Advanced or Metastatic Non-small Cell Lung Cancer
Conditions
Brief summary
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with Adebrelimab with or without other Antitumor Therapy in Advanced or Metastatic Non-small cell lung Cancer. To explore the reasonable dosage of SHR-A2102 for Advanced or Metastatic Non-small cell lung Cancer
Interventions
Drug: SHR-A2102 for injection.
Adebrelimab injection.
DRUGCisplatin injection
Cisplatin injection.
DRUGCarboplatin injection
Carboplatin injection.
DRUGBevacizumab Injection
Bevacizumab injection.
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements. 2. The age of signing the informed consent is 18 -70 years, regardless of gender. 3. Provide archived or fresh tumor tissue for vendor test. 4. At least one measurable lesion according to RECIST v1.1 criteria. 5. Patients with locally advanced or metastatic non-small cell lung cancer who have been confirmed by histological or cytological examination to be inoperable and unable to undergo radical radiotherapy or chemotherapy. 6. The ECOG score is 0 or 1. 7. Expected survival ≥12 weeks. 8. Good level of organ function. 9. Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods.
Exclusion criteria
1. Active or symptomatic brain metastases. 2. With the exception of patients diagnosed with any other malignancy, except those who have achieved complete remission at least 5 years prior to screening and have ended adjuvant therapy, can be treated locally and have a clear medical record of cure, such as basal cell or squamous cell carcinoma of the skin, superficial bladder cancer in situ, carcinoma in situ of the cervix, breast ductal carcinoma in situ, and papillary carcinoma of the thyroid. 3. Uncontrollable moderate to large amounts of pleural effusion, peritoneal effusion or pericardial effusion. 4. Patients with uncontrolled tumor-related pain . 5. Have antitumor therapy was received 4 weeks before the start of the study. 6. Perform non-chest radiation therapy with \>30 Gy within 28 days before dosing, chest radiation therapy with \>30 Gy within 24 weeks before first dosing, and radiation therapy with ≤30 Gy within 14 days before first dosing. 7. Subjects who are participating in another clinical study or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or the 5 half-life of the investigational drug, whichever is longer. 8. Surgical procedures requiring tracheal intubation and general anesthesia were performed within 28 days prior to the initial study, diagnostic or superficial surgery was performed within 7 days prior to the initial study, or elective surgery was expected during the trial period. 9. Toxicity and/or complications of previous antitumor therapy did not return to NCI-CTCAE level ≤1 or
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RP2D | through phase IB completion, an average of 1 years | RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in Phase IB stages； |
| Incidence and severity of AE(DLT) | from Day1 to 90 days after last dose | According to NCI-CTCAE v5.0 evaluation criteria from Day 1 to 90 days after last dose； |
| ORR | 18 months after the last subject was enrolled in the group | efficacy was assessed every 6 weeks within 48 weeks and every 9 weeks after 48 weeks s as determined by RECIST1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DCR | 18 months after the last subject was enrolled in the group | Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1； |
| OS(Investigator evaluation) | 18 months after the last subject was enrolled in the group | Since C1D1 and death from any cause； |
| DOR | 18 months after the last subject was enrolled in the group | Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1； |
| PFS(Investigator evaluation) | 18 months after the last subject was enrolled in the group | Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1； |
Countries
China
Contacts
Primary ContactYunfei Zhang
Outcome results
None listed