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Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Treatment Active Over 18 Other, Pharmaceutical / Industry D7913L00071 NCT00769639

Trial Description

Summary

This is a multi-center phase IV randomized controlled study to assess the efficacy of patients with IIIB/IV staged non-small cell lung cancer(NSCLC) without tumor progression after first-Line Platinum-based chemotherapy to receive Gefitinib by PFS,OS,ORR And DCR.The safety is evaluated as well.

Eligibility Criteria

Inclusion Criteria:

1. Signed and dated informed consent before the start of specific protocol procedures.

2. Age >18 years, either sex

3. Life expectancy > 12 weeks

4. Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology)

5. WHO performance status(PS)<= 2 ( Patients Whit PS=2 Should not get worsen within 2 weeks Before Included)

6. without progressional disease after receiving 4 Cycles two-drug platinum-based chemotherapy regimen. Allowable regimens are listed as follows:Carboplatin AUC 5.0-6.0 or Cisplatin 75-100mg/m2 on day 1 every 3 weeks combined with Gemcitabine 1000-1250mg/m2 on day 1 and 8 every 3 weeks,Docetaxel 60-75mg/m2 on day 1 every 3 weeks,Taxel 175-225mg/m2 on day 1 every 3 weeks,or vinorelbine 25-30mg/m2 on day 1 and 8 every 3 weeks.The interval between the 1st day of the 1st and the 4th cycle must be less than 15 weeks(105 days) tO ensure dose intensity.

7. with a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT) and >=20mm with conventional CT) at least according to RECIST Criteria

8. last Chemotherapy is administrated 3-6 weeks (21-42 days) and therapeutic efficacy of last Chemotherapy regimen is evaluated 4 weeks(28 days) Before receiving our trial therapy.

9. More Than 6 months after having completed adjuvant or Neo-adjuvant Chemotherapy Patients received fist-line chemotherapy without progression.Those Patients Can Be Included.

10. Patients able to taken oral drug

Exclusion Criteria:

1. staffs of either AstraZeneca or research institution involved in the study.

2. experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as Gefitinib,erotinib or Cetuximab.

3. Prior exposure to drugs without approval from this research or other study drugs within 42 days before the 1st day taken Gefitinib/Placebo.

4. plasma bilirubin >3 times the upper limit of normal.

5. Aspartate transaminase (AST) and alanine transaminase (ALT)> 2.5 x upper limit of normal (> 5 x upper limit of normal for patients with liver involvement of their cancer).

6. Patients who have been suffering from any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 toxicity developed by Anticancer Therapy except of neurotoxicity.

7. Patients with metastatic brain tumors or spinal compression who are clinically stable with respect to the tumor and > 4 weeks from hormone therapy at the time of initial Gefitinib/Placebo therapy may allow entry.

8. patients clinically proven of interstitial lung disease (except of patients with chronic and stable imaging without specific symptom).

9. CT scan of baseline providing with evidence of idiopathic pulmonary fibrosis.

10. Patients receiving radical resection after first-line Platinum-Based Chemotherapy.

11. Severe systemic disease out of control such as unstable or uncompensatory respiratory,cardiac,liver,renal diseases.

12. Receiving any chemotherapy regimen not specified by inclusion criteria. Patients receiving palliative irradiation for metastatic lesion to relieve the symptoms could be included, except of patients receiving radiation on lung which cannot be completed within 4 weeks before study entry or with sustained radiotherapy relative toxicity.

13. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except of cervical carcinoma in situ,basal cell carcinoma within 5 years prior to study entry.

14. Pregnant or breast-feeding women.Women of childbearing potential enrolled in this trial must use adequate barrier birth control measures during the course of the trial.

15. current treatment with phenytoin sodium,carbamazepine,rifampicin,barbital or St.John's Wort.

16. Patients previously entried this trial or received study drug.

17. previous bone marrow transplantation.

18. whole blood transfusion within 120 days prior to genetic sample collection.

19. exposure of information from biomarkers listed as follow:EGFR gene copy number, status of EGFR mutation and EGFR expression by the protein.

Trial Contact Information

Trial Lead Organizations/Sponsors

Sun Yat-Sen University First Hospital

Zhang Li, Master

Principal Investigator

Li Zhang, MD		Ph: 86-20-87343458
		Email: zhangli6@mail.sysu.edu.cn

China
	Guangzhou
	Sun Yat-Sen University Cancer Center
		Li Zhang, MD	Ph: 86-20-87343458
			Email: zhangli6@mail.sysu.edu.cn
		Li Zhang, MD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00769639
Information obtained from ClinicalTrials.gov on October 09, 2008