Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma

Conditions

Adenocarcinoma, EGFR Positive Non-small Cell Lung Cancer

Brief summary

The purpose of this study is to compare 3years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.

Detailed description

This study is designed to compare 3 years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma. Primary Outcome Measure: Disease-free survival between Icotinib group and placebo group. Secondary Outcome Measures: Overall survival between Icotinib group and placebo group. Lung cancer symptoms and health-related quality of life (HRQoL) . Number of participants with adverse events.

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

Adjuvant Osimertinib for Resected EGFR-Mutated Stage IB-IIIA Non–Small-Cell Lung Cancer: Updated Results From the Phase III Randomized ADAURA Trial

Roy S. Herbst, Yi‐Long Wu, Thomas John, Christian Grohé, Margarita Majem et al. (25 authors)

Journal of Clinical Oncology2023-01-31346 citations

10.1200/jco.22.02186

<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

DRUGIcotinib

125 mg three times daily (375 mg per day) by mouth

DRUGPlacebo

1 tablet three times daily by mouth

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

* Pathologically confirmed lung adenocarcinoma after surgical resection * Stage II-IIIA disease according to 7th edition of TNM staging * Patients must harbor sensitive EGFR gene mutation (19/21) * Received four cycles of platinum-based adjuvant chemotherapy.There are many different kinds of chemotherapy regimens including vinorelbine, gemcitabine, docetaxel, paclitaxel, pemetrexed plus cisplatin or carboplatin.The first cycle of chemotherapy with cisplatin dose of 75 mg / m2 ± 10% or carboplatin AUC = 5 ± 10% to calculate the dose of chemotherapy

Exclusion criteria

* Previous systemic anti-tumor therapy, including chemotherapy or targeted therapy(Including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitor, etc * Presence of metastatic disease * Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ * Any unresolved chronic toxicity from previous anticancer therapy * Received antitumor radiation therapy (except for the stage IIIA N2 patients who received adjuvant radiotherapy after surgery)

Design outcomes

Primary

Measure	Time frame	Description
Disease-free survival	36 months	DFS was defined as the time from the date of first dose of study medication to the date of death due to disease recurrence or disease progression.

Secondary

Measure	Time frame	Description
Overall survival	60 months	OS was assessed via calculation of the time to death due to any cause from the date of randomization. A patient was censored at the last date they were known to be alive.
Lung cancer symptoms and health-related quality of life (HRQoL) differences	60 months	—
Number of participants with adverse events	36 months	—

Countries

China

Contacts

Primary ContactYuan-Kai Shi, MD

010-87788293

Outcome results

None listed