RC148 Plus Platinum-Based Chemotherapy vs Tislelizumab Plus Platinum-Based Chemotherapy for First-Line Squamous Non-Small Cell Lung Cancer (sqNSCLC)
Phase 3 – large-scale trial before approval
Conditions:
Non-Small Cell Lung Cancer
Sponsor: RemeGen Co., Ltd.
trial.available_in:
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Overview
This study aims to evaluate the efficacy and safety of RC148 combined with platinum-based chemotherapy versus Tislelizumab combined with platinum-based chemotherapy in participants with locally advanced or metastatic Squamous NSCLC who have not received first-line treatment. Participants will: Take RC148 or Tislelizumab combined with platinum-based chemotherapy until the end of the research.
Who can participate
Inclusion Criteria:
1. Voluntarily participate in the study and signed the Informed Consent Form (ICF).
2. Be willing to and able to participate in the trial and comply with the follow up procedures;
3. Male or female, aged 18-75 years.
4. Expected survival ≥ 3 months.
5. ECOG PS score 0 or 1.
6. Histopathologically or cytologically confirmed locally advanced or metastatic NSCLC not eligible for curative treatment.
7. No prior systemic anti-tumor treatment for advanced or metastatic squamous NSCLC.
8. Sufficient cardiac, bone marrow, hepatic, renal, and coagulation function.
9. Female participants must be postmenopausal, surgically sterilized, or of childbearing potential with a negative blood pregnancy test within 7 days before the first dose. Female participants must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment, and must not donate oocytes or breastfeed during this period. Male participants must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment, and must not donate sperm during this period.
10. At least one measurable lesion outside of the brain according to the RECIST v1.1 criteria.
11. A PD-L1 expression test report that meets the requirements must be provided before enrollment.
Exclusion Criteria:
1. Histopathologically or cytologically confirmed non-squamous non-small cell lung cancer.
2. Squamous NSCLC with known EGFR sensitive mutations and ALK fusions; squamous NSCLC with known driver gene for which first-line approved treatment options exist.
3. Presence of active brain metastases.
4. Imaging at screening shows obvious tumor necrosis and cavitation, and the investigator judges that participation in the study will cause bleeding risk.
5. Chest radiotherapy \> 30Gy within 6 months before randomization; palliative local treatment for non-target lesions within 2 weeks before randomization; non-specific immunomodulatory treatment within 2 weeks before randomization; Chinese herbal medicine or proprietary Chinese medicine treatment with anti-tumor indications within 1 week before randomization.
6. History of immunotherapy. Note: For adjuvant/neoadjuvant phases or curative radiotherapy/chemoradiotherapy, PD-L1/PD-1 antibody therapy should be administered only if recurrence or metastasis occurs more than 12 months after the completion of the last medication.
7. Prior systemic anti-tumor treatment other than chemotherapy and PD-1/PD-L1 antibodies.
8. Systemic treatment with corticosteroids or other immunosuppressive drugs within 2 weeks before randomization.
9. Use of any live or attenuated live vaccines within 4 weeks before randomization, or planned during the study.
10. Participation in other clinical trials within 4 weeks before randomization.
11. Major surgery, interventional therapy, or severe trauma within 4 weeks before randomization, or planned major surgery during the study; core needle biopsy or other minor surgery within 7 days before randomization.
12. Participants with history of severe coagulation dysfunction or current intake of anticoagulant drugs.
13. Toxic reactions from prior anti-tumor treatment have not recovered to grade 0-1 as defined by CTCAE version 6.0.
14. Severe acute or chronic infections.
15. Active gastrointestinal bleeding, hemoptysis, peptic ulcer, or hemorrhagic events requiring intervention within 4 weeks before randomization; or presence of severe esophagogastric varices or epistaxis.
16. Severe arterial/venous thrombotic events or cerebrovascular accidents within 6 months before randomization.
17. Active or clinically significant heart disease.
18. Past or current interstitial lung disease, drug-related pneumonia, radiation pneumonitis, severe impairment of lung function, or clinical manifestations or high-risk factors suspected of interstitial lung disease.
19. History of gastrointestinal perforation and/or fistula, history of gastrointestinal obstruction within 6 months before randomization.
20. Presence of systemically diseases that are not stably controlled as judged by the investigator.
21. Active or history of autoimmune diseases with potential for recurrence.
22. Past history of other acquired or congenital immunodeficiency diseases or organ transplantation.
23. Known hypersensitivity or delayed-type hypersensitivity to certain components of the study drug or similar drugs.
24. Presence of symptomatic or intervention-requiring third-space effusions.
25. Other malignant tumors within 5 years before the start of study drug administration, except for malignant tumors that are expected to be cured after treatment.
26. Poor compliance and expected inability to cooperate with the completion of trial procedures.
27. Past or current history of any other diseases, abnormal physical examination findings, or abnormal laboratory examination findings that, in the investigator's judgment, reasonably suggest that the participant has a disease or condition unsuitable for the use of the study drug.
28. Local or systemic diseases not caused by malignant tumors, or diseases or symptoms secondary to tumors.
29. For participants who have used PD-1/L1 inhibitors, prior occurrence of grade 3 or above irAE related to immunotherapy, irAE leading to permanent discontinuation of treatment, grade 2 immune-related cardiotoxicity, or irAE of any grade involving the nervous system or eyes; prior occurrence of adverse events requiring treatment with immunosuppressive drugs other than corticosteroids, or recurrence of adverse events during previous immunotherapy requiring systemic use of corticosteroids again.
Interventions
RC148 plus Carboplatin and Paclitaxel
DRUG
Tislelizumab plus Carboplatin and Paclitaxel
DRUG
Locations
66
China (66)
Anyang Cancer Hospital
Anyang , Henan
Peking University Cancer Hospital
Beijing , Beijing Municipality
Affiliated Hospital of Binzhou Medical University
Binzhou , Shandong
Jilin Cancer Hospital
Changchun , Jilin
Hunan Cancer Hospital
Changsha , Hunan
Sichuan Cancer Hospital
Chengdu , Sichuan
West China Hospital of Sichuan University
Chengdu , Sichuan
Cancer Hospital Affiliated to Chongqing University
Chongqing , Chongqing Municipality
Chongqing Medical University First Affiliated Hospital
Chongqing , Chongqing Municipality
The Second Affiliated Hospital of Chongqing