Clinical trial NCT02037997: Safety and Effectiveness Study of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With NSCLC
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: PFS
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: from the first cycle of treatment (day one) to two month after the last cycle
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cancer hospital Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Chang J hua, PD
role: PRINCIPAL_INVESTIGATOR
References: