NOV120101 Phase 2 Study in NSCLC Patients With Aquired Resistance to 1st Generation EGFR Tyrosine… (NCT01718847) | Clinical Trial Compass
CompletedPhase 2
NOV120101 Phase 2 Study in NSCLC Patients With Aquired Resistance to 1st Generation EGFR Tyrosine Kinase Inhibitors
South Korea40 participantsStarted 2013-01
Plain-language summary
The purpose of this open-label, single-arm, multi-center phase II trial is to evaluate the efficacy and safety of novel pan-HER inhibitor, NOV120101 (Poziotinib), as a 2nd line monotherapy agent in lung adenocarcinoma patients with acquired resistance to prior EGFR tyrosine kinase inhibitors (TKIs).
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Male or female patients aged 20 years or older
✓. Pathologically confirmed stage IIIB (unresectable) or IV lung adenocarinoma
✓. Patients who have 1 or more than 1 measurable or evaluable but unmeasurable lesions according to RECIST ver1.1
✓. Patients who received prior 1st generation EGFR TKIs (gefitinib or erlotinib) monotherapy and meet the following criteria:
✓. Patients with EGFR mutation (e.g., G719X, exon 19 deletion, L858R, L861Q, etc) known to be associated with sensitivity to TKIs
✓. Patients who showed objective clinical benefit from treatment with an EGFR TKI as defined by either:
✓. Patients who showed progressive disease (PD, RECIST ver1.1) while on continuous treatment with gefitinib or erlotinib within the last 30 days (However, patients whose progressive disease is limited in the brain cannot participate in this trial.)
✓. No intervening systemic chemotherapy between cessation of the EGFR TKI and participation of this study
Exclusion criteria
✕. Patients who receive IP within 3 days from prior treatment with gefitinib or erlotinib
✕. NCI-CTCAE grade \> 1 adverse events due to treatment with gefitinib or erlotinib
✕. Prior systemic chemo, immuno, hormonal and/or biological therapy except gefitinib or erlotinib within 4 weeks before IP administration
What they're measuring
1
Progression free survival (PFS)
Timeframe: By 1 year after enrollment of the last subject
✕. Acquired resistance to EGFR TKI due to conversion of adenocarcinoma into small cell lung cancer
✕. Patients who received major surgery within 4 weeks before IP administration
✕. Symptomatic CNS metastases (patients with radiologically and neurologically stable metastases and being off corticosteroids for at least 4 weeks are able to participate in this trial.)
✕. History of other malignancies except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for ≥ 3 years and considered to be cured by investigator's judgment
✕. Known pre-existing interstitial lung disease (ILD)