Safety and Effectiveness Study of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With NSCLC

Non Small Cell Lung Cancer Clinical Trial

Official title:

Chemotherapy in Combination With Erlotinib, or Sequential Chemotherapy for Erlotinib for Treatment, EGFR - TKI Resistance of EGFR Mutations in Patients With NSCLC Randomized Controlled Phase II Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02037997
• Other study ID #: CJH-Erlotinib-2013
• Status: Recruiting
• Phase: Phase 2
• First received: January 2, 2014
• Last updated: February 22, 2016
• Start date: December 2013
• Est. completion date: December 2017

Study information

• Verified date: February 2016
• Source: Fudan University
• Contact: Chang J hua, PD
• Phone: 13916619284
• Email: changjianhua[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate and compare safety and effectiveness of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With EGFR - TKI Resistance of EGFR Mutations

Description:

from the first cycle of treatment (day one) to two month after the last cycle

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Sign the informed consent

2. =18 years

3. According to RECIST 1.1 standard, at least one measurable lesions

4. Histology and cytology confirmed with unfavorable surgical locally advanced stage (stage IIIB) or metastatic NSCLC (IV), Sensitive EGFR gene mutation

5. Palliative treatment has received two medicine first-line platinum-based chemotherapy and EGFR - TKI second-line treatment and objective clinical benefit (CR, PR or SD is more than 6 months), RESIST standard curative effect evaluation for progress

6. PS=0,1,2

7. No serious blood, heart, lung, liver and kidney dysfunction, and immune deficiency

8. Hb=9g/dL;WBC=3*109/L,ANC=1.5*109/L,PLT=75*109/L

9. Men or women of childbearing age in the experiment are willing to take contraceptive measures

10. Estimated survival period for 3 months or more

Exclusion Criteria:

1. The palliative chemotherapy ever use docetaxel and pemetrexed

2. small cell lung cancer non small cell hybrid

3. Women during pregnancy or lactation

4. In the past the anti-tumor treatment of any outstanding ease of > CTCAE 2 levels of toxicity

5. Ccr<30 ml/min (calculated by Cockcroft-Gault formula)

6. hepatic insufficiency: Tbil> 1.5×ULN ALT and AST > 2.5×ULN (Patients with liver metastasis>5×ULN) Alkaline phosphatase>2.5 ×ULN(Patients with liver metastasis>5×ULN)

7. Severe symptomatic heart disease

8. Symptomatic brain metastases

9. In the last 5 years have been or are suffering from other histological types of malignant tumor

10. There are serious or uncontrolled systemic diseases

11. During the study period planned radiotherapy on target lesion

12. During the study period, plans to use other antineoplastic therapy

13. Clinical study on treatment of 30 days beginning period prior to participate in any study drug

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Drug:
• docetaxel
docetaxel 75mg/m2 ivgtt D1
• pemetrexed
pemetrexed 500mg/m2 ivgtt D1
• Erlotinib
Erlotinib 150mg qd

Locations

Country	Name	City	State
China	Cancer hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)		from the first cycle of treatment (day one) to two month after the last cycle	Yes