Trial Outcomes & Findings for Study of Pemetrexed Plus Cisplatin as First-line Therapy in Patients With Advanced Non-squamous NSCLC (NCT NCT01088906)
NCT ID: NCT01088906
Last Updated: 2024-10-15
Results Overview
The percentage of patients who have experienced a tumor response since the start of treatment. Per 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
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
From start of treatment to end of follow up, up to 24 months
Results posted on
2024-10-15
Participant Flow
Dates of recruitment: start date: 20 January 2010 and ended at 19 February 2014.
Participant milestones
| Measure |
Experimental: Pemetrexed Plus Cisplatin
Pemetrexed 500 mg/m2 IV + cisplatin 75 mg/m2 every 21 days
Pemetrexed/Cisplatin: Pemetrexed 500 mg/m2 IV followed by cisplatin 75 mg/m2 IV every 21 days. A cycle is 21 day. Total: 6 cycles.
|
|---|---|
|
Overall Study
STARTED
|
57
|
|
Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Experimental: Pemetrexed Plus Cisplatin
Pemetrexed 500 mg/m2 IV + cisplatin 75 mg/m2 every 21 days
Pemetrexed/Cisplatin: Pemetrexed 500 mg/m2 IV followed by cisplatin 75 mg/m2 IV every 21 days. A cycle is 21 day. Total: 6 cycles.
|
|---|---|
|
Overall Study
Inclusion error
|
1
|
|
Overall Study
Did not receive study treatment
|
3
|
|
Overall Study
Missing data
|
1
|
Baseline Characteristics
Study of Pemetrexed Plus Cisplatin as First-line Therapy in Patients With Advanced Non-squamous NSCLC
Baseline characteristics by cohort
| Measure |
EXPERIMENTAL ARM
n=52 Participants
Pemetrexed 500 mg/m2 IV + cisplatin 75 mg/m2 every 21 days
Pemetrexed/Cisplatin: Pemetrexed 500 mg/m2 IV followed by cisplatin 75 mg/m2 IV every 21 days. A cycle is 21 day. Total: 6 cycles.
|
|---|---|
|
Smoking status
Never
|
5 participants
n=5 Participants
|
|
Smoking status
Former
|
31 participants
n=5 Participants
|
|
Smoking status
Smoker
|
16 participants
n=5 Participants
|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
52 participants
n=5 Participants
|
|
ECOG
ECOG 0
|
14 participants
n=5 Participants
|
|
ECOG
ECOG 1
|
33 participants
n=5 Participants
|
|
ECOG
ECOG UK
|
5 participants
n=5 Participants
|
|
Histology
Adenocarcinoma
|
51 participants
n=5 Participants
|
|
Histology
Large Cell Lung Carcinoma
|
1 participants
n=5 Participants
|
|
Treatment compliance
Cycle 1 completed
|
1 participants
n=5 Participants
|
|
Treatment compliance
Cycle 2 completed
|
7 participants
n=5 Participants
|
|
Treatment compliance
Cycle 3 completed
|
6 participants
n=5 Participants
|
|
Treatment compliance
Cycle 4 completed
|
8 participants
n=5 Participants
|
|
Treatment compliance
Cycle 5 completed
|
4 participants
n=5 Participants
|
|
Treatment compliance
Cycle 6 completed
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment to end of follow up, up to 24 monthsPopulation: The percentage of patients who have experienced tumor regression since the start of treatment (Complete response + Partial response) among the total of patients ORR = 26%
The percentage of patients who have experienced a tumor response since the start of treatment. Per 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
Outcome measures
| Measure |
EXPERIMENTAL ARM
n=52 Participants
Pemetrexed 500 mg/m2 IV + cisplatin 75 mg/m2 every 21 days
Pemetrexed/Cisplatin: Pemetrexed 500 mg/m2 IV followed by cisplatin 75 mg/m2 IV every 21 days. A cycle is 21 day. Total: 6 cycles.
|
|---|---|
|
Objective Response Rate
Stable disease
|
44 percentage of participants
|
|
Objective Response Rate
Partial response
|
22 percentage of participants
|
|
Objective Response Rate
Complete response
|
4 percentage of participants
|
|
Objective Response Rate
Progression
|
30 percentage of participants
|
SECONDARY outcome
Timeframe: From the date of enrollment until end of follow up, up to 24 months.Overall survival is measured from the date of enrollment to the date of death from any cause
Outcome measures
| Measure |
EXPERIMENTAL ARM
n=52 Participants
Pemetrexed 500 mg/m2 IV + cisplatin 75 mg/m2 every 21 days
Pemetrexed/Cisplatin: Pemetrexed 500 mg/m2 IV followed by cisplatin 75 mg/m2 IV every 21 days. A cycle is 21 day. Total: 6 cycles.
