Carcinoma, Non-Small-Cell Lung
Conditions
Interventions
Study arm: DFP-14323 10 mg and afatinib 20 mg orally once daily.
Control arm: Afatinib 40 mg orally once daily.
Sponsors
Iizuka Kenzo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS per BICR, according to RECIST ver.1.1 [Time Frame: Up to 54 months] | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactKenzo Iizuka
Delta-Fly Pharma, Inc.
Outcome results
None listed