Safety and Effectiveness Study of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With NSCLC
NCT ID: NCT02037997
Last Updated: 2016-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2013-12-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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combination with Erlotinib
Erlotinib 150mg qd combination with docetaxel 75mg/m2 or pemetrexed 500mg/m2
docetaxel
docetaxel 75mg/m2 ivgtt D1
pemetrexed
pemetrexed 500mg/m2 ivgtt D1
Erlotinib
Erlotinib 150mg qd
sequential chemotherapy for Erlotinib
docetaxel 75mg/m2 or pemetrexed 500mg/m2，after PD，Erlotinib 150mg qd
docetaxel
docetaxel 75mg/m2 ivgtt D1
pemetrexed
pemetrexed 500mg/m2 ivgtt D1
Erlotinib
Erlotinib 150mg qd
Interventions
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docetaxel
docetaxel 75mg/m2 ivgtt D1
pemetrexed
pemetrexed 500mg/m2 ivgtt D1
Erlotinib
Erlotinib 150mg qd
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Chang Jian Hua
attending
Principal Investigators
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Chang J hua, PD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Cancer hospital Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CJH-Erlotinib-2013
Identifier Type: -
Identifier Source: org_study_id
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