Genotype-Driven Treatment of Advanced Non-small Cell Lung Cancer Based on mRNA Expression of ERCC1 & RRM1 as First-line Chemotherapy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Yonsei University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- overall Response Rate
Study Overview
Brief Summary
This is a prospective phase II trial, in patients with unresectable or metastatic NSCLC using chemotherapy regimens which will be defined according to the mRNA expression of ERCC1 and RRM1 of the tumor cells.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically confirmed unresectable advanced or metastatic non-small cell lung cancer (NSCLC) (stage IIIB or IV)
- •Chemotherapy naïve patient (Previous adjuvant or neoadjuvant chemotherapy allowed if the last dose was administered equal to or greater than 6 months ago.)
- •Performance status 0 to 2 by Eastern Cooperative Oncology Group (ECOG) criteria
- •At least one measurable lesion by Response Evaluation Criteria In Solid Tumors (RECIST)
- •Adequate organ functions (assessed within 14 days of starting treatment) 1) Bone marrow: Absolute neutrophil count ≥ 1,500/mm³, Platelet count ≥ 100,000/mm³, Hemoglobin ≥ 9.0 mg/dL 2) Liver: Total bilirubin ≤ 1.5 x ULN; aspartic transaminase (AST) and alanine transaminase (ALT), alkaline phosphatase(ALP) ≤ 2.5 x ULN 3) Kidney: Serum creatinine ≤ 1.5 x ULN
- •Signed informed consent document
Exclusion Criteria
- •Clinically significant serious illness or medical condition (infection)
- •Prior systemic chemotherapy or immunotherapy for advanced NSCLC.
- •Presence of uncontrolled brain or leptomeningeal metastases
- •Prior radiotherapy within 3 weeks of starting treatment
- •Peripheral neuropathy equal to or greater than grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
- •Pregnant or lactating
- •Absolute contraindication of corticosteroid use
- •Patients with a history of severe hypersensitivity reaction to docetaxel, carboplatin, vinorelbine or gemcitabine
Arms & Interventions
Arm A
Genomic-driven dual agent chemotherapy Chemotherapy will consist of the assigned two drugs according to ERCC1 and RRM1 mRNA expression level A1: docetaxel + vinorelbine (DV) A2: gemcitabine + vinorelbine (GV) A3: docetaxel + carboplatin (DC) A4: gemcitabine + carboplatin (GC)
Intervention: chemotherapy (Drug)
Arm B
standard of care All control arm patients received standard platinum-based doublet chemotherapy with docetaxel plus carboplatin
Intervention: chemotherapy (Drug)
Outcomes
Primary Outcomes
overall Response Rate
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
ORR was assessed by tumor response evaluation according to RECIST 1.1 at every 8 weeks. Tumor assessments will continue about every 8 weeks until disease progression or initiation of subsequent anticancer treatment. (If PR or CR was first documented, confirmation assessment was done between 4 weeks and 8 weeks)
Secondary Outcomes
- disease control rate(up to 4 years)
- Progression free survival(up to 4 years)
- duration of response(up to 4 years)
- overall survival(up to 4 years)