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

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

Iizuka Kenzo

Delta-Fly Pharma, Inc.

3-11-5, Nihonbashi-honcho, Chuo-ku, Tokyo

dfp_drugsafety@delta-flypharma.co.jp

Iizuka Kenzo

Delta-Fly Pharma, Inc.

3-11-5, Nihonbashi-honcho, Chuo-ku, Tokyo

+81-3-6231-1278

dfp_drugsafety@delta-flypharma.co.jp

Recruiting

April. 01, 2024

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- 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.

- 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.

Both

Carcinoma, Non-Small-Cell Lung

Study arm: DFP-14323 10 mg and afatinib 20 mg orally once daily.
Control arm: Afatinib 40 mg orally once daily.

PFS per BICR, according to RECIST ver.1.1 [Time Frame: Up to 54 months]

PFS, 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

No

none