Clinical trial · Interventional
Genotype-Driven Treatment of Advanced Non-small Cell Lung Cancer Based on mRNA Expression of ERCC1 & RRM1 as First-line Chemotherapy
NCT01648517CI-TRIAL-00030537completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy | Drug | Chemotherapy | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- 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)
- interventionNames
- Drug: chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- standard of care All control arm patients received standard platinum-based doublet chemotherapy with docetaxel plus carboplatin
- interventionNames
- Drug: chemotherapy
Primary outcomes (1)
- measure
- overall Response Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHeo 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. PMID 26811178