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Report for Clinical Trial NCT03267654

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

This is an open-label, multicenter, randomized, phase II clinical trial, which aims to evaluate the effectiveness and safety of gefitinib versus combination of gefitinib and doublet chemotherapy or apatinib in advanced non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) activating mutation (exon 19 deletion or exon 21 L858R point mutation), accompanied with Bim deletion or low activating EGFR mutation abundance.

NCT03267654 Non-small-cell Lung Cancer
MeSH: Carcinoma, Non-Small-Cell Lung
HPO: Non-small cell lung carcinoma

3 Interventions

Name: gefitinib combined with chemotherapy

Description: 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.

Type: Drug

gefitinib combined with chemotherapy

Name: gefitinib combined with apatinib

Description: 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.

Type: Drug

gefitinib combined with apatinib

Name: gefitinib single agent

Description: Patients received Gefitinib 250mg q.d. orally until disease progression, intolerable toxicity or death.

Type: Drug

gefitinib single agent


Primary Outcomes

Description: From start of anti-cancer therapy until progression or death

Measure: Progression free survival

Time: 8 weeks

Secondary Outcomes

Description: evaluated in the 36th since treatment begain

Measure: overall survival

Time: 36 months

Description: Evaluated the rate of complete response and partial response in the 8 weeks since treatment began

Measure: objective response rate

Time: 8 weeks

Description: Evaluated the rate of complete response,partial response and stable disease in the 8 weeks since anti-cancer therapy

Measure: disease control rate

Time: 8 weeks

Description: interval between the time which complete response or partial response happened and progressive disease or death

Measure: duration of response

Time: 8 weeks

Description: 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.

Measure: safety evaluation

Time: 8 weeks

Description: 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.

Measure: compare quality of life

Time: 24 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

Gefitinib With Chemotherapy or Anti-angiogenesis in NSCLC Patients With Bim Deletion or Low EGFR Mutation Abundance This is an open-label, multicenter, randomized, phase II clinical trial, which aims to evaluate the effectiveness and safety of gefitinib versus combination of gefitinib and doublet chemotherapy or apatinib in advanced non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) activating mutation (exon 19 deletion or exon 21 L858R point mutation), accompanied with Bim deletion or low activating EGFR mutation abundance. --- L858R ---

3. EGFR mutation (exon 19 deletion or exon 21 L858R) with Bim deletion or low abundance for EGFR mutation. --- L858R ---



HPO Nodes


HPO:
Non-small cell lung carcinoma
Genes 3
TP53 TP53 BAP1