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

Yonsei University

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Carcinoma

Treatments: Drug: chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01648517

4-2008-0132

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Arm A

Experimental group

Description:

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)

Treatment:

Drug: chemotherapy

Drug: chemotherapy

Arm B

Active Comparator group

Description:

standard of care All control arm patients received standard platinum-based doublet chemotherapy with docetaxel plus carboplatin

Treatment:

Drug: chemotherapy

Drug: chemotherapy