Trial Outcomes & Findings for Intercalating and Maintenance Use of Iressa Versus Chemotherapy in Selected Advanced Non Small Cell Lung Cancer (NCT NCT01404260)

Last Updated: 2017-01-27

Results Overview

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or progression in existing non-target lesions,or the appearance of one or more new lesions .

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

219 participants

Primary outcome timeframe

The evaluation of disease is demanded every two months for the patients receiving maintenance use of Gefitinib or patients in observation after chemotherapy,until disease progression occured

Results posted on

2017-01-27

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A: Gefitinib + Gemcitabine + Carboplatin Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, Gefitinib 250mg/d every cycle d15-25, and Gefitinib 250mg/d from d15 of last cycle until disease progression	Arm B: Gemcitabine + Carboplatin Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression
Overall Study STARTED	109	110
Overall Study COMPLETED	106	101
Overall Study NOT COMPLETED	3	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intercalating and Maintenance Use of Iressa Versus Chemotherapy in Selected Advanced Non Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A n=109 Participants Arm A: gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, gefitinib 250mg/d every cycle d15-25, and gefitinib 250mg/d from d15 of last cycle until disease progression gefitinib: gefitinib 250mg/d every cycle d15-25,and gefitinib 250mg/d from d15 of last cycle until disease progression	Arm B n=110 Participants gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression	Total n=219 Participants Total of all reporting groups
Age, Continuous	56 Years n=5 Participants	58 Years n=7 Participants	57 Years n=5 Participants
Gender Female	88 Participants n=5 Participants	83 Participants n=7 Participants	171 Participants n=5 Participants
Gender Male	21 Participants n=5 Participants	27 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	109 Participants n=5 Participants	110 Participants n=7 Participants	219 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment China	109 participants n=5 Participants	110 participants n=7 Participants	219 participants n=5 Participants

PRIMARY outcome

Timeframe: The evaluation of disease is demanded every two months for the patients receiving maintenance use of Gefitinib or patients in observation after chemotherapy,until disease progression occured

Population: Efficacy analysis, including PFS will be based on intent to treat (ITT) population.. ITT population includes all the randomised patients who receive at least one dose of study treatment with at least one baseline data of volume of plaque and at least one data after treatment.

Outcome measures

Outcome measures
Measure	Arm A: Gefitinib+Gemcitabine +Carboplatin n=106 Participants Arm A: Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, Gefitinib 250mg/d every cycle d15-25, and Gefitinib 250mg/d from d15 of last cycle until disease progression	Arm B: Gemcitabine +Carboplatin n=101 Participants Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression
Progression Free Survival	9.7 months Interval 5.9 to 11.3	4.2 months Interval 3.6 to 4.7

Adverse Events

Arm A

Serious events: 14 serious events

Other events: 9 other events

Deaths: 0 deaths

Arm B

Serious events: 5 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A n=109 participants at risk Arm A: gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, gefitinib 250mg/d every cycle d15-25, and gefitinib 250mg/d from d15 of last cycle until disease progression gefitinib: gefitinib 250mg/d every cycle d15-25,and gefitinib 250mg/d from d15 of last cycle until disease progression	Arm B n=110 participants at risk gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression
Blood and lymphatic system disorders Leukopenia	12.8% 14/109 • Number of events 17 • 4years Safety analysis included all patients who received at least one dose of the study drug and had at least one follow-up safety assessment. Safety assessments were analyzed mainly using descriptive statistics.	4.5% 5/110 • Number of events 26 • 4years Safety analysis included all patients who received at least one dose of the study drug and had at least one follow-up safety assessment. Safety assessments were analyzed mainly using descriptive statistics.

Other adverse events

Other adverse events
Measure	Arm A n=109 participants at risk Arm A: gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, gefitinib 250mg/d every cycle d15-25, and gefitinib 250mg/d from d15 of last cycle until disease progression gefitinib: gefitinib 250mg/d every cycle d15-25,and gefitinib 250mg/d from d15 of last cycle until disease progression	Arm B n=110 participants at risk gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression
Gastrointestinal disorders Diarrhea	8.3% 9/109 • Number of events 9 • 4years Safety analysis included all patients who received at least one dose of the study drug and had at least one follow-up safety assessment. Safety assessments were analyzed mainly using descriptive statistics.	0.91% 1/110 • Number of events 1 • 4years Safety analysis included all patients who received at least one dose of the study drug and had at least one follow-up safety assessment. Safety assessments were analyzed mainly using descriptive statistics.

Additional Information

Shun LU

Shanghai Chest Hospital

Phone: 86-2162821990

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60