Icotinib as Adjuvant Therapy in Treating Non-small-cell Lung Cancer Patients With Positive EGFR Mutation

Conditions

Non-small-cell Lung Cancer

Brief summary

This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating such patients. The primary endpoint is to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib.

Detailed description

Adjuvant therapy has been proved effective in treating stage II-IIIA non-small-cell lung cancer. However, few data on the treating time of adjuvant therapy is available. Here we conduct a randomized, prospective study to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib in EGFR-mutated non-small cell lung cancer patients.

Lv C, Wang R, Li S, Yan S, Wang Y, Chen J, Wang L, Liu Y, Guo Z, Wang J, Pei Y, Yu L, Wu N, Lu F, Gao F, Chen J, Liu Y, Wang X, Li S, Han B, Zhang L, Ma Y, Ding L, Wang Y, Yuan X, Yang Y.

2023-06-209 citations

10.1016/j.esmoop.2023.101565

Different exposure duration of adjuvant icotinib in stage II-IIIA non-small cell lung cancer patients with positive EGFR mutation (ICOMPARE study): A randomized, open-label phase 2 study.

Chao Lyu, Rui Wang, Shaolei Li, Yan Shi, Yuzhao Wang et al. (20 authors)

Journal of Clinical Oncology2021-05-208 citations

10.1200/jco.2021.39.15_suppl.8521

<p>Icotinib as Adjuvant Treatment for Stage II-IIIA Lung Adenocarcinoma Patients with EGFR Mutation (ICWIP Study): Study Protocol for a Randomised Controlled Trial</p>

Yutao Liu, Xuezhi Hao, Deruo Liu, Gang Cheng, Shucai Zhang et al. (17 authors)

Cancer Management and Research2020-06-0110 citations

10.2147/cmar.s240275

Interventions

DRUG1-year treatment with icotinib

Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 1 year.

DRUG2-year treatment with icotinib

Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 2 years.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

* The patients signed the written informed consent * The patients present with operable stage II-IIIA non-small-cell lung cancers with 19 or 21 exon mutation * The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy * The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2

Exclusion criteria

* Patients with unresected tumor * Wild EGFR type * Allergic to the study drug * Patients have severe non-cancerous diseases * Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials

Design outcomes

Primary

Measure	Time frame
Recurrence-free Survival	6 months

Secondary

Measure	Time frame
Overall survival	6 months

Countries

China

Contacts

Primary ContactYue Yang, MD

zlyangyue@bjmu.edu.cn86-10-88196568

Outcome results

None listed