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

JRCT ID: jRCT2061230111

Registered date:15/03/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Carcinoma, Non-Small-Cell Lung
• Date of first enrollment: 01/04/2024
• Target sample size: 148
• Study type: Interventional

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

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

• Primary Sponsor: Iizuka Kenzo