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

Primary Purpose

Non-small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Erlotinib w Concurrent Radiotherapy

etoposide/cis-platin (EP) w Concurrent Radiotherapy

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring NSCLC, EGFR mutation, unresectable, erlotinib, concurrent radiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Beijing Cancer Hospital
Chinese PLA General Hospital
The General Hospital of the People's Liberation Army
Fujian Province Cancer Hospital
The First Affiliated Hospital of Xiamen University
Guizhou Cancer Hospital
Hebei Medical University Fourth Hospital
Henan Cancer Hospital
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Zhongnan Hospital of Wuhan University
Renmin Hospital of Wuhan University
The First Hospital of China Medical University
Shandong Cancer Hospital and Institute
Fudan University Shanghai Cancer Center
West China Hospital, West China School of Medicine, Sichuan University
Tianjin Medical University Cancer Institute and Hospital
The First People's Hospital of Hangzhou
Zhejiang Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Erlotinib w Concurrent Radiotherapy

etoposide/cis-platin (EP) w Concurrent Radiotherapy

Arm 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.

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.

Outcomes

Primary Outcome Measures

Progress Free Survival (PFS)

The time frame from the randomization to the first confirmed disease progression or any cause to death (dependent on which comes first)

Secondary Outcome Measures

Full Information

NCT ID

NCT01714908

First Posted

October 23, 2012

Last Updated

February 4, 2017

Sponsor

Jinming Yu

Collaborators

Roche Pharma AG

1. Study Identification

Unique Protocol Identification Number

NCT01714908

Brief Title

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

Acronym

RECEL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Unknown status

Study Start Date

December 14, 2012 (Actual)

Primary Completion Date

August 20, 2018 (Anticipated)

Study Completion Date

October 20, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jinming Yu

Collaborators

Roche Pharma AG

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

Keywords

NSCLC, EGFR mutation, unresectable, erlotinib, concurrent radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Erlotinib w Concurrent Radiotherapy

Arm Type

Experimental

Arm 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.

Arm Title

etoposide/cis-platin (EP) w Concurrent Radiotherapy

Arm Type

Active Comparator

Arm 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.

Intervention Type

Other

Intervention Name(s)

Erlotinib w Concurrent Radiotherapy

Intervention Type

Other

Intervention Name(s)

etoposide/cis-platin (EP) w Concurrent Radiotherapy

Intervention Description

Etoposide / Cis-platin w Concurrent Radiotherapy

Primary Outcome Measure Information:

Title

Progress Free Survival (PFS)

Description

The time frame from the randomization to the first confirmed disease progression or any cause to death (dependent on which comes first)

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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;

Overall Study Officials: