Targeted Treatment With Intercalated Radiotherapy in EGFR-mutant IIIA/IIIB NSCLC

Sponsor
Guangdong Provincial People's Hospital
Study ID
NCT03074864
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib Hydrochloride — DRUG
    Subjects receive erlotinib tablet 150mg orally once daily, after 12 weeks of induction phase, local radiotherapy is intercalated, and followed by 24-week erlotinib maintenance phase. At the end of maintenance, the subjects enter into the follow-up period.

Study Details

The aim of this study is to investigate the efficacy and safety of intercalated combination of erlotinib and radiotherapy for patients with EGFR-mutant, unresectable, locally advanced NSCLC, and to explore a new treatment strategy for this subset. After Induction by erlotinib, local radiotherapy is intercalated, and followed by 24-week erlotinib maintenance.

Key Dates

First listed
Mar 9, 2017
Start date
Feb 27, 2017
Status verified
Mar 2017
Primary completion
Jun 30, 2019
Completion
Jun 30, 2020

Study Design

Enrollment
90 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: EGFR-mutant IIIA/IIIB NSCLC
    Erlotinib Hydrochloride 150mg daily intercalated with radiotherapy

Primary Outcome Measure

Objective response rate [ Time Frame: Tumor response will be evaluated through study completion, an average of 6 weeks. ]

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