Study of SKB264 to treat participants with advanced non-small cell lung cancer alone or as a combination treatment
- Conditions
- Advanced or Metastatic Non-small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-507270-41-00
- Lead Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 278
Subjects must be at least 18 years of age on day of signing informed consent, regardless of gender., Left ventricular ejection fraction (LVEF)= 50% by echocardiogram (ECHO) or multiple-gated acquisition (MUGA)., Subjects must have recovered from all toxicities led by prior treatment (recover to < Grade 2 based on CTCAE 5.0 criteria, or to levels defined in the eligibility criteria) with the exception of toxicities not considered a safety risk (e.g. alopecia, vitiligo, and other asymptomatic laboratory abnormalities), Contraceptive methods used by male and female subjects must comply with contraceptive methods of local regulations for clinical study subjects, Subjects should voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol- specified visits and relevant procedures., Subjects with histologically or cytologically confirmed NSCLC, locally advanced (stage IIIB/IIIC) or metastatic (Stage IV) NSCLC not amenable to receive definitive surgery and/or radiotherapy (with or without concurrent chemotherapy), according to TNM staging of lung cancer published by the International Union Against Cancer and American Joint Committee on Cancer, 8th edition., EGFR wild-type cohorts: for subjects with non-squamous or mixed histology NSCLC should be confirmed by tumor histology to be EGFR wild- type and ALK fusion gene negative; without known alterations of driver genes such as ROS1, NTRK, and BRAF; without actionable genomic alterations for other approved targetable therapies. For subjects with squamous NSCLC, if the prior EGFR and ALK status is unknown, the corresponding tests are not required prior to enrollment in this study and the gene status will be considered negative. EGFR mutation cohorts: subjects should be confirmed by tumor histology, cytology or blood sample to harbor EGFR exon 19 deletion mutation or exon 21 L858R mutation., The study will include: a) Locally advanced or metastatic NSCLC subjects without actionable EGFR mutations and ALK fusion genes, without known ROS1, NTRK, BRAF gene alterations or other actionable gene mutation kinases with approved therapies. b) Locally advanced or metastatic NSCLC subjects without actionable EGFR mutations and ALK fusion genes, known ROS1, NTRK, BRAF gene alterations, or other actionable gene mutation kinases with approved therapies, who have not received prior systemic treatment including prior treatment with PD-1/PD-L1 antibodies. c) Subjects with EGFR exon 19 deletion mutation or exon 21 L858R, mutation who failed prior EGFR-TKI treatment, meeting all of the following criteria. d) Subjects with EGFR exon 19 deletion or exon 21 L858R mutation; no prior systemic treatment., Subjects are able to provide tumor blocks or slides before the first dose of study intervention., Subject must have at least one radiographically measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; brain metastatic lesion(s) will not be selected as target lesion., Subject has an ECOG performance status of either 0 or 1 as assessed within 7 days before initiation of study intervention, Life expectancy at least 3 months for the subject, Adequate organ function as indicated by the laboratory values. For further details please refer to protocol.
Subjects with mixed SCLC histopathological features, Subjects with uncontrolled systemic disease as judged by the Investigator: a) Subjects with uncontrolled hypertension under medication intervention (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg), history of unstable hypertension, or history of poorly compliant anti-hypertension treatment. b) Subjects with uncontrolled diabetes under medication intervention. c) Subjects with pleural effusion, pericardial effusion, or ascites that is clinically symptomatic or requires repeated drainage., Subjects with active autoimmune disease that required systemic treatment in the past 2 years (e.g., use of disease symptom relieving agents, corticosteroids or immunosuppressive drugs). Hormone replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is permitted., Subjects with active hepatitis B or hepatitis C., Subjects with known history of Human Immunodeficiency Virus (HIV), Subjects with known active tuberculosis., Subjects who have received any chemotherapy, radiotherapy, immunotherapy, or biologic therapy within 4 weeks before the first dose of study intervention; received small molecule TKIs, anti-tumor hormone therapy, systemic immune stimulators (including but not limited to interferon, and IL-2), or traditional Chinese medicine preparations approved for anti-tumor indications within 2 weeks or five half-lives prior to the first dose of study intervention; palliative radiation to known metastatic sites within 2 weeks prior to the first dose of study intervention., Subjects who have received other clinical investigational drugs or major surgery within 4 weeks prior to the first dose of study intervention., Subjects who have received radiation therapy to lung that is more than 30 Gy within 6 months prior to the first dose of study intervention., Subjects who required the systemic use of strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks or 5 half-life periods prior to the first dose of study intervention and during the study (strong inhibitors or inducers of CYP3A4 are not permitted in this study; Appendix 7 in the protocol listed some representatives, for medication outside of the listing, investigator’s evaluation is needed)., Subjects who have received continuous high-dose systemic corticosteroids within 2 weeks prior to the first dose of study intervention (low-dose corticosteroids, such as = CCI mg/day prednisone or equivalent, are permitted if the dose is stable for at least 4 weeks), or other immunosuppressive therapy., Subjects with a known history of prior malignancy unless the subject has undergone potentially curative therapy with no evidence of that disease recurrence for 3 years since initiation of that therapy, Subjects who have received a live or live-attenuated vaccine within 4 weeks prior to the first dose of study intervention, or are scheduled to receive live vaccines during the study, Subjects with serious infections within 4 weeks prior to the first dose of study intervention (including but not limited to comorbidity, sepsis or severe pneumonia that require hospitalization) or concomitant infections requiring systemic antibiotic treatment within 2 weeks prior to the first dose of study intervention., Subjects wi
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method