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

Jinming Yu

Status and phase: Unknown; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Other: Erlotinib w Concurrent Radiotherapy; Other: etoposide/cis-platin (EP) w Concurrent Radiotherapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01714908

ML28545

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Erlotinib w Concurrent Radiotherapy

Experimental group

Description:

erlotinib 150mg oral daily up to 2 years concurrent radiotherapy total dose 60-66 Gray (Gy) in 2 Gray (Gy) fractions. One fraction per day, and 5 fractions per week.

Treatment:

Other: Erlotinib w Concurrent Radiotherapy

etoposide/cis-platin (EP) w Concurrent Radiotherapy

Active Comparator group

Description:

etoposide 50mg/m2 on D1-5 and D29-33 cis-platin 50mg/m2 on D1, D8, D29 and D36 concurrent radiotherapy total 60-66 Gray (Gy) in 2 Gray (Gy) fractions. One fraction per day, 5 fractions per week.

Treatment:

Other: etoposide/cis-platin (EP) w Concurrent Radiotherapy