azertinib for NSCLC harboring activating EGFR mutations in TKI naïve patients: A single-arm, phase II single-center trial

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

1.Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer which is not amenable to treatment with a curative aim (e.g. surgery or radiation). Patients who underwent curative intent surgery or definitive CRT and experience recurrence after 6 months are eligible.
2.Stage IIIC or IV by AJCC 8th edition
3.Confirmed EGFR mutations (exon 19 deletion, L858R)
(The result from both cell-free DNA or tissue-based DNA from the local test is allowed.)
4.Age of 19 or more.
5.Performance status of Eastern Cooperative Oncology Group 0 to 2.
6.Expected minimum life expectancy of 12 weeks
7.Adequate organ function.
• ANC =1500cells/mm3
• PLT =100,000cells/mm3
• Totlal bilirubin =1.5 x (ULN)
• AST/ALT = 2.5 x ULN ( =5.0 x ULN)
• Creatinine =1.5 x (ULN) CCr = 45mL/min (Cockcroft– Gault)
8.Available to provide the adequate tissue and blood for the genomic tests
- At least 15 unstained slide and 20 cc of blood at baseline (mandatory) and disease progression.
9.Agreed to perform re-biopsy at the timepoint of disease progression.
10. At least two weeks after the chemotherapy
11.Female subjects must either be of non-reproductive potential
12.Subject willing and able to comply with the protocol
13.Signed written informed consent

Exclusion Criteria

1.Previously treatment with any kind of EGFR TKI (Previously chemotherapy treated patients is allowed)
2.Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug. (allowed for participation if investigator decided that previous malignancy is cured and not need for any additional treatment)
3.Uncontrolled central nervous system metastases
- patient with asymptomatic brain metastases or CNS symptom manageable with TKI and evaluated by investigator can be enrolled.
4.Spinal cord compression, leptomeningeal carcinomatosis
5.Uncontrolled systemic illness, including uncontrolled hypertension, active bleeding, or active infection
6.Radiotherapy with a wide field of radiation within 2 weeks or radiotherapy with a limited field of radiation (localized radiotherapy or gamma knife surgery) for palliation within 1 week
7.Any unresolved toxicities from prior therapy, greater than CTCAE grade 1
8.Mean QT interval corrected for heart rate (QTc) = 470 ms
9.No measurable lesion
10.Unable to swallow the product due to refractory nausea, vomiting or chronic gastrointestinal disease.

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
progression-free survival;Resistance mechanism analysis

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR);Duration of Response (DoR);Disease control rate (DCR);Overall survival (OS);intracranial PFS (iPFS);intracranial ORR (iORR;intracranial DCR (iDCR)