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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02037997

Enrollment

Registered

2014-01-16

Start date

2013-12-31

Completion date

2017-12-31

Last updated

2016-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Keywords

PFS

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

Interventions

DRUGdocetaxel

docetaxel 75mg/m2 ivgtt D1

DRUGpemetrexed

pemetrexed 500mg/m2 ivgtt D1

DRUGErlotinib

Erlotinib 150mg qd

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactChang J hua, PD

changjianhua@163.com13916619284

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026