Hypothesis generative H2H study comparing the efficacy between afatinib and osimertinib based on the immunological biomarker in the NSCLC patients with EGFR mutations

JRCT ID: jRCTs031190221

Registered date:25/02/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: EGFR-mutant non-small cell lung carcinoma with recurrent/advanced stage
• Date of first enrollment: 12/05/2020
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Group A: Afatinib 40mg/day
Group B: Osimertinib 80mg/day

Group A: T790M positive by re-biopsy, the next treatment drug must be osimertinib 80mg/day

Outcome(s)

Primary Outcome

Survival rate at 3 years
Exploratory analysis of immunological biomarker

Secondary Outcome

Progression-free survival 1
Progression-free survival 2
Overall survival
Time to discontinuation of treatment or death1
Time to discontinuation of treatment or death2
Time to first subsequent therapy or death
Objective response rate

Key inclusion & exclusion criteria

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

Include criteria

1) Histologically or cytologically confirmed non-small, non-squamous cell lung carcinoma.
2) Stage IIIB, IIIC or IV non-squamous, non-small cell lung cancer including post operation recurrence.
3) Harboring sensitizing EGFR mutations with histological or cytological specimen except for de novo T790M.
4) Measurable disease, as defined by RECIST ver 1.1.
5) No prior cytotoxic chemotherapy or immunotherapy and appropriate for administration of 1st line afatinib or osimertinib.
6) 20 years or older.
7) ECOG PS 0 or 1.
8) Adequate hematologic and end organ function.
9) Predicted at least 3 months prognosis.
10) Permitted re-biopsy before 2nd line treatment by any procedure.
11) Written informed consent form.

Exclude criteria

1) History of interstitial lung disease or radiation pneumonitis.
2) Malignancies other than NSCLC within 2 years.
3) Adjuvant chemotherapy within a year.
4) Uncontrolled infectious disease.
5) Women who are pregnant, lactating, or intending to become pregnant during the study
6) Uncontrolled heart, lung, liver, renal diseases.
7) Other reasons.

Related Information

• Primary Sponsor: Seki Nobuhiko
• Source(s) of Monetary Support: Boehringer Ingelheim Japan, Inc.