EGFR-TKI Combined With Concurrent or Sequential Chemotherapy for Patients of Gradual Progression
Condition: Lung Adenocarcinoma; EGFR Activating Mutation
MeSH terms: Adenocarcinoma of Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the efficacy of simultaneous EGFR-TKI and chemotherapy with that of sequential
      treatment after patients gradually progressed from first-line EGFR-TKI treatment.

      Patients who had gradual progression and EGFR-T790M mutation-negative were randomly divided
      into two groups: in concurrent group, patients were treated with pemetrexed plus cisplatin
      along with the same EGFR-TKI; in sequential group, patients continued with EGFR-TKI until the
      disease progressed again according to the RECIST criteria, and then switched to chemotherapy.
      We evaluated progression-free survival (PFS) and overall survival (OS) time of patients. For
      sequential group, PFS was PFS1 (gradual progression to discontinue EGFR-TKI) plus PFS2
      (chemotherapy alone).
    

Detailed description: 
      According to previous reports, when non-small cell lung cancer (NSCLC) patients with EGFR
      mutations gradually progressed after initial EGFR tyrosine-kinase inhibitor (TKI) treatment,
      continuing TKI therapy may be beneficial. We aimed to compare the efficacy of simultaneous
      EGFR-TKI and chemotherapy with that of sequential treatment after patients gradually
      progressed from first-line EGFR-TKI treatment.

      Patients who had gradual progression and EGFR-T790M mutation-negative were randomly divided
      into two groups: in concurrent group, patients were treated with pemetrexed plus cisplatin
      along with the same EGFR-TKI; in sequential group, patients continued with EGFR-TKI until the
      disease progressed again according to the RECIST criteria, and then switched to chemotherapy.
      We evaluated progression-free survival (PFS) and overall survival (OS) time of patients. For
      sequential group, PFS was PFS1 (gradual progression to discontinue EGFR-TKI) plus PFS2
      (chemotherapy alone). Objective response rate (ORR), disease control rate (DCR), overall
      survival (OS), and safety were also evaluated.
    

Intervention name(s): icotinib combined with pemetrexed plus cisplatin; first icotinib and then pemetrexed plus cisplatin
Intervention type(s): Drug; Drug
Intervention description(s): Continued using the icotinib (125 mg/time, 3 times/day every day) combined with Pemetrexed (500 mg/㎡ on day 1) plus cisplatin (75mg/m2 on day 1) and repeat every four weeks for up to six cycles and then continue to receive pemetrexed combined with icotinib every four weeks.; Continued using the icotinib (125 mg/time, 3 times/day every day)) alone until the investigator judged that continuation was adiaphorous, and switched to Pemetrexed (500 mg/㎡ on day 1) plus cisplatin (75mg/m2 on day 1) alone, repeat every four weeks for up to six cycles and then continue to receive pemetrexed every four weeks.
Other intervention name(s): EGFR-TKI combined with chemotherapy; chemotherapy
Intervention MeSH terms: Cisplatin; Pemetrexed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment