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

Non-small Cell Lung Carcinoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01648517
• Other study ID #: 4-2008-0132
• Status: Completed
• Phase: Phase 2
• First received: July 1, 2012
• Last updated: November 26, 2017
• Start date: July 27, 2012
• Est. completion date: June 30, 2015

Study information

• Verified date: November 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2015
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Carcinoma

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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	Progression free survival		up to 4 years
Secondary	overall survival		up to 4 years
Secondary	duration of response		up to 4 years
Secondary	disease control rate		up to 4 years