Know Cancer

or
forgot password

A Randomized Phase II Study Comparing Pemetrexed Plus Cisplatin With Gemcitabine Plus Cisplatin According to Thymidylate Synthase Expression in Non-squamous Non-small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

Thank you

Trial Information

A Randomized Phase II Study Comparing Pemetrexed Plus Cisplatin With Gemcitabine Plus Cisplatin According to Thymidylate Synthase Expression in Non-squamous Non-small Cell Lung Cancer


Inclusion Criteria:



- Histologically confirmed nonsquamous NSCLC

- Stage IIIb, IV or recurrent NSCLC

- Age ≥ 18years

- ECOG performance status of 0 to 1

- Known TS immunohistochemical analysis data

- At least one measurable lesion by RECIST 1.1

- No previous chemotherapy or therapy with EGFR TKIs for advanced NSCLC

- Asymptomatic brain metastasis or symptomatic brain metastasis treated with local
treatment such as operation, whole brain radiotherapy, or gamma-knife surgery

- At least 2 weeks later after whole brain radiotherapy or palliative radiotherapy

- Adequate renal function: estimated creatinine clearance ≥ 50mL/min

Exclusion Criteria:

- Patients whose disease recurred within 6 months after the completion of adjuvant
chemotherapy.

- Patients with post-obstructive pneumonia or uncontrolled serious infection

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

predictive value of TS expression

Outcome Description:

To determine the predictive value of thymidylate synthase expression in NSCLC patients treated with pemetrexed combination therapy by interaction P value

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Myung-Ju Ahn, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

2011-06-006

NCT ID:

NCT01401192

Start Date:

July 2011

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • thymidylate synthase
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location