|
|---|---|
|
Overall Survival
|
11.267 Month
Interval 9.141 to 13.392
|
SECONDARY outcome
Timeframe: From the date of enrollment until end of follow up, up to 24 months.This interval is measured in months from the date of entry into the study until the first date of the appearance of new metastatic lesions or objective progression of the disease. 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 |
EXPERIMENTAL ARM
n=52 Participants
Pemetrexed 500 mg/m2 IV + cisplatin 75 mg/m2 every 21 days
Pemetrexed/Cisplatin: Pemetrexed 500 mg/m2 IV followed by cisplatin 75 mg/m2 IV every 21 days. A cycle is 21 day. Total: 6 cycles.
|
|---|---|
|
Time to Progression
|
5.633 Month
Interval 4.18 to 7.087
|
SECONDARY outcome
Timeframe: From the date of enrollment until end of follow up, up to 24 months.Population: The number of subjects analyzed depends on BRCA results
This interval is measured from the date of entry into the study until the first date of the appearance of new metastatic lesions or objective progression of the disease for patients with biomarker BRCA1.
Outcome measures
| Measure |
EXPERIMENTAL ARM
n=52 Participants
Pemetrexed 500 mg/m2 IV + cisplatin 75 mg/m2 every 21 days
Pemetrexed/Cisplatin: Pemetrexed 500 mg/m2 IV followed by cisplatin 75 mg/m2 IV every 21 days. A cycle is 21 day. Total: 6 cycles.
|
|---|---|
|
Time to Progression of Patients According the Results of Biomarker BRCA1
BRCA1 negative
|
5.270 Month
Interval 3.443 to 7.097
|
|
Time to Progression of Patients According the Results of Biomarker BRCA1
BRCA1 positive
|
3.430 Month
Interval 0.564 to 6.296
|
|
Time to Progression of Patients According the Results of Biomarker BRCA1
All patients (BRCA1 positive+negative)
|
5.270 Month
Interval 2.678 to 7.862
|
SECONDARY outcome
Timeframe: From the date of enrollment until end of follow up, up to 24 months.Population: The subjects analyzed depends on RAP80 results.
This interval is measured from the date of entry into the study until the first date of the appearance of new metastatic lesions or objective progression of the disease.
Outcome measures
| Measure |
EXPERIMENTAL ARM
n=52 Participants
Pemetrexed 500 mg/m2 IV + cisplatin 75 mg/m2 every 21 days
Pemetrexed/Cisplatin: Pemetrexed 500 mg/m2 IV followed by cisplatin 75 mg/m2 IV every 21 days. A cycle is 21 day. Total: 6 cycles.
|
|---|---|
|
Time to Progression of Patients According the Results of Biomarker RAP80
RAP80 negative
|
5.630 Month
Interval 2.416 to 8.844
|
|
Time to Progression of Patients According the Results of Biomarker RAP80
RAP80 positive
|
3.430 Month
Interval 0.0 to 7.354
|
|
Time to Progression of Patients According the Results of Biomarker RAP80
All patients (RAP80 positive+negative)
|
5.370 Month
Interval 2.43 to 8.31
|
SECONDARY outcome
Timeframe: From the date of enrollment until end of follow up, up to 24 months.Population: The subjects analyzed depends on TS results.
This interval is measured from the date of entry into the study until the first date of the appearance of new metastatic lesions or objective progression of the disease.
Outcome measures
| Measure |
EXPERIMENTAL ARM
n=52 Participants
Pemetrexed 500 mg/m2 IV + cisplatin 75 mg/m2 every 21 days
Pemetrexed/Cisplatin: Pemetrexed 500 mg/m2 IV followed by cisplatin 75 mg/m2 IV every 21 days. A cycle is 21 day. Total: 6 cycles.
|
|---|---|
|
Time to Progression of Patients According the Results of Biomarker TS
TS negative
|
5.630 Month
Interval 0.249 to 11.011
|
|
Time to Progression of Patients According the Results of Biomarker TS
TS positive
|
3.330 Month
Interval 2.59 to 4.07
|
|
Time to Progression of Patients According the Results of Biomarker TS
All patients (TS positive+negative)
|
3.430 Month
Interval 1.738 to 5.122
|
SECONDARY outcome
Timeframe: From the date of enrollment until end of follow up, up to 24 months.Population: The subjects analyzed depends on BRCA1 results.
