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Report for Clinical Trial NCT03117049
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
The purpose of study is to compare the efficacy and safety of ONO-4538 in combination with
carboplatin, paclitaxel, and bevacizumab (ONO-4538 group) to placebo in combination with
carboplatin, paclitaxel, and bevacizumab (placebo group) in chemotherapy-naïve subjects with
stage IIIB/IV or recurrent non-squamous non-small cell lung cancer unsuitable for radical
radiation in a multicenter, randomized, double-blind study.
Name: ONO-4538
Description: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Type: Drug
Group Labels: 1 ONO-4538 group
Name: Carboplatin
Description: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Type: Drug
Group Labels: 2 ONO-4538 group Placebo group
Name: Paclitaxel
Description: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Type: Drug
Group Labels: 2 ONO-4538 group Placebo group
Name: Bevacizumab
Description: Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Type: Drug
Group Labels: 2 ONO-4538 group Placebo group
Name: Placebo
Description: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Type: Drug
Group Labels: 1 Placebo group
Primary Outcomes
Measure: Progression Free Survival (PFS) as assessed by the Independent Radiology Review Committee (IRRC) Time: Up to approximately 3 years
Secondary Outcomes
Measure: Overall survival (OS) Time: At least 3 years
Measure: PFS (as assessed by the study site's investigator) Time: Up to approximately 3 years
Measure: Objective response rate (ORR [as assessed by the IRRC and study site's investigator]) Time: Up to approximately 3 years
Measure: Disease control rate (DCR [as assessed by the IRRC and study site's investigator]) Time: Up to approximately 3 years
Measure: Duration of response (DOR [as assessed by the IRRC]) Time: Up to approximately 3 years
Measure: Time to response (TTR [as assessed by the IRRC]) Time: Up to approximately 3 years
Measure: Best overall response (BOR [as assessed by the IRRC and study site's investigator]) Time: Up to approximately 3 years
Measure: Maximum percentage of change in the sum of diameters of target lesions (as assessed by the IRRC) Time: Up to approximately 3 years
Measure: Safety will be analyzed through the incidence of adverse events, serious adverse events Time: Up to 100 days from last dose
Measure: Patient reported outcome (PRO) Time: Up to approximately 5 years
Purpose: Treatment
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
1 L858R
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1
Exclusion Criteria:
- Subjects with known EGFR mutations, including deletions in exon 19 and exon 21 (L858R)
substitution mutations. --- L858R ---