Advanced Non-small Cell Lung Cancer
Conditions
Brief summary
This is a Phase II clinical study conducted in China to evaluate the treatment of advanced non-small cell lung cancer with JSKN016. The enrolled subjects are all in the locally advanced or metastatic stage of non-small cell lung cancer.The study is divided into two parts. The main objective of part I is to assess the efficacy and safety of JSKN016 in selected subjects with advanced non-small cell lung cancer. The main objective of part II is to compare the efficacy of JSKN016 and docetaxel in subjects with advanced non-small cell lung cancer.
Detailed description
This is a Phase II clinical study conducted in China to evaluate the treatment of advanced non-small cell lung cancer with JSKN016. The enrolled subjects are all in the locally advanced or metastatic stage of non-small cell lung cancer.The study is divided into two parts. The main objective of part I is to assess the efficacy and safety of JSKN016 in selected subjects with advanced non-small cell lung cancer. The main objective of part II is to compare the efficacy of JSKN016 and docetaxel in subjects with advanced non-small cell lung cancer.
Interventions
DRUGJSKN016
Administered intravenously according to protocol.
DRUGDocetaxel
Administered intravenously according to protocol.
Sponsors
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Voluntarily participate and sign the informed consent form. 2. Age ≥ 18 years old, male or female. 3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1. 4. Expected survival ≥ 3 months. 5. Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not suitable for radical surgery and/or radical radiotherapy, and meets one of the following conditions: EGFR sensitive mutations, and failed treatment with EGFR-TKI; Driver gene negative, treated with PD-1/L1 inhibitors and a platinum-containing chemotherapy and treatment failure; Positive driver gene, failure of corresponding standard therapy; 6. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria. 7. Recently archived or fresh tumor tissue samples are available. 8. Have good organ function. 9. Have no current birth plans and agree to contraception during the trial.
Exclusion criteria
1. Presence of any small cell carcinoma component in histopathology. 2. Subjects with other malignant tumors within 5 years prior to enrollment, and other tumors have been cured through local therapy, such as cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-primary invasive bladder cancer, and prostate/cervical/breast cancer in situ. 3. Presence of brainstem, meningeal metastases, spinal cord metastases or compression, leptomeningeal metastases, or history of carcinomatous meningitis; Presence of active brain metastases. 4. During the screening period, imaging shows that the tumor invades, compresses, or occurs in the surrounding important organs (such as the heart and pericardium, trachea, esophagus, superior vena cava, etc.) or there is a risk of esophageal tracheal fistula or esophageal pleural fistula. 5. Adequate washout of previous therapy before the first dose. 6. Gastrointestinal abnormalities with obvious clinical manifestations. 7. Presence of clinically severe respiratory impairment caused by pulmonary disease complications. 8. Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors. 9. Prior treatment with topoisomerase I inhibitors (e.g., irinotecan, topotecan), antibody-drug conjugates containing topoisomerase I inhibitors (e.g., DS-8201, HER3-DXd, DS-1062), or targeting TROP2 or HER3. 10. Previous treatment with docetaxel. 11. Have an uncontrolled infection, a history of immunodeficiency, a positive human immunodeficiency virus (HIV) test, or a history of AIDS. 12. Previous history of allogeneic bone marrow or organ transplantation. 13. Known allergy to any component of the study drug, and previous history of severe allergic reaction to other antibody drugs. 14. Pregnant and/or lactating females. 15. Have local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which can lead to higher medical risk and/or uncertainty in survival evaluation, such as tumor leukemia response , cachexia manifestations, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR assessed by the investigator per RECIST v1.1 | Up to 24months | Objective response rate (ORR) was defined as the proportion of participants who achieve either complete response \[CR\] or partial response \[PR\] per Response Evaluation Criteria in Solid Tumors (RECIST v1.1） |
| Safety reflected by AE | Up to 24months | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TTR assessed by the investigator per RECIST v1.1 | Up to 24months | Time to response (TTR) is defined as the time to response base on RECIST v1.1. |
| PFS assessed by investigator per RECIST v1.1 | Up to 24months | Progression-free survival (PFS) is defined as the time from the date of initial administration till the first documentation of disease progression assessed by the investigator or death due to any cause (whichever occurs first). |
| OS | Up to 24months | Overall Survival (OS) is defined as the time from the date of initial administration till death due to any cause. |
| DOR assessed by the investigator per RECIST v1.1 | Up to 24months | Duration of response (DoR) assessed according to RECIST v1.1. |
| AUC of JSKN016 | Up to 24months | The blood PK parameters of JSKN016 and its analytes for area under the concentration-versus-time curve from time 0 to the last quantifiable concentration as calculated by the linear-up log-down trapezoidal method (AUClast) and AUC from time 0 to infinity (AUCinf) elimination rate constant associated with the terminal phase were estimated using standard non-compartmental methods. |
| Tmax of JSKN016 | Up to 24months | Time of Maximum blood Concentration (Tmax) of JSKN016 Following First Dose |
| ADA | Up to 24months | Number of subjects with detectable anti-drug antibodies (ADA). |
| Cmax of JSKN016 | Up to 24months | Maximum (Peak) Observed blood Concentration (Cmax) of JSKN016 Following First Dose |
| DCR assessed by the investigator per RECIST v1.1 | Up to 24months | Disease control rate (DCR) assessed according to RECIST v1.1. |
Contacts
Primary ContactLi Zhang
Outcome results
None listed