Overall survival is measured from the date of enrollment to the date of death from any cause
Outcome measures
| Measure |
EXPERIMENTAL ARM
n=52 Participants
Pemetrexed 500 mg/m2 IV + cisplatin 75 mg/m2 every 21 days
Pemetrexed/Cisplatin: Pemetrexed 500 mg/m2 IV followed by cisplatin 75 mg/m2 IV every 21 days. A cycle is 21 day. Total: 6 cycles.
|
|---|---|
|
Overall Survival of Patients According the Results of Biomarker BRCA1
All patients (BRCA1 positive+negative)
|
10.570 Month
Interval 6.921 to 14.219
|
|
Overall Survival of Patients According the Results of Biomarker BRCA1
BRCA1 negative
|
12.270 Month
Interval 7.605 to 16.935
|
|
Overall Survival of Patients According the Results of Biomarker BRCA1
BRCA1 positive
|
8.400 Month
Interval 0.864 to 15.936
|
SECONDARY outcome
Timeframe: From the date of enrollment until end of follow up, up to 24 months.Population: The subjects analyzed depends on RAP80 results.
Overall survival is measured from the date of enrollment to the date of death from any cause
Outcome measures
| Measure |
EXPERIMENTAL ARM
n=52 Participants
Pemetrexed 500 mg/m2 IV + cisplatin 75 mg/m2 every 21 days
Pemetrexed/Cisplatin: Pemetrexed 500 mg/m2 IV followed by cisplatin 75 mg/m2 IV every 21 days. A cycle is 21 day. Total: 6 cycles.
|
|---|---|
|
Overall Survival of Patients According the Results of Biomarker RAP80
RAP80 negative
|
10.570 Month
Interval 0.0 to 24.843
|
|
Overall Survival of Patients According the Results of Biomarker RAP80
RAP80 positive
|
9.600 Month
Interval 4.787 to 14.413
|
|
Overall Survival of Patients According the Results of Biomarker RAP80
All patients (RAP80 positive+negative)
|
10.570 Month
Interval 5.865 to 15.275
|
SECONDARY outcome
Timeframe: From the date of enrollment until end of follow up, up to 24 months.Population: The subjects analyzed depends on TS results.
Overall survival is measured from the date of enrollment to the date of death from any cause.
Outcome measures
| Measure |
EXPERIMENTAL ARM
n=52 Participants
Pemetrexed 500 mg/m2 IV + cisplatin 75 mg/m2 every 21 days
Pemetrexed/Cisplatin: Pemetrexed 500 mg/m2 IV followed by cisplatin 75 mg/m2 IV every 21 days. A cycle is 21 day. Total: 6 cycles.
|
|---|---|
|
Overall Survival of Patients According the Results of Biomarker TS
TS negative
|
12.270 Month
Interval 2.136 to 22.404
|
|
Overall Survival of Patients According the Results of Biomarker TS
TS positive
|
8.400 Month
Interval 0.473 to 16.327
|
|
Overall Survival of Patients According the Results of Biomarker TS
All patients (TS positive+negative)
|
11.270 Month
Interval 5.351 to 17.189
|
Adverse Events
Experimental Arm: Pemetrexed Plus Cisplatin
Serious events: 25 serious events
Other events: 40 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Experimental Arm: Pemetrexed Plus Cisplatin
n=52 participants at risk
Pemetrexed 500 mg/m2 IV + cisplatin 75 mg/m2 every 21 days
Pemetrexed/Cisplatin: Pemetrexed 500 mg/m2 IV followed by cisplatin 75 mg/m2 IV every 21 days. A cycle is 21 day. Total: 6 cycles.
