Non-small Cell Lung CancerPhase 2RECELNCT01714908
Phase II Study of Erlotinib With Concurrent Radiotherapy in Unresectable NSCLC With Activating Mutation of EGFR in Exon 19 or 21
A Phase 2 study testing Erlotinib w Concurrent Radiotherapy and etoposide/cis-platin (EP) w Concurrent Radiotherapy in people with Non-small Cell Lung Cancer, run by Jinming Yu at 19 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Erlotinib w Concurrent Radiotherapy and etoposide/cis-platin (EP) w Concurrent Radiotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 19 sitesChina
- Study dates
- 14 Dec 2012to 20 Oct 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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 locations and contacts
19 sites in 1 country.
19 sites in 1 country
China19 sites
Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality, 100853
West China Hospital, West China School of Medicine, Sichuan University
Chengdu, Sichuan, 610041
Fujian Province Cancer Hospital
Fuzhou, Fujian, 350008
Guizhou Cancer Hospital
Guiyang, Guizhou, 550004
The First People's Hospital of Hangzhou
Hangzhou, Zhejiang, 310006
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Shandong Cancer Hospital and Institute
Jinan, Shandong, 250117
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, 050011
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430030
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Henan Cancer Hospital
Zhengzhou, Henan, 450008
About this study
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
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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Erlotinib w Concurrent Radiotherapy, etoposide/cis-platin (EP) w Concurrent Radiotherapy
- Keywords
- NSCLC, EGFR mutation, unresectable, erlotinib, concurrent radiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erlotinib w Concurrent RadiotherapyOther
etoposide/cis-platin (EP) w Concurrent RadiotherapyOther
Etoposide / Cis-platin w Concurrent Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib w Concurrent Radiotherapy | Experimental | 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. Receives: Other: Erlotinib w Concurrent Radiotherapy |
| etoposide/cis-platin (EP) w Concurrent Radiotherapy | Active comparator | 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. Receives: Other: etoposide/cis-platin (EP) w Concurrent Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study start14 Dec 2012
- Primary completion20 Aug 2018 (estimated)
- Study completion20 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinming Yu
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor-investigator, Jinming Yu, Shandong Cancer Hospital and Institute
- Investigators
- Jinming Yu, PhD, Study chair, Shandong Cancer Hospital and InstituteShenglin Ma, PhD, Principal investigator, First People's Hospital of HangzhouConghua Xie, PhD, Principal investigator, Zhongnan HospitalMing Chen, PhD, Principal investigator, Zhejiang Cancer HospitalGang Wu, PhD, Principal investigator, Tongji Medical College, Huazhong University of Science and Technology, Wuhan Union HospitalJianhua Wang, PhD, Principal investigator, Henan Cancer HospitalJiancheng Li, PhD, Principal investigator, Fujian Province Cancer HospitalZhengfei Zhu, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714908
- Sponsor's protocol ID
- ML28545
- Acronym
- RECEL
- Status last verified
- Feb 2017
- First submitted
- 23 Oct 2012
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01714908
- Acronym / sponsor ID
- RECEL / ML28545
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- NSCLC, EGFR mutation, unresectable, erlotinib, concurrent radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jinming YuUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 14 Dec 2012 (actual)
- Primary completion
- 20 Aug 2018 (estimated)
- Study completion
- 20 Oct 2018 (estimated)
- First posted
- 26 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erlotinib w Concurrent Radiotherapy | Experimental | Other: Erlotinib w Concurrent Radiotherapyerlotinib 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/cis-platin (EP) w Concurrent Radiotherapy | Active comparator | Other: etoposide/cis-platin (EP) w Concurrent Radiotherapyetoposide 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erlotinib w Concurrent Radiotherapy | Other | Erlotinib w Concurrent Radiotherapy |
| etoposide/cis-platin (EP) w Concurrent RadiotherapyEtoposide / Cis-platin w Concurrent Radiotherapy | Other | etoposide/cis-platin (EP) w Concurrent Radiotherapy |
Primary outcome
Progress Free Survival (PFS)
Time frame: 5 years
The time frame from the randomization to the first confirmed disease progression or any cause to death (dependent on which comes first)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinming Yu, PhD study chair
Shandong Cancer Hospital and Institute
Shenglin Ma, PhD principal investigator
First People's Hospital of Hangzhou
Conghua Xie, PhD principal investigator
Zhongnan Hospital
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erlotinib w Concurrent Radiotherapy and etoposide/cis-platin (EP) w Concurrent Radiotherapy in people with Non-small Cell Lung Cancer, run by Jinming Yu at 19 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress Free Survival (PFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.