Genotype-Driven Treatment of Advanced Non-small Cell Lung Cancer Based on mRNA Expression of ERCC1 & RRM1 as First-line Chemotherapy

Phase 2

Completed

• Conditions: Non-small Cell Lung Carcinoma
• Interventions: Drug: chemotherapy

• Registration Number: NCT01648517
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-01
• Study First Submitted QC: 2012-07-19
• Study First Posted: 2012-07-24
• Study Start: 2012-07-27
• Primary Completion: 2015-06-30
• Study Completion: 2015-06-30
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-26
• Last Update Posted: 2017-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Histologically confirmed unresectable advanced or metastatic non-small cell lung cancer (NSCLC) (stage IIIB or IV)
2. Chemotherapy naïve patient (Previous adjuvant or neoadjuvant chemotherapy allowed if the last dose was administered equal to or greater than 6 months ago.)
3. Age > 18
4. Performance status 0 to 2 by Eastern Cooperative Oncology Group (ECOG) criteria
5. At least one measurable lesion by Response Evaluation Criteria In Solid Tumors (RECIST)
6. 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
7. Signed informed consent document

Exclusion Criteria

1. Clinically significant serious illness or medical condition (infection)
2. Prior systemic chemotherapy or immunotherapy for advanced NSCLC.
3. Presence of uncontrolled brain or leptomeningeal metastases
4. Prior radiotherapy within 3 weeks of starting treatment
5. Peripheral neuropathy equal to or greater than grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
6. Pregnant or lactating
7. Absolute contraindication of corticosteroid use
8. Patients with a history of severe hypersensitivity reaction to docetaxel, carboplatin, vinorelbine or gemcitabine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B	chemotherapy	standard of care All control arm patients received standard platinum-based doublet chemotherapy with docetaxel plus carboplatin
Arm A	chemotherapy	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)

Primary Outcome Measures

Name	Time	Method
overall Response Rate	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of