YAMATO study

JRCT ID: jRCTs031200021

Registered date:22/04/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: lung cancer
• Date of first enrollment: 07/05/2020
• Target sample size: 110
• Study type: Interventional
• Intervention(s): Continue to take afatinib once a day at 30 mg or 40 mg for 8 months. If progression of the primary disease is not observed, switch to osimertinib once a day at 80 mg.

Outcome(s)

• Primary Outcome: 2-year progression-free survival

Secondary Outcome

Objective response rate: ORR
Time to treatment failure: TTF
Overall survival: OS
Progression-free survival: PFS
Adverse event rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

All of the following conditions must be satisfied.
1. Patients with non-squamous NSCLC pathologically confirmed
2. Non-curable clinical stage IIIB, IIIC, IV, or postoperative recurrence
3. Patients with EGFR gene mutation positive (Exon19 deletion mutation (Exon19del) or Exon21 point mutation (L858R))
4. The patient has been fully informed of the disease name and condition by the doctor in advance
5. Patients who have not received anticancer treatment with cytotoxic anticancer drugs, molecular targeted drugs, and immune checkpoint inhibitors
6. The age at the time of obtaining consent is over 20 years old
7. ECOG Performance status (PS) is 0-1
8. Main organ functions are maintained
9. QTc: <= 480 msec
10. Having a measurable lesion or an evaluable unmeasurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) ver 1.1
11. Expected to survive for more than 3 months
12. Patients have given written informed consent after the study has been fully explained prior to enrollment

Exclude criteria

1. Patients with a history of drug-induced lung injury or patients with interstitial pneumonia that is evident on chest CT
2. Patients with symptomatic brain metastases.
3. Patients with meningeal carcinomatosis
4. Patients with spinal metastases that require radiation therapy or surgery
5. Patients with pleural effusion, ascites or pericardial effusion that require drainage
6. Patients who received radiation therapy including lungs within 14 days prior to registration (including palliative radiation therapy)
7. Patients with active multiple primary cancer
8. Patients with local or systemic active infections that require treatment
9. Pregnant, breastfeeding, women who may be currently pregnant, or patients who are not willing to contraceptive
10. Patients judged to be difficult to enroll in this study due to clinically problematic psychiatric / neurological disorders
11. Patients receiving continuous systemic administration of steroids (low-dose steroids (up to 10 mg prednin equivalent) or immunosuppressants)
12. Patients with a history of severe hypersensitivity
13. Patients with clinical complications (such as poorly controlled heart, lung, liver, kidney disease, diabetes, etc.)
14. Other patients who are judged inappropriate by the doctor in charge
* 1 Active double cancer is synchronous double cancer and metachronous double cancer with a disease-free period of 5 years or less, equivalent to carcinoma in situ (carcinoma in situ) or carcinoma in mucosa, which is judged to be cured by local treatment Lesions should not be included in active double cancer
* 2 Handling of hepatitis virus infection is as follows.
1)HBc antibody and / or HBs antibody positive and less than HBV-DNA 1.3 Log IU / mL (20 IU / mLl): qualified. However, litigation treatment should be performed with careful monitoring of HBV-DNA.
2) HBV antibody and / or HBs antibody positive and HBV-DNA 1.3 Log IU / mL (20 IU / mL1) or more: Eligible for cases where nucleic acid analog prophylaxis is being administered appropriately. In that case, litigation treatment should be performed with careful monitoring of HBV-DNA.
3) HBsAg positive: Not qualified

Related Information

• Primary Sponsor: Yoshioka Hiroshige
• Secondary Sponsor: Thoracic oncology Research Group