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

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

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

Study Overview

• Status: Unknown
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: docetaxel; Drug: pemetrexed; Drug: Erlotinib

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Cancer hospital Fudan University
      • Contact: Chang J hua, PD; Phone Number: 13916619284; Email: changjianhua@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: combination with Erlotinib; Erlotinib 150mg qd combination with docetaxel 75mg/m2 or pemetrexed 500mg/m2	Drug: docetaxel; docetaxel 75mg/m2 ivgtt D1; Drug: pemetrexed; pemetrexed 500mg/m2 ivgtt D1; Drug: Erlotinib; Erlotinib 150mg qd
Active Comparator: sequential chemotherapy for Erlotinib; docetaxel 75mg/m2 or pemetrexed 500mg/m2，after PD，Erlotinib 150mg qd	Drug: docetaxel; docetaxel 75mg/m2 ivgtt D1; Drug: pemetrexed; pemetrexed 500mg/m2 ivgtt D1; Drug: Erlotinib; Erlotinib 150mg qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival (PFS)	from the first cycle of treatment (day one) to two month after the last cycle

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Chang J hua, PD, Fudan University

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: January 2, 2014
• First Submitted That Met QC Criteria: January 15, 2014
• First Posted (Estimate): January 16, 2014

Study Record Updates

• Last Update Posted (Estimate): February 23, 2016
• Last Update Submitted That Met QC Criteria: February 22, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: PFS
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Protein Kinase Inhibitors; Folic Acid Antagonists; Docetaxel; Erlotinib Hydrochloride; Pemetrexed
• Other Study ID Numbers: CJH-Erlotinib-2013