UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000015949
Receipt No. R000018280
Scientific Title A Prospective, Multi-center Phase II Trial on the Efficacy and Safety of Low-dose Erlotinib Monotherapy for Frail Patients with EGFR Mutation-positive, Non-small Cell Lung Cancer(TORG1425)
Date of disclosure of the study information 2014/12/15
Last modified on 2020/05/15 (Ver. 11)

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Basic information
Public title A Prospective, Multi-center Phase II Trial on the Efficacy and Safety of Low-dose Erlotinib Monotherapy for Frail Patients with EGFR Mutation-positive, Non-small Cell Lung Cancer(TORG1425)
Acronym Low-dose Erlotinib for Frail Patients with EGFR Mutation-positive Non-Small Cell Lung Cancer(TORG1425)
Scientific Title A Prospective, Multi-center Phase II Trial on the Efficacy and Safety of Low-dose Erlotinib Monotherapy for Frail Patients with EGFR Mutation-positive, Non-small Cell Lung Cancer(TORG1425)
Scientific Title:Acronym Low-dose Erlotinib for Frail Patients with EGFR Mutation-positive Non-Small Cell Lung Cancer(TORG1425)
Region
Japan

Condition
Condition Non-small Cell Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy and safety of low dose erlotinib for frail patients with advanced or recurrent non-small cell lung cancer with EGFR mutation who are concerned about increase toxicities by standard chemotherapy.
Basic objectives2 Others
Basic objectives -Others Safety, Efficacy
PK, PD
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response Rate
Key secondary outcomes -Disease Control Rate
-Response Rate containing SD patients after dose escalation
-Safety
-Progression Free Survival
-Overall Survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Erlotinib treatment
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) patients with pathologically or proven non-small cell lung cancer
2) patients having EGFR mutation (exon 19 or Exon 21)
3) patients with stage IIIB or IV who are not candidates for curative radiotherapy
4) patients without prior chemotherapy for lung cancer and who satisfies either of the followings;
i) aged > 80 years old
ii) aged 75 - 80 years old and > 6 points Charlson comorbidity index or > P. S. 1
iii) aged 20-74 years old and > 6 points Charlson comorbidity index or > P. S. 2
5) patients who have measurable lesions by RECIST v.1.1
6) adequate laboratory findings as below(within 2 weeks prior registration);
- neutrophil > 1,000/mm3
- hemoglobin > 8.0g/dl
- platelet > 75,000/mm3
- total bilirubin: within 3 times of upper normal limit
- AST, ALT: within 5 times of upper normal limit
- SpO2 > 90%(oxygen dosage or not)
7) signed informed consent
8) life expectance more than 4 weeks
Key exclusion criteria 1) prior EGFR-TKI
2) active concomitant malignancy
3) concomitant brain metastasis require radiotherapy
4) interstitial pneumonia or lung fibrosis evident on CT
5) symptomatic ophthalmologic disease
6) patients having clinically important ophthalmic disorder
7) patients having clinically important neuropsychiatric disorder
8) pregnant or lactating women or those who declined contraception
9) patients judged to be not suitable by the attending physician
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Yamada
Organization Kurume University School of Medicine
Division name Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine
Zip code
Address 67 Asahi-machi, Kurume, Fukuoka
TEL 0942-31-7560
Email kayamada@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Miyamoto
Organization Japanese Red Cross Medical Center
Division name Division of Chemotherapy Department of Internal Medicine
Zip code
Address 4-1-22 Hiroo, Shibuya-ku, Tokyo
TEL 03-3400-1311
Homepage URL
Email torg1425@med.jrc.or.jp

Sponsor
Institute NPO Thoracic Oncology Research Group
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 12 Month 15 Day

Related information
URL releasing protocol -
Publication of results Published

Result
URL related to results and publications https://jamanetwork.com/journals/jamaoncology/article-abstract/2765756
Number of participants that the trial has enrolled 80
Results 
An independent review committee confirmed a significant ORR of 60.0%(90% CI, 50.2%-69.2%). The disease control rate was 90.0%(90% CI, 82.7%-94.9%), median progression-free survival was 9.3 months (95%CI, 7.2-11.4 months), and median overall survival was 26.2 months (95%CI, 21.9-30.4 months).
Results date posted
2020 Year 05 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 05 Month 14 Day
Baseline Characteristics 
Eighty patients were enrolled, with a median (range) age of 80 (49-90) years; 54 (68%) were men.
Participant flow 
-
Adverse events 
Mild adverse events were observed in some participants, with few patients exhibiting grade 3 or greater adverse events. Low-dose erlotinib treatment was temporarily suspended for 10 patients owing to adverse events. Five of 80 patients (6%) had their erlotinib dose reduced to 25mg because of oral mucositis, paronychia, erythema multiforme, diarrhea, and anorexia.Two patients discontinued treatment because of adverse events (cutaneous ulcer and bone
infection, and oral mucositis, respectively).
Outcome measures 
-
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 10 Month 04 Day
Date of IRB
2014 Year 12 Month 16 Day
Anticipated trial start date
2015 Year 01 Month 07 Day
Last follow-up date
2018 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 12 Month 15 Day
Last modified on
2020 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018280