Non-small Cell Lung Cancer
Conditions
Brief summary
This trial is a single arm, two cohorts, phase II study. All patients are stage IIIB-IV NSCLC, Eastern Cooperative Oncology Group (ECOG) performance status 0-1 and no sensitizing mutation of the epidermal growth factor receptor gene or translocation of the anaplastic lymphoma kinase gene. Cohort 1 includes patients with metastatic or recurrent NSCLC after progression on treatment with platinum-based chemotherapy and PD-1/PD-L1, given concurrently or sequentially. Cohort 2 includes treatment naïve patients with advanced NSCLC. All patients will recieve AK104 15mg/kg every 3 weeks(for up to 2 years) and anlotinib(12mg/d). The primary end point are objective response rate per RECIST1.1 and safety. Secondary end points are progression-free survival and overall survival.
Interventions
DRUGAK104+anlotinib
AK 104 is given by intravenous infusion and anlotinib is given by oral.
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18 to 75 years old (at the time consent is obtained); * Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures); * Have histologically- or cytologically-confirmed diagnosis of StageIIIB/C or IV NSCLC; * Additional Inclusion Criteria for Cohort 1: Has metastatic or recurrent NSCLC after progression on treatment with platinum-based chemotherapy and PD-1/PD-L1, given concurrently or sequentially; * Additional
Exclusion criteria
for Cohort 2: Have no prior systemic chemotherapy for metastatic disease: at least 6 months since prior adjuvant chemotherapy; * EGFR/ALK negative; * Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy; * Have a life expectancy of at least 3 months; * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; * Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the site study team; * Has adequate organ function as defined by: (1) Absolute neutrophil count \>= 1,500/uL; (2) Platelets \>= 100,000/uL; (3) Hemoglobin \>= 9 g/dL; (4) Crcl \>= 50ml/min; creatinine clearance may be calculated using the institutional/laboratory standard method; (5) Serum total bilirubin \<= 1.5 ULN; (6) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<= 2.5 ULN; (7) Albumin \>= 28g/L; (8) International Normalized Ratio (INR) and aPTT \<1.5 ULN; (9) Left ventricular ejection fraction \>= 50%; * Have recovered from the effects of any prior radiotherapy or surgery; * All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | through study completion, an average of 1 year | objective response rate per RECIST1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS and OS | through study completion, an average of 2 years | progression-free survival and overall survival |
Contacts
Primary Contactweiwei Shi
Outcome results
None listed