodium, Erlotinib Hydrochloride)
n=50 Participants
Patients receive pemetrexed disodium IV as in Arm A and erlotinib hydrochloride PO QD on days 2-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Erlotinib Hydrochloride: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
|
|---|---|---|
|
Overall Survival
|
25 Participants
|
50 Participants
|
Adverse Events
Arm A (Pemetrexed)
Serious events: 9 serious events
Other events: 25 other events
Deaths: 0 deaths
Arm B (Pemetrexed Disodium, Erlotinib Hydrochloride)
Serious events: 16 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Pemetrexed)
n=25 participants at risk
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
|
Arm B (Pemetrexed Disodium, Erlotinib Hydrochloride)
n=50 participants at risk
Patients receive pemetrexed disodium IV as in Arm A and erlotinib hydrochloride PO QD on days 2-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Erlotinib Hydrochloride: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
8.0%
2/25 • Number of events 2 • 3 years
|
10.0%
5/50 • Number of events 5 • 3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
28.0%
7/25 • Number of events 7 • 3 years
|
20.0%
10/50 • Number of events 10 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Insterstitial lung disease
|
0.00%
0/25 • 3 years
|
2.0%
1/50 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Arm A (Pemetrexed)
n=25 participants at risk
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
|
Arm B (Pemetrexed Disodium, Erlotinib Hydrochloride)
n=50 participants at risk
Patients receive pemetrexed disodium IV as in Arm A and erlotinib hydrochloride PO QD on days 2-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Erlotinib Hydrochloride: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
|
|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
16.0%
4/25 • Number of events 4 • 3 years
|
34.0%
17/50 • Number of events 17 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
16.0%
4/25 • Number of events 4 • 3 years
|
40.0%
20/50 • Number of events 20 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
2/25 • Number of events 2 • 3 years
|
26.0%
13/50 • Number of events 13 • 3 years
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/25 • 3 years
|
12.0%
6/50 • Number of events 6 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
12.0%
3/25 • Number of events 3 • 3 years
|
46.0%
23/50 • Number of events 23 • 3 years
|
|
General disorders
Dehydration
|
12.0%
3/25 • Number of events 3 • 3 years
|
14.0%
7/50 • Number of events 7 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.0%
4/25 • Number of events 4 • 3 years
|
26.0%
13/50 • Number of events 13 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
28.0%
7/25 • Number of events 7 • 3 years
|
70.0%
35/50 • Number of events 35 • 3 years
|
|
Endocrine disorders
Transaminases
|
12.0%
3/25 • Number of events 3 • 3 years
|
18.0%
9/50 • Number of events 9 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
5/25 • Number of events 5 • 3 years
|
30.0%
15/50 • Number of events 15 • 3 years
|
|
General disorders
Infection
|
8.0%
2/25 • Number of events 2 • 3 years
|
2.0%
1/50 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
56.0%
14/25 • Number of events 14 • 3 years
|
66.0%
33/50 • Number of events 33 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place