CI

At a glance

ClinicalIndex Comparison Record
Phase 3Unknown· 320 target
Drug / intervention
Icotinib +1 moredrug
Likely dose
Icotinib 125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02448797
NCT02448797Phase 3Unknown
CompareCT.gov

Icotinib as Adjuvant Therapy Compared With Standard Chemotherapy in Stage II-IIIA Non-small Cell Lung Cancer With EGFR-mutation: a Randomized, Positive-controlled, Phase 3 Study (EVIDENCE, CCTC-1501)

Betta Pharmaceuticals Co., Ltd.·interventional·Posted May 19, 2015·Updated Jul 20, 2021

In Brief

A Phase 3 clinical trial evaluating Icotinib and Chemotherapy for Non-small Cell Lung Cancer. Targeting 320 participants across 8 sites.

Detailed Summary

Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage II-IIIA non-small cell lung cancer patients with EGFR mutation. The primary endpoint is disease-free survival.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer
CountriesChina
Collaborators--

Timeline

Phase 3UnknownOverdue
20162017201820192020202120222023202420252026
First PostedMay 19, 2015
Enrollment StartJun 8, 2015
Primary CompletionJun 30, 2022
Study CompletionDec 1, 2023
TodayJul 1, 2026
Enrollment to primary: 7.1 yearsPosted 11.1 years ago

Interventions

Icotinibdrug

125 mg three times daily (375 mg per day) orally for two years.

Chemotherapydrug

Vinorelbine 25 mg/m\^2, intravenously guttae, day 1 and day 8, 21 days/cycle, 4 cycles, cisplatin 75 mg/m\^2, intravenously guttae, day 1, 21 days/cycle, 4 cycles. For adenocarcinoma: pemetrexed (500 mg/m\^2, day 1)/cisplatin (75 mg/m\^2, day 1) for 4 cycles.