NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2061230111

Registered date:15/03/2024

Phase III Study of DFP-14323 plus Afatinib in Patients with NSCLC Harboring Uncommon EGFR mutations

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedCarcinoma, Non-Small-Cell Lung
Date of first enrollment03/07/2024
Target sample size148
Countries of recruitment
Study typeInterventional
Intervention(s)Study arm: DFP-14323 10 mg and afatinib 20 mg orally once daily. Control arm: Afatinib 40 mg orally once daily.

Outcome(s)

Primary OutcomePFS per BICR, according to RECIST ver.1.1 [Time Frame: Up to 54 months]
Secondary OutcomePFS, DCR, ORR, DOR, OS, type and severity of adverse events and side effects (CTCAE ver. 5.0), time to drug withdrawal to consider dose reduction, post-treatment

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria- Patients with histologically or cytologically confirmed diagnosis of lung adenocarcinoma. - Patients with stage III/IV inoperable, inoperable by radical radiotherapy, or recurrent after surgery/chemoradiotherapy. - Patients with Uncommon EGFR mutation by genetic testing. - Patients with disease evaluable by RECIST ver. 1.1 within 4 weeks prior to enrollment. - Patients without prior treatment with chemotherapy, including treatment for other cancer types. - Patients with Performance Status (ECOG scale): 0 to 1.
Exclude criteria- Patients with T790M or Exon20 insertion mutation positive. - Patients with a clinical history of interstitial pneumonia or clinical signs of interstitial pneumonia. - Patients with active multiple cancers. - Patients with symptomatic brain metastases. - Patients receiving continuous systemic steroid treatment.

Related Information

Contact

Public contact
Name Kenzo Iizuka
Address 3-11-5, Nihonbashi-honcho, Chuo-ku, Tokyo Tokyo Japan 103-0023
Telephone +81-3-6231-1278
E-mail dfp_drugsafety@delta-flypharma.co.jp
Affiliation Delta-Fly Pharma, Inc.
Scientific contact
Name Kenzo Iizuka
Address 3-11-5, Nihonbashi-honcho, Chuo-ku, Tokyo Tokyo Japan 103-0023
Telephone +81-3-6231-1278
E-mail dfp_drugsafety@delta-flypharma.co.jp
Affiliation Delta-Fly Pharma, Inc.