Phase II Study of Erlotinib With Concurrent Radiotherapy in Unresectable NSCLC With Activating Mutation of EGFR in Exon 19 or 21

A Multicenter, Randomized, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Erlotinib Versus Etoposide Plus Cisplatin With Concurrent Radiotherapy in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) With Activating Mutation of Epidermal Growth Factor Receptor (EGFR) in Exon 19 or 21

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01714908

Acronym

RECEL

Enrollment

100

Registered

2012-10-26

Start date

2012-12-14

Completion date

2018-10-20

Last updated

2017-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLC, EGFR mutation, unresectable, erlotinib, concurrent radiotherapy

Brief summary

Erlotinib with concurrent radiotherapy has superior efficacy and comparable safety profile in unresectable stage III non-small cell lung cancer (NSCLC) patients with activating mutation of epidermal growth factor receptor (EGFR) in exon 19 or 21 versus etoposide plus cis-platin with concurrent radiotherapy.

Interventions

OTHERErlotinib w Concurrent Radiotherapy

OTHERetoposide/cis-platin (EP) w Concurrent Radiotherapy

Etoposide / Cis-platin w Concurrent Radiotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* NSCLC confirmed by histopathology or cytology; * Stage IIA or IIIB NSCLC according to Tumor Node Metastasis (TMN) staging of Lung Staging Standard version 7 2009, and be unresectable; * Has active mutation of EGFR in exon 19 or 21; * Has measurable lesion \[according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, must have at least one evaluable lesion with the longest dimension \>= 10mm; if the evaluable lesion is lymph node, the shortest dimension should be measured and \>=15mm\]; * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1; * expectancy life \>= 12 weeks;

Exclusion criteria

* Had be treated by HER-targeting agents; * Had systemic anit-NSCLC treatments; * Had local radiotherapy for NSCLC; * Has upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer; * Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival, cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor); * Any evidence to indicate moderate or severe chronic obstructive pulmonary disease (COPD); * Known hypersensitivity to platinum, etoposide, EGFR-Tyrosine Kinase Inhibitor (TKI) agents or relevant components in the formulation; * Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection;

Design outcomes

Primary

Measure	Time frame	Description
Progress Free Survival (PFS)	5 years	The time frame from the randomization to the first confirmed disease progression or any cause to death (dependent on which comes first)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026