Advanced or metastatic non-squamous non-small cell lung cancer with negative driver genes
Conditions
Interventions
Test group:Injection of HS-20093 group combined with Adalimumab
Control group :Docetaxel Injection
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. When signing the ICF, the age should be 18 years or above, and there is no restriction on gender. 2. Voluntarily participate in this clinical trial, understand the research procedures, and be able to sign the ICF in person. Also, commit to complying with all the requirements stipulated in this clinical trial protocol. 3. Advanced or metastatic non-squamous non-small cell lung cancer (stage IIIB/III C/IV, tumor staging according to the 9th edition of the AJCC staging system). Previously received advanced first-line standard systemic treatment based on platinum-containing chemotherapy and subsequently progressed or relapsed; as assessed by the investigators, they are eligible to participate in this study. 4. Provide a qualified genetic test report certifying that no the following gene mutations are carried, including: EGFR sensitive mutations, ALK fusion mutations, and ROS1 fusion mutations. If the genetic test report is unavailable or (unqualified), a sufficient amount of tumor tissue samples must be provided for genetic testing (please refer to the 6th item of the inclusion criteria); at the same time, based on the existing data, there is no evidence of other driver gene mutations. 5. According to RECIST v1.1, each participant must have at least one target lesion. Measurable lesions that have progressed after radiotherapy and have been confirmed can be regarded as target lesions. 6. Prioritize the provision of fresh tumor tissue samples (sample type: formalin-fixed, paraffin-embedded [FFPE] tumor tissue blocks or FFPE sections). The samples must be sufficient for the central laboratory to conduct PD-L1 expression testing and tumor gene testing (such as if the genetic test report is unavailable or unqualified), as well as subsequent biomarker analysis (such as B7-H3, provided the sample is sufficient); if fresh samples are not available, prepared FFPE sections from newly prepared FFPE tumor tissue blocks within 2 years are acceptable. If the tumor tissue samples are older than 2 years, they can be included in the study upon agreement with the sponsor. 7. The Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 to 1. 8. The minimum expected survival period is more than 12 weeks. 9. The organ functions are normal. Within 7 days before the study administration, the following laboratory limits must be met: a) Neutrophil count >= 1.5×10^9/L (without G-CSF correction/support treatment in the past 2 weeks); b) Platelet count >= 100×10^9/L (without blood transfusion correction/support treatment in the past 1 week); c) Hemoglobin >= 90 g/L (hemoglobin must meet the condition of no use of erythropoietin and no red blood cell transfusion in the past 2 weeks); d) Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ULN and/or AST and/or ALT > 3.5×ULN, combined with alkaline phosphatase (ALP) > 6×ULN (without correction treatment 7 days before laboratory test); f) Creatinine = 50 mL/min (calculated by Cockcroft-Gault formula in Appendix 12.4); g) Serum albumin (ALB) >= 28 g/
Exclusion criteria
Exclusion criteria: 1. The previous pathological diagnosis was for mixed-type non-small cell lung cancer (such as mixed small cell lung cancer and non-small cell lung cancer, mixed squamous cell carcinoma and adenocarcinoma) or any transformed type non-small cell lung cancer (small cell lung cancer transformed into non-small cell lung cancer); 2. Have received or are currently receiving the following treatments: a) Have used or are using treatments targeting B7-H3, such as MGC018, DS-7300a, ABBV-155, BAT8009, Enoblituzumab, and Omburtamab, etc.; b) Have used or are using topoisomerase I inhibitor drugs for treatment, including antibody-drug conjugates with topoisomerase I inhibitors as the payload, etc., such as topotecan, irinotecan, deruxtegravir, goserelin, Dato-Dxd (DS-1062), etc.; c) Have received docetaxel monotherapy or combination therapy with other drugs; d) Within the 2 weeks prior to randomization, have received cytotoxic chemotherapy drugs, experimental drugs, traditional Chinese medicine for anti-tumor indications (drug list is detailed in Appendix 12.1), or other anti-tumor drugs (including molecular targeted therapy or biological therapy, etc.); e) Within the 4 weeks prior to randomization, have received large molecule anti-tumor drug treatment (including immunotherapy, such as monoclonal antibody drugs and bispecific antibody drugs); f) Within the 2 weeks prior to randomization, have received local radiotherapy; within the 4 weeks prior to randomization, have received more than 30% bone marrow irradiation, or have received extensive radiotherapy; g) Have existing pleural effusion or peritoneal effusion that require clinical intervention (patients who do not need to drain the effusion or whose effusion stabilizes for more than 1 week after drainage can be enrolled); have pericardial effusion (patients with asymptomatic small amounts of pericardial effusion as evaluated by the investigator are allowed to be enrolled). If local anti-tumor drugs were used during drainage (such as intrathoracic perfusion), it is necessary to meet the requirement of at least 5 drug half-lives or 21 days (whichever is shorter) before randomization for enrollment; h) Within the 7 days prior to randomization, have used strong inhibitors of cytochrome P450 (CYP) 3A4, CYP2D6, P-gp, breast cancer resistance protein (BCRP), organic anion transporter polypeptide (OATP) 1B1 or OATP1B3; or have needed to continue receiving these drugs during the study (drug list is detailed in Appendix 12.1); i) Are currently receiving drugs known to prolong the QT interval or may cause torsades de pointes ventricular tachycardia; or need to continue receiving these drugs during the study (drug list and washout time are detailed in Appendix 12.1). 3. There are persistent adverse reactions caused by previous treatments, and these adverse reactions have not yet returned to grade 1 or the baseline state before the previous treatment, except for hair loss, hearing loss, vitiligo, stable endocrine diseases through alternative treatment, and grade 2 neuropathy. Or, after consultation with the sponsor, the researchers determined that these adverse reactions were not clinically relevant to the tolerance of the study intervention measures by the participants in the current clinical trial. 4. Untreated brain metastases; Uncontrolled brain metastases (unless there are no symptoms and no obvious edema around the tumor lesion on imaging, and no steroid treatment is required at least 2 weeks be
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival, PFS;Overall survival, OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;The incidence rate of AE;The proportion of patients with positive anti-HS-20093 ADA antibodies;Duration of Relief, DoR;Disease Control Rate, DCR;SAE severity;The proportion of patients who are positive for the anti-Adalimumab antibody (ADA);AE severity;The incidence rate of SAE; | — |
Countries
China
Contacts
Public ContactRen shengxiang
Shanghai Pulmonary Hospital
Outcome results
None listed