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

Primary Purpose

Non-small Cell Lung Carcinoma

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

chemotherapy

About this trial

This is an interventional treatment trial for Non-small Cell Lung Carcinoma focused on measuring on-small cell lung carcinoma, chemotherapy naive patient

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)
Age > 18
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

Sites / Locations

Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm 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)

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

Outcomes

Primary Outcome Measures

overall Response Rate

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

Progression free survival

overall survival

duration of response

disease control rate

Full Information

NCT ID

NCT01648517

First Posted

July 1, 2012

Last Updated

November 26, 2017

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT01648517

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

July 27, 2012 (Actual)

Primary Completion Date

June 30, 2015 (Actual)

Study Completion Date

June 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Carcinoma

Keywords

on-small cell lung carcinoma, chemotherapy naive patient

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

Arm Title

Arm B

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

chemotherapy

Other Intervention Name(s)

Docetaxel - Taxotere, Vinorelbine: Sandoz vinorelbine, Carboplatin: Carplan, Gemcitabine: Gemzar

Intervention Description

A1: docetaxel 60mg/m2 on Day 1 vinorelbine 20mg/m2 on Day 1 and Day 8 (DV) A2: gemcitabine 1000mg/m2 on Day 1 vinorelbine 25mg/m2 on Day 1 and Day 8 (GV) A3: docetaxel 75mg/m2 on Day 1 carboplatin AUC5 on Day 1 (DC) A4: gemcitabine 1000mg/m2 on Day 1 and 8 carboplatin AUC5 on Day 1 (GC)

Intervention Type

Drug

Intervention Name(s)

chemotherapy

Other Intervention Name(s)

Docetaxel - Taxotere, Carboplatin: Carplan

Intervention Description

Drug: Docetaxel 75mg/m2 IV on Day 1 Drug: Carboplatin AUC5 IV on Day 1

Primary Outcome Measure Information:

Title

overall Response Rate

Description

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

Secondary Outcome Measure Information:

Title

Progression free survival

Time Frame

up to 4 years

Title

overall survival

Time Frame

up to 4 years

Title

duration of response

Time Frame

up to 4 years

Title

disease control rate

Time Frame

up to 4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.) Age > 18 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

Facility Information:

Facility Name

Severance Hospital

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

26811178

Citation

Heo SJ, Jung I, Lee CK, Kim JH, Lim SM, Moon YW, Shim HS, Jeong J, Kim JH, Kim HR, Cho BC. A randomized phase II trial of ERCC1 and RRM1 mRNA expression-based chemotherapy versus docetaxel/carboplatin in advanced non-small cell lung cancer. Cancer Chemother Pharmacol. 2016 Mar;77(3):539-48. doi: 10.1007/s00280-016-2968-z. Epub 2016 Jan 25.

Results Reference

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

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