Alternating Icotinib and Chemotherapy for Advanced Non-small Cell Lung Cancer With EGFR Mutation

Phase 2

• Conditions: Lung Adenocarcinoma
• Interventions: Drug: Icotinib; Drug: Pemetrexed/Carboplatin

• Registration Number: NCT02737774
• Lead Sponsor: Henan Cancer Hospital

Brief Summary

This is a prospective, open, single-center, phase Ⅱ study to assess the efficacy and safety of alternating Icotinib and chemotherapy for advanced non-small cell lung cancer with EGFR mutation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-09
• Study Start: 2016-04-13
• Study First Posted: 2016-04-14
• Primary Completion: 2019-10-25
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-30
• Last Update Posted: 2020-07-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Histological or cytological confirmation of non-small cell lung cancer (NSCLC) in phase ⅢB or phase Ⅳ.
2. Positive EGFR mutation(19 exon or 21 exon)。

Exclusion Criteria

1. Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
2. Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
3. Allergic to icotinib
4. metastases of spinal cord, meninges or meningeal.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Icotinib and Pemetrexed/Carboplatin	Pemetrexed/Carboplatin	Icotinib: Icotinib for 18 weeks, 125mg Tid，PO. Chemotherapy: pemetrexed 500mg/m2 iv , 4 cycles. carboplatin AUC=5 iv ,4 cycles. Then continue with Icotinib, 125mg Tid，PO. until disease progression.
Icotinib and Pemetrexed/Carboplatin	Icotinib	Icotinib: Icotinib for 18 weeks, 125mg Tid，PO. Chemotherapy: pemetrexed 500mg/m2 iv , 4 cycles. carboplatin AUC=5 iv ,4 cycles. Then continue with Icotinib, 125mg Tid，PO. until disease progression.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	from the day confirmed NSCLC to the day of first detecting progression, up to 24 months

Secondary Outcome Measures

Name	Time	Method
overall survival time	from the day confirmed NSCLC to the day of death, up to 36 months

Trial Locations

Locations (1)

Henan cancer hospital; 🇨🇳 Zhengzhou, Henan, China