The Clinical Trial of BIBW2992 for patients with solid tumors harboring NRG1 fusion

JRCT ID: jRCT2041220036

Registered date:01/07/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with solid cancer harboring NRG1 fusion gene
• Date of first enrollment: 01/07/2022
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Afatinib is orally administered at a dose of 40 mg once daily on an empty stomach. In principle, 4 weeks (28 days) will be regarded as 1 cycle. Depending on the condition of patients, the treatment should be discontinued, suspended, or restarted, or the dose should be reduced. The dose of afatinib may be increased to 50 mg once daily at the start of Cycle 2 or later if all of the following criteria are met in Cycle 1.

Outcome(s)

• Primary Outcome: Response rate (RR)

Secondary Outcome

1. Progression free survival (PFS)
2. Overall survival (OS)
3. Duration of Response (DOR) and duration of CR
4. Disease Control Rate (DCR)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients with advanced solid cancer which has been pathologically diagnosed by the time of consent, have NRG1 fusion gene with preserved EGF-like domain and in refractory or intoletance to standard treatment
2. Patients with a lesion measurable
3. Patients with performance status of 0 to 1 at the time of consent
4. Patients expected to survive for 12 weeks or longer from the initiation day of the treatment
5. Patients whose major organ functions meet the criteria within 28 days before the initiation of administration
6. Patients aged 18 years or more at the time of consent
7. Patients who voluntarily gave written consent after receiving sufficient explanation regarding this clinical trial

Exclude criteria

1. Patients who received the last administration of anticancer drugs (chemotherapy, immunotherapy, biotherapy, etc.) within 21 days before enrollment
2. Patients who have participated in another clinical trial within 21 days before enrollment and within 21 days from last administration of investigational drug on that trial (except for acceptable national trials on authorized indication of disease, dosegae and administration for that investigational drug)
3. Patients with haboring common EGFR mutation (Exon 19 deletion or L858R point mutation)
4. Patients who have history of previous chemotherapy targeting to HER2/HER3
5. Patients whose toxicity due to the previous treatment has not been alleviated to Grade 1 or less severe conditions when assessed according to NCI CTCAE ver. 5.0 (However, patients with Grade 2 or less severe toxicity in stable condition are eligible.)
6. Patients with symptomatic metastasis to the central nervous system (patients with metastasis can be enrolled; if metastasis is asymptomatic, on treatement or local therapy was completed without requirement of increasing dosage of corticosteroid and neurologically stable at leaset 1 week before enrollement)
7. Patients with double cancer with disease-free period less than 1 year (excluding gastrointestinal cancer completely resected by endoscopic mucosal resection, completely resected carcinoma in situ of the cervix, localized or expectively curable prostate cancer, completely resected basal/squamous cell carcinoma of the skin, and other solid tumors similarly expected cure with curable treatment to disease in early disease stage)
8. Patients with active infection requiring systemic administration of antibiotics, antifungal drugs, antiviral drugs, etc.
9. HBs antigen-positive patients
10. Patients complicated with or with a history of interstitial lung disease obvious on images (interstitial pneumonia, pneumonitis, pulmonary fibrosis, etc.)
11. Patients with pleural effusion, pericardial effusion, or ascites that requires drainage (patients with pleural effusion, pericardial effusion, or ascites that has been drained at least 1 week before the enrollment and has not required re-drainage are acceptable)
12. Patients with a clinical symptom or a finding of intestinal obstruction requiring drip infusion or central venous nutrition
13. Patients with a history of serious hypersensitivity or anaphylactic reaction to the components of the investigational product
14. Patients with a serious complication (liver disease [Child Pugh C], renal disease [Ccr is less than 30 mL/min], heart disease, lung disease, blood disease, brain disease, etc.)
15. Female patients who are breast-feeding (excluding those who agree to discontinue breast-feeding during the trial period and for 2 weeks after the last administration of the investigational product)
16. Female patients who are pregnant or tested positive in pregnancy test
17. Male patients or female patients of childbearing potential who are unwilling to use adequate contraception methods during the trial and for 2 weeks after the last administration of the investigational product
18. Other patients who are judged by the investigator or subinvestigator to be inappropriate for participation in this trial

Related Information

• Primary Sponsor: Ando Yuichi
• Source(s) of Monetary Support: Boehringer-Ingelheim Pharma GmbH & Co. KG