Trial Outcomes & Findings for Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced NSCLC Metastatic Non-small Cell Lung Cancer (NCT NCT01194453)

NCT ID: NCT01194453

Last Updated: 2016-06-16

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 288 participants
• Primary outcome timeframe: 36months
• Results posted on: 2016-06-16

Participant Flow

Participant milestones

Measure	Group A cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment	Group B cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
Overall Study STARTED	144	144
Overall Study COMPLETED	127	127
Overall Study NOT COMPLETED	17	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced NSCLC Metastatic Non-small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Group A n=144 Participants cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment	Group B n=144 Participants cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8	Total n=288 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	129 Participants n=93 Participants	120 Participants n=4 Participants	249 Participants n=27 Participants
Age, Categorical >=65 years	15 Participants n=93 Participants	24 Participants n=4 Participants	39 Participants n=27 Participants
Sex: Female, Male Female	60 Participants n=93 Participants	73 Participants n=4 Participants	133 Participants n=27 Participants
Sex: Female, Male Male	84 Participants n=93 Participants	71 Participants n=4 Participants	155 Participants n=27 Participants
Region of Enrollment China	144 participants n=93 Participants	144 participants n=4 Participants	288 participants n=27 Participants

PRIMARY outcome

Timeframe: 36months

Outcome measures

Measure	Group A n=144 Participants cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment	Group B n=144 Participants cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
Progression Free Survival (PFS)	168 day Interval 139.0 to 183.0	140 day Interval 113.0 to 164.0

SECONDARY outcome

Timeframe: 6 weeks

Outcome measures

Measure	Group A n=127 Participants cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment	Group B n=127 Participants cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
Response Rate	24.41 percentage	14.17 percentage

Adverse Events

Group A

Serious events: 5 serious events

Other events: 131 other events

Deaths: 0 deaths

Group B

Serious events: 5 serious events

Other events: 140 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group A n=144 participants at risk cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment	Group B n=144 participants at risk cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
Respiratory, thoracic and mediastinal disorders Leading to Hospitalization	2.1% 3/144 • Number of events 3 • From the delivery of the study drug to 21 days post the last dose of study drug.	1.4% 2/144 • Number of events 2 • From the delivery of the study drug to 21 days post the last dose of study drug.
General disorders Death	0.69% 1/144 • Number of events 1 • From the delivery of the study drug to 21 days post the last dose of study drug.	0.69% 1/144 • Number of events 1 • From the delivery of the study drug to 21 days post the last dose of study drug.
General disorders Life threatening	0.69% 1/144 • Number of events 1 • From the delivery of the study drug to 21 days post the last dose of study drug.	0.69% 1/144 • Number of events 1 • From the delivery of the study drug to 21 days post the last dose of study drug.
Cardiac disorders Delay hospitalization	0.00% 0/144 • From the delivery of the study drug to 21 days post the last dose of study drug.	0.69% 1/144 • Number of events 1 • From the delivery of the study drug to 21 days post the last dose of study drug.

Other adverse events

Measure	Group A n=144 participants at risk cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment	Group B n=144 participants at risk cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
Blood and lymphatic system disorders leukopenia	43.8% 63/144 • Number of events 63 • From the delivery of the study drug to 21 days post the last dose of study drug.	47.9% 69/144 • Number of events 69 • From the delivery of the study drug to 21 days post the last dose of study drug.
Blood and lymphatic system disorders neutropenia	44.4% 64/144 • Number of events 64 • From the delivery of the study drug to 21 days post the last dose of study drug.	41.0% 59/144 • Number of events 59 • From the delivery of the study drug to 21 days post the last dose of study drug.
Blood and lymphatic system disorders anemia	23.6% 34/144 • Number of events 34 • From the delivery of the study drug to 21 days post the last dose of study drug.	33.3% 48/144 • Number of events 48 • From the delivery of the study drug to 21 days post the last dose of study drug.

Additional Information

Dr. Li Zhang

Sun Yat-sen University Cancer Center

Phone: 87342288

Email: zhangli6@mail.sysu.edu.cn

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place