Resectable Non-small Cell Lung Cancer
Conditions
Brief summary
AK112, alone or in combination with chemotherapy for the neoadjuvant/adjuvant treatment of resectable NSCLC
Detailed description
Phase II clinical study of AK112, an anti-PD-1 and VEGF bispecific antibody, alone or in combination with chemotherapy for the neoadjuvant/adjuvant treatment of resectable non-small cell lung cancer
Interventions
DRUGAK112
IV infusion
DRUGCarboplatin
IV infusion
DRUGCisplatin
IV infusion
DRUGPaclitaxel
IV infusion
Sponsors
Akeso
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 18 to 75 years old 2. Be able and willing to provide written informed consent and to comply with all requirements of study participation 3. Histologically confirmed resectable stage II-IIIB NSCLC 4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5. Has adequate organ function 6. 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.
Exclusion criteria
1. Is currently participating in a study of an investigational agent or using an investigational device 2. Has an active autoimmune disease that has required systemic treatment in the past 2 years 3. Has an active infection requiring systemic therapy 4. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected) 5. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study 6. Has received a live virus vaccine within 30 days prior to first dose of study treatment 7. Is pregnant, breastfeeding, or expecting to conceive or father a child within the projected duration of the study including 120 days following the last dose of study treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events (AE) | Up to approximately 2 years | Summary of AE incidence; summary after grading of AE according to NCI CTCAE version 5.0 |
| Rate of surgical delays | Up to approximately 2 years | Proportion of subjects exceeding the maximum surgical time window |
| Abnormal laboratory findings of clinical significance | Up to approximately 2 years | Proportion of subjects with abnormal and clinically significant results including routine blood tests, blood biochemical tests, coagulation tests, thyroid function tests, routine urine tests, pregnancy tests, etc. |
| Major pathological response (MPR) | Up to approximately 2 years | Proportion of subjects with ≤10% residual live tumor cells in resected primary tumor and lymph nodes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| R0 resection rate | Up to approximately 2 years | Proportion of subjects with pathologically complete resection of primary tumors |
| Tumor descending stage rate | Up to approximately 2 years | Proportion of subjects with the most recent tumor staging prior to surgery (using TNM staging version 8) who were down-staged relative to baseline |
| Pathological complete response (pCR) | Up to approximately 2 years | Proportion of subjects with no residual tumor in the resected primary tumor and lymph nodes |
| Overall survival (OS) | Up to approximately 2 years | Time from first dose until death from any cause |
| Event free survival (EFS) | Up to approximately 2 years | Time from first dose to the occurrence of any of the following events, whichever occurs first: disease progression, local recurrence or distant metastasis or death from any cause, as assessed according to RECIST v1.1. |
| Objective response rate (ORR) | Up to approximately 2 years | ORR is the proportion of subjects with CR or PR, based on RECIST v1.1. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORChangli Wang
Tianjin Medical University Cancer Institute and Hospital
Outcome results
None listed