Erlotinib Combined With Chemotherapy in TKI Resistant Non-Small Cell Lung Cancers

• Status: Recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hunan Province Tumor Hospital
• Treatments: Erlotinib Hydrochloride; Gemcitabine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• squamous non-small cell lung cancer

• patients have unstable brain metastasis, predict survival less than 8 weeks

• spinal-cord compression without evidence of stabilisation or treatment

• women who were pregnant or lactating; women with a positive or no available pregnancy test result at baseline

• patients have any unstable illness that could not receive further treatment