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A Phase Ⅱ Randomized Controlled Trial to Compare Gefitinib With Docetaxel as Second-line Therapy for Advanced or Metastatic Non-squamous NSCLC Patients With Wild-type EGFR


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

A Phase Ⅱ Randomized Controlled Trial to Compare Gefitinib With Docetaxel as Second-line Therapy for Advanced or Metastatic Non-squamous NSCLC Patients With Wild-type EGFR


The adoption of docetaxel as a standard second line therapy was based on data from two phase
Ⅲ trials. In the first trail, docetaxel (75mg/m2, every 3 weeks) significantly prolonged
median and 1-year survival duration compared with best supportive care (median survival, 7.5
months versus 4.6 months; P=0.010; 1-year survival, 37% versus 12%), although the response
rate was low (5.5%). In the second study the 6-months and median survival rates were similar
for docetaxel and vinorelbine or ifosfamide. However, the 1-year survival rate was
significantly greater with docetaxel than ifosfamide or vinorelbine (32% versus 19%,
P=0.025). In both studies docetaxel significantly improved some parameters of quality of
life. Since these two pivotal studies, new potential second-line drugs were compared with
the docetaxel standard of care. With regards to the therapeutic results of the docetaxel arm
of these studies, it must be emphasized that response rates and survival data were highly
and significantly reproducible.


Inclusion Criteria:



- Age more than 18 years old

- Life expectancy more than 12 weeks

- histologically or cytologically confirmed inoperable non-squamous NSCLC (stage ⅢB/Ⅳ)

- ineligible for curative radiotherapy

- no prior radiotherapy for the target lesions

- Eastern Cooperative Oncology Group (ECOG) performance score of 0-2

- previous treatment include first-line platinum doublet chemotherapy

- no EGFR gene mutation detected by Scorpions-ARMS

- at least one bidimensionally measurable or radiographically assessable lesion

- adequate bone marrow reserve

- adequate hepatic and renal function

Exclusion Criteria:

- prior treatments including any of the following drugs: gefitinib and docetaxel

- additional malignancies

- uncontrolled systemic disease

- any evidence of clinically active interstitial lung disease

- newly diagnosed central nervous system (CNS)metastasis and not treated by
radiotherapy of surgery

- pregnancy or breast feeding phase

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression free survival

Outcome Description:

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.

Outcome Time Frame:

up to 52 weeks (about one year)

Safety Issue:

No

Principal Investigator

Mengzhao Wang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peking Union Medical College Hospital

Authority:

China: Food and Drug Administration

Study ID:

PUMCH-S466

NCT ID:

NCT01755923

Start Date:

December 2012

Completion Date:

December 2014

Related Keywords:

  • Non-Small Cell Lung Cancer
  • non-small cell lung cancer
  • wild-type EGFR
  • gefitinib
  • docetaxel
  • second-line therapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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