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A Study of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)

RecruitingPhase 2Ages 18 Years - 75 YearsAllSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB571 Combination Therapy in participants with Non-Small Cell Lung Cancer (NSCLC).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Male or female, age โ‰ฅ 18 years and โ‰ค 75 years at the time of signing the informed consent form (ICF). 2. Participants must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC). 3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Life expectancy โ‰ฅ 12 weeks as assessed by the investigator. 6. Adequate organ and bone marrow function. 7. Male and female participants must agree to use highly effective methods of contraception during the study treatment period. 8. Participants must voluntarily join this study, sign the ICF, and be able to comply with the visits and related procedures specified in the protocol. Exclusion Criteria: 1. Participants with other malignant tumors within 3 years before the first dose of study treatment. 2. Active or untreated central nervous system (CNS) metastasis. 3. Current uncontrolled concomitant diseases 4. Clinically severe lung damage due to complications of lung disorder 5. Participants with a history of interstitial lung disease (ILD)/non-infectious pneumonitis 6. A history of severe skin diseases 7. Unresolved toxicity from prior anti-tumor therapy 8. Serious infection within 4 weeks before the first dose of study treatment 9. Known active pulmonary tuberculosis. 10. Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study. 11. Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant. 12. Pregnant or breastfeeding women. 13. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.
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What it tests

  • SKB571 for injection
  • Osimertinib
  • Furmonertinib
  • carboplatin
  • Cisplatin
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Where

27 sites
Peking University Cancer Hospital
Beijing, China
Xinqiao Hospital of Army Medical University
Chongqing, China
Fujian Provincial Cancer Hospital
Fuzhou, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Dongguan People's Hospital
Dongguan, China
Sun Yat-sen University Cancer Center
Guangzhou, China
Guangzhou Medical University First Affiliated Hospital
Guangzhou, China
Guilin Medical University First Affiliated Hospital
Guilin, China

โ€ฆand 19 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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