Non-small Cell Lung Cancer
Conditions
Brief summary
Fluzoparib combined with Camrelizumab for maintenance treatment of locally advanced non-small cell lung cancer after concurrent radiotherapy and chemotherapy
Interventions
BIOLOGICALCamrelizumab
200mg iv Q3W
DRUGFluzoparib
150mg bid
DRUGCisplatin，Pemetrexed
Cisplatin 75mg/m2 IV and Pemetrexed 500mg/m2 IV Q3W (Day 1 of each cycle of cycles 1-3) (non-squamous cell carcinoma only)
DRUGCisplatin，Etoposide
Cisplatin 50mg/m2 IV (the 1st and 8th days of the 1st cycle and the 2nd cycle; the 8th and 15th days of the 3rd cycle); Etoposide 50mg/m2 IV (the 1st cycle And the 1st to the 5th day of the 2nd cycle; the 8th to the 12th day of the 3rd cycle).
DRUGCarboplatin, Albumin Paclitaxel
Carboplatin AUC=6, Albumin Paclitaxel 100mg/m2 IV; Days 1, 8 and 15 of cycles 1, 2, and 3.
RADIATIONRadiotherapy
60 Gy (total 6 weeks)
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject type and disease characteristics 1. Suffer from NSCLC diagnosed by pathology (histology or cytology). 2. Have stage IIIA, IIIB, or IIIC NSCLC diagnosed according to the 8th edition of the American Joint Committee on Cancer. 3. It is confirmed and recorded by the multidisciplinary oncology committee or the treating physician and the thoracic surgeon to have stage III NSCLC that cannot accept radical surgery. 4. In whole-body fluorodeoxyglucose (FDG)-PET or FDG-PET/CT and diagnostic-quality CT or MRI scans of the chest, abdomen, pelvis, and brain, there is no evidence of metastatic disease as stage IV NSCLC. Note: Unless otherwise proven, the presence of pleural/pericardial effusion is considered to indicate metastatic disease. For the presence of pleural effusion in both the CT chest scan and the chest X-ray in the front view, thoracentesis is required to confirm that the pleural effusion is cytologically negative. Exclude participants whose effusion is exudate, even if the effusion is cytologically negative. Subjects who have met the remaining inclusion/
Exclusion criteria
and whose pleural effusion is not visible on chest X-rays in the front and side views, or who have too little effusion to be safely extracted can enter the study. 5. Suffer from a measurable disease defined by RECIST 1.1, and at least one lesion is suitable as a target lesion (determined by the investigator/imaging review of the local research center). 6. No previous treatment (chemotherapy, targeted therapy or radiotherapy) for stage III NSCLC. 7. A tumor tissue sample (tissue biopsy \[thick needle biopsy, excision biopsy, or excision biopsy\]) is provided. The tissue block of FFPE is better than the slice. The newly obtained tumor sample is better than archived tissue and should be obtained before chest imaging at screening. Note: If an unstained section is submitted, the new section must be submitted to the testing laboratory within 14 days of preparation. 8. The ECOG performance status assessed within 7 days before the first dose of the study intervention is 0 or 1 point. 9. The life expectancy is at least 6 months. 10. Sufficient PFT is defined as FEV1\> 50% of predicted normal expiratory volume and lung carbon monoxide diffusion volume (DLCO)\> 40% of predicted normal value. For subjects without DLCO measurement values, if the measured pulse oximetry (O2 saturation) in indoor air is ≥90%, it will be deemed to have sufficient oxygen transmission. 11. Have adequate organ functions, as defined in Table 1; all laboratory tests during the screening period should be completed 10 days before the start of the research intervention. 1. ANC ≥ 1.5×109/L; 2. HB ≥ 90 g/L; 3. PLT ≥ 100×109/L; The biochemical inspection must meet the following standards: 1. TBIL ≤ 1.5ULN; 2. ALT, AST≤ 2.5 ULN; 3. Serum creatinine sCr≤1.5ULN, endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula); 4. Coagulation function must meet: INR≤1.5 and APTT≤1.5ULN; 5. Heart color Doppler ultrasound LVEF≥50% Demographics 12. Men or women who are at least 18 years old and up to 120 years old (including 18 and 120 years old) when signing the informed consent form. Male subjects The contraceptive measures used by men should comply with the local regulations regarding contraceptive measures participating in clinical research. 13. Male subjects must agree to take contraceptive measures during treatment and at least 180 days after the last dose of the study intervention. Note: Male subjects must avoid donating sperm during treatment and for at least 180 days after the last dose of the study intervention. Female subjects The contraceptive measures used by women should comply with local regulations regarding contraceptive measures participating in clinical research. 14. Female subjects who are not pregnant, are not breastfeeding, and meet at least one of the following conditions, can participate in the study: 1. Women of non-bearing age. or 2. Agree to take contraceptive measures during treatment and at least 180 days after the administration of the last study intervention Informed consent 15. Subjects (or their legal representatives, if applicable) provide written informed consent to participate in the study. Subjects may also need to provide informed consent for future biomedical research. However, subjects can only participate in the main experiment and not participate in future biomedical research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review | 2 year | PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review | 2 year | ORR is defined as the percentage of participants who have achieved a Complete Response (CR) or a Partial Response (PR) |
| Disease control rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review | 2 year | Disease control rate is the proportion of patients whose tumors have shrunk or stabilized for a certain period of time, including complete remission (CR), partial remission (PR) and stable (SD) cases |
| Overall Survival (OS) | 2 year | OS was defined as the time from randomization to death due to any cause. OS is presented. Censoring will be performed using the date of last known contact for those who are alive at the time of analysis. |
| Safety of drug application | 2 year | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
Countries
China
Contacts
Primary ContactLiu ningbo, PhD
Outcome results
None listed