Status:
RECRUITING
First-line Treatment With Dacomitinib Plus Anlotinib for Patients With Advanced NSCLC With EGFR 21L858R Mutations
Lead Sponsor:
Shanghai Chest Hospital
Conditions:
Non-Small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a multicenter, open label, Phase I/IIB study investigating the efficacy and safety of treatment with dacomitinib plus anlotinib as first-line therapy for patients with advanced non-small cell ...
Eligibility Criteria
Inclusion
- ≥18 years of age and ≤75 years;
- Provision of a voluntarily given, personally signed and dated, written informed consent document;
- Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic stage IIIB or IV non-small cell lung cancer (NSCLC);
- It is acceptable for subjects with the presence of EGFR activating mutation (exon 19 deletion and the L858R mutation in exon 21) to be included in this Phase I study; Only subjects with the L858R mutation in exon 21 to be included in this Phase IIb;
- At least one measurable disease by RECIST criteria version 1.1;
- Patients with controlled or stable brain metastases;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1, and life expectancy of at least 3 months;
- No prior treatment with systemic therapy for advanced NSCLC, including TCM treatments;
- Able to comply with required protocol procedures and able to receive oral medications;
- Adequate organ function, including:
- (1) Adequate bone marrow function Hemoglobin≥90g/L, absolute neutrophil count (ANC) should be ≥ 1.5x109/L, platelets should be ≥ 80x109/L; (2) Adequate liver function Total bilirubin ≤ 1.5 x upper normal limit (ULN), Aspartate Aminotransferase (AST) (SGOT) ≤ 2.5 x ULN (≤ 5.0 x ULN if hepatic metastases), Alanine Aminotransferase (ALT) (SGPT) ≤ 2.5 x ULN (≤ 5.0 x ULN if hepatic metastases), Creatinine≤ 1.5 x upper normal limit (ULN), or ≥ 60 mL/min; (3) Cardiac function: LVEF≥50% assessed by Doppler ultrasound；
Exclusion
- Small cell lung cancer (including mixed small cell and non-small cell lung cancer) and squamous cell carcinoma with cavitation;
- Patients with concurrent EGFR T790M mutation or unknown mutation status or other mutation types;
- Diagnosis of any other malignancy during the last 5 years, or with other malignancies at present;
- Patients with pre-existing meningeal metastases;
- Patients who have concurrent other malignant tumors;
- Any history of hemoptysis, hematochezia, bloody sputum;
- Tumor invasion or adjacent major vessels;
- Patients with uncontrolled or significant systematic disease, including: active infection, thyroid dysfunction, uncontrolled hypertension, unstable angina pectoris, congestive heart failure, or myocardial infarction within 6 months, or severe arrhythmia requiring medication;
- A history of other diseases, or metabolic dysfunction, or physical examination or laboratory results suggestive of a disease or condition that precludes the use of an investigational drug, or may affect the interpretation of the study results, or expose the patient to a high risk of treatment complications;
- Any astrointestinal disorders resulting in inability to take medications orally, or requiring intravenous (IV) nutrition, or previous surgery impair drug absorption;
- Pregnant or lactating females;
- Patients allergic to any pharmaceutical ingredient.
Key Trial Info
Start Date :
October 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT05271916
Start Date
October 13 2022
End Date
May 1 2027
Last Update
April 19 2023
Active Locations (1)
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1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200000