|
|---|---|
|
Vascular disorders
Lower member embolism
|
1.9%
1/52 • Number of events 1 • 25 months
|
|
Vascular disorders
Stroke ischemic and pneumonia
|
1.9%
1/52 • Number of events 1 • 25 months
|
|
Vascular disorders
Acute ischemia of lower limbs
|
1.9%
1/52 • Number of events 1 • 25 months
|
|
Vascular disorders
Pulmonary thromboembolism
|
7.7%
4/52 • Number of events 4 • 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
1/52 • Number of events 1 • 25 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
3.8%
2/52 • Number of events 2 • 25 months
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
1.9%
1/52 • Number of events 1 • 25 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
9.6%
5/52 • Number of events 5 • 25 months
|
|
Nervous system disorders
Disorientation and loss motor control
|
1.9%
1/52 • Number of events 1 • 25 months
|
|
General disorders
Fatigue
|
1.9%
1/52 • Number of events 1 • 25 months
|
|
General disorders
Hyporexia
|
1.9%
1/52 • Number of events 1 • 25 months
|
|
Gastrointestinal disorders
Nausea and vomiting
|
1.9%
1/52 • Number of events 1 • 25 months
|
|
General disorders
Pain
|
1.9%
1/52 • Number of events 1 • 25 months
|
|
General disorders
Anorexy
|
1.9%
1/52 • Number of events 1 • 25 months
|
|
Gastrointestinal disorders
Mucositis
|
1.9%
1/52 • Number of events 1 • 25 months
|
|
Gastrointestinal disorders
Intestinal perforation
|
1.9%
1/52 • Number of events 1 • 25 months
|
|
Gastrointestinal disorders
Diarrhea
|
1.9%
1/52 • Number of events 1 • 25 months
|
|
General disorders
Fever
|
1.9%
1/52 • Number of events 1 • 25 months
|
|
Gastrointestinal disorders
Rectal bleeding
|
1.9%
1/52 • Number of events 1 • 25 months
|
|
Renal and urinary disorders
Impaired function renal
|
3.8%
2/52 • Number of events 2 • 25 months
|
|
Renal and urinary disorders
Urinary infection
|
1.9%
1/52 • Number of events 1 • 25 months
|
|
Musculoskeletal and connective tissue disorders
General stiffness
|
1.9%
1/52 • Number of events 1 • 25 months
|
|
Endocrine disorders
Oliguria
|
1.9%
1/52 • Number of events 1 • 25 months
|
|
Infections and infestations
Sepsis
|
1.9%
1/52 • Number of events 1 • 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral bronchopneumonia
|
1.9%
1/52 • Number of events 1 • 25 months
|
Other adverse events
| Measure |
Experimental Arm: Pemetrexed Plus Cisplatin
n=52 participants at risk
Pemetrexed 500 mg/m2 IV + cisplatin 75 mg/m2 every 21 days
Pemetrexed/Cisplatin: Pemetrexed 500 mg/m2 IV followed by cisplatin 75 mg/m2 IV every 21 days. A cycle is 21 day. Total: 6 cycles.
|
|---|---|
|
Immune system disorders
Hypersensitivity
|
1.9%
1/52 • Number of events 1 • 25 months
|
|
Blood and lymphatic system disorders
Haemoglobin
|
76.9%
40/52 • Number of events 40 • 25 months
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
38.5%
20/52 • Number of events 20 • 25 months
|
|
Blood and lymphatic system disorders
Neutrophils
|
26.9%
14/52 • Number of events 14 • 25 months
|
|
Blood and lymphatic system disorders
Platelets
|
11.5%
6/52 • Number of events 6 • 25 months
|
|
General disorders
Edema
|
5.8%
3/52 • Number of events 3 • 25 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.8%
2/52 • Number of events 2 • 25 months
|
|
Nervous system disorders
Neurotoxicity sensitive
|
15.4%
8/52 • Number of events 8 • 25 months
|
|
Eye disorders
Conjunctivitis
|
5.8%
3/52 • Number of events 3 • 25 months
|
|
General disorders
Fatigue
|
67.3%
35/52 • Number of events 35 • 25 months
|
|
General disorders
Fever
|
1.9%
1/52 • Number of events 1 • 25 months
|
|
Ear and labyrinth disorders
Ototoxicity
|
5.8%
3/52 • Number of events 3 • 25 months
|
|
Gastrointestinal disorders
Diarrhea
|
13.5%
7/52 • Number of events 7 • 25 months
|
|
Gastrointestinal disorders
Dysgeusia
|
7.7%
4/52 • Number of events 4 • 25 months
|
|
Gastrointestinal disorders
Constipation
|
25.0%
13/52 • Number of events 13 • 25 months
|
|
Gastrointestinal disorders
Mucositis
|
23.1%
12/52 • Number of events 12 • 25 months
|
|
Gastrointestinal disorders
Nausea-vomiting
|
76.9%
40/52 • Number of events 40 • 25 months
|
|
Renal and urinary disorders
Impaired function renal
|
5.8%
3/52 • Number of events 3 • 25 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.6%
5/52 • Number of events 5 • 25 months
|
|
Endocrine disorders
Increase AST/ALT
|
13.5%
7/52 • Number of events 7 • 25 months
|
|
Metabolism and nutrition disorders
Hyporexia
|
13.5%
7/52 • Number of events 7 • 25 months
|
|
Metabolism and nutrition disorders
Increase GGT
|
15.4%
8/52 • Number of events 8 • 25 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
15.4%
8/52 • Number of events 8 • 25 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.7%
4/52 • Number of events 4 • 25 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.7%
4/52 • Number of events 4 • 25 months
|
|
Metabolism and nutrition disorders
LDH increase
|
9.6%
5/52 • Number of events 5 • 25 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place