Gefitinib With Chemotherapy or Anti-angiogenesis in NSCLC Patients With Bim Deletion or Low EGFR Mutation Abundance
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|ClinicalTrials.gov Identifier: NCT03267654|
Recruitment Status : Unknown
Verified August 2017 by Qilu Pharmaceutical Co., Ltd..
Recruitment status was: Recruiting
First Posted : August 30, 2017
Last Update Posted : August 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non-small-cell Lung Cancer||Drug: gefitinib combined with chemotherapy Drug: gefitinib combined with apatinib Drug: gefitinib single agent||Phase 2|
BIM (bcl-2 interacting mediator of cell death) deletion polymorphism and low EGFR mutation abundance were poor clinical response markers to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) in NSCLC patients who had EGFR mutations.This is a phase II clinical trial to investigate the efficacy of combination treatment for patients harboring above risk factors.
Advanced EGFR mutated NSCLC Patients with Bim deletion or EGFR low mutation abundance were randomized divided into following three treatment groups:
A: gefitinib 250mg Qd combined with doublet chemotherapy: pemetrexed (500mg/m²，day 1 ，intravenously) plus carboplatin (AUC=5,day 1,intravenously) every 21 days.
B: gefitinib 250mg Qd combined with apatinib 250mg/d intravenously per 21 days. C: gefitinib 250mg Qd
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Gefitinib Versus Combination of Gefitinib With Chemotherapy or Anti-angiogenesis as 1st Line Treatment in Advanced NSCLC Patients Detected With Bim Deletion or Low EGFR Activating Mutation Abundance：A Randomized, Multicentre, Phase II Study|
|Actual Study Start Date :||October 12, 2017|
|Estimated Primary Completion Date :||August 20, 2019|
|Estimated Study Completion Date :||August 20, 2019|
Experimental: gefitinib combined with chemotherapy
gefitinib 250mg Qd combined with pemetrexed plus carboplatin: pemetrexed (500mg/m²day 1 intravenously) plus carboplatin (AUC=5,day 1,intravenously) every 21 days.
Drug: gefitinib combined with chemotherapy
Gefitinib 250mg, p.o., q.d., continuous regimens on an empty stomach or after meal for 2 hours until disease progression, intolerable toxicity or patient withdraw ICF.
Pemetrexed (500mg/m²day 1 intravenously) plus carboplatin (AUC=5,day 1,intravenously) every 21 days. Every 3 weeks is a chemotherapy cycle, and 4 chemotherapy cycles is maximum limit.
Other Name: yiruike
Experimental: gefitinib combined with apatinib
gefitinib 250mg Qd combined with apatinib 250mg per 21 days
Drug: gefitinib combined with apatinib
gefitinib 250mg, p.o., q.d., continuous regimens on an empty stomach or after meal for 2 hours.
Apatinib 250mg, p.o., q.d. per 21 days. until disease progression, intolerable toxicity, patient withdraw ICF or death.
Other Name: yiruike
Active Comparator: gefitinib single agent
Advanced NSCLC patients with EGFR activating mutation (L858R, 19Del) received gefitinib 250mg Qd orally until progression, intolerable toxicity or death.
Drug: gefitinib single agent
Patients received Gefitinib 250mg q.d. orally until disease progression, intolerable toxicity or death.
Other Name: yiruike
- Progression free survival [ Time Frame: 8 weeks ]From start of anti-cancer therapy until progression or death
- overall survival [ Time Frame: 36 months ]evaluated in the 36th since treatment begain
- objective response rate [ Time Frame: 8 weeks ]Evaluated the rate of complete response and partial response in the 8 weeks since treatment began
- disease control rate [ Time Frame: 8 weeks ]Evaluated the rate of complete response，partial response and stable disease in the 8 weeks since anti-cancer therapy
- duration of response [ Time Frame: 8 weeks ]interval between the time which complete response or partial response happened and progressive disease or death
- safety evaluation [ Time Frame: 8 weeks ]Safety observation indexes were listed as following: adverse events and serious adverse events (according to CommonTerminology Criteria Adverse Events Version 4.03), physical exam, vital signs(blood pressure, heart rate, respiratory rate,body temperature), weight variation, laboratory examination(hematology, blood biochemistry, urinalysis and so on), electrocardiograph(ECG),ultrasonic cardiogram(UCG), ect.
- compare quality of life [ Time Frame: 24 months ]Quality of Life Questionnaire(including QLQ-C30 and QLQ-LC13) evaluated since treatment began.At the end of the trial, the differences between the two indicators were compared with Mixed-effects model repeated measures (MMRM), where the baseline was scored as a covariant and the treatment group as a fixed variable. In addition, the baseline values of the two scores, the value of each visit, and the change value of the baseline were statistically described.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03267654
|Contact: Caicun Zhou, MDfirstname.lastname@example.org|
|Shanghai Pulmonary Hospital;||Recruiting|
|Shanghai, Shanghai, China, 200000|
|Contact: Caicun Zhou, MD|
|Principal Investigator:||Caicun Zhou||Shanghai Pulmonary Hospital, Shanghai, China|