The oral administration of amino acids cystine and theanine for patients with advanced EGFR mutation-positive non-small-cell lung cancer

The oral administration of amino acids cystine and theanine for patients with advanced EGFR mutation-positive non-small-cell lung cancer - Trial of amino acids cystine and theanine

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020781

Enrollment

Registered

2016-01-29

Start date

2016-02-01

Completion date

Unknown

Last updated

2026-06-29

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

Interventions

afatinib 40mg cystine 700mg theanine 280mg oral onece a day, 30days afatinib 40mg placebo oral onece a day, 30days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed recurrence or advanced NSCLC. (stage III or IV) 2) Afatinib have not been carried out for lung cancer. 3) Histologically confirmed EGFR mutation-positive. 4) Patient planing to receive afatinib for lung cancer. 5) 20<= years old 6) Performance Status (ECOG) 0-2 7) The functions of the main organs are maintained. 8) Patients who have estimated life expectancy longer than 90 days. 9) Submission of written informed consent concerning study participation.

Exclusion criteria

Exclusion criteria: 1) Enable to oral administration 2) Ileus or intestinal obstruction 3) Constitutional diarrhea 4) Unrecovered Grade 1<= diarrhea or oral mucositis cause of previous treatment 5) Severe interstitial pneumonia 6) Uncontrollable pleural or cardiac effusion 7) Other serious complications 8) Severe allergy history 9) Receiving continuous systemic corticosteroid 10) Psychological disorder difficult to participate in this study 11) Women who are currently pregnant or will not be compliant with a medically approved contraceptive regimen during treatment period. Men who will not be compliant with a contraceptive regimen during treatment period. 12) With phenylketonuria 13) Others judged by the investigator to be unsuitable for the study

Design outcomes

Primary

Measure	Time frame
Adverse events	—

Secondary

Measure	Time frame
serum glutathione	—

Countries

Japan

Contacts

Public ContactMadoka Kimura

Osaka International Cancer Institute Department of Thoracic Oncology

kimura-ma2@mc.pref.osaka.jp81-6-6945-1181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026