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CompletedNCT01648517Updated Nov 28, 2017

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

A Phase 2 interventional study of chemotherapy and chemotherapy in Non-small Cell Lung Carcinoma, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-28.

Sponsored by Yonsei University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Non-small Cell Lung Carcinoma

Keywords

  • on-small cell lung carcinoma
  • chemotherapy naive patient
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    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)

    Drug: chemotherapy

  • Active comparator
    Arm B

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

    Drug: chemotherapy

Interventions

  • Drugchemotherapy

    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)

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

  • Drugchemotherapy

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

    Also known as: Docetaxel - Taxotere, Carboplatin: Carplan

06

What researchers measure

Primary outcomes

  1. 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)

    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 outcomes

  1. Progression free survival

    Time frame: up to 4 years

  2. overall survival

    Time frame: up to 4 years

  3. duration of response

    Time frame: up to 4 years

  4. disease control rate

    Time frame: up to 4 years

07

Study locations

1 site
  • Severance Hospital
    Seoul, 120-752, Korea, Republic of
08

References and documents

Publications

  • 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. PubMed 26811178 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01648517
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Jul 24, 2012
Start date
Jul 27, 2012
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015
Last update
Nov 28, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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