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

Study Overview
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Brief Summary
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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

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

Official Title
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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

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: docetaxel
* Drug: pemetrexed
* Drug: Erlotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign the informed consent ≥18 years According to RECIST 1.1 standard, at least one measurable lesions Histology and cytology confirmed with unfavorable surgical locally advanced stage (stage IIIB) or metastatic NSCLC (IV), Sensitive EGFR gene mutation 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 PS=0,1,2 No serious blood, heart, lung, liver and kidney dysfunction, and immune deficiency Hb≥9g/dL；WBC≥3*109/L，ANC≥1.5*109/L，PLT≥75*109/L Men or women of childbearing age in the experiment are willing to take contraceptive measures Estimated survival period for 3 months or more Exclusion Criteria: The palliative chemotherapy ever use docetaxel and pemetrexed small cell lung cancer non small cell hybrid Women during pregnancy or lactation In the past the anti-tumor treatment of any outstanding ease of > CTCAE 2 levels of toxicity Ccr<30 ml/min (calculated by Cockcroft-Gault formula) 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) Severe symptomatic heart disease Symptomatic brain metastases In the last 5 years have been or are suffering from other histological types of malignant tumor There are serious or uncontrolled systemic diseases During the study period planned radiotherapy on target lesion During the study period, plans to use other antineoplastic therapy Clinical study on treatment of 30 days beginning period prior to participate in any study drug

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PFS