Second Line Erlitinib Combination With Gemcitabine Cisplatinum in Non-small Cell Lung Cancer Patients Who Harbored EGFR Sensitive Mutation Developed Resistance After First Line TKI Treatment

Who is this study for? Patients with non-small cell lung cancer who harbored EGFR sensitive mutation developed resistance after frst line TKI treatment
What treatments are being studied? Gemcitabine platinum+Erlotinib
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Numerous evidences verified that erlotinib could dramatically improve the PFS and OS of non-small cell lung cancers who harbor EGFR sensitive mutations, however, primary or secondary resistance will be developed after TKI treatment, doctors do plenty of researches to overcome TKI resistance. FAST ACT-2 study present that, first line erlotinib combined with chemotherapy could improved mOS to more than 30 months in NSCLCs who harbor EGFR sensitive mutations, several study shows that sensitive mutations still exist after TKI resistance, because of the next generation TKIs(such as BIBW2992) are not avaliable at present, agents for met amplification(such as Crizotinib) are so expensive that many Chinese patients could not support. Thus, the investigators hypothesis that, after first line TKI treatment, the patients who developed TKI resistance could still benefit from second line TKI combined with chemotherapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• advanced non-small cell lung cancer, stage IIIB/IV

• non-squamous

• EGFR sensitive mutations, such as exon 19 del, or exon 21 L858R

• received first line TKIs treatment and developed TKI resistance

• ECOG 0-2

Locations
Other Locations
China
Hunan Province Tumor Hospital
RECRUITING
Changsha
Contact Information
Primary
Nong Yang, MD
yangnong0217@163.com
+86 731 89762323
Backup
Ming Zhou, MD
zhouming243@163.com
+86 731 89762320
Time Frame
Start Date: 2014-07-01
Estimated Completion Date: 2025-12-12
Participants
Target number of participants: 40
Treatments
Experimental: experimental
patients will received a 28 days gemcitabine platinum combined with erlotinib scheme(gemcitabine for day 1 and day 8, 1250mg/m2. Platinum for day 1, 75mg/m2. Erlotinib for 150mg/day, day 9-21 every cycle, after 4 cycles, erlotinib should be used daily), after 4 cycle of combined chemotherapy, patients will receive erlotinib for further treatment until progression disease.
Sponsors
Leads: Hunan Province Tumor Hospital

This content was sourced from clinicaltrials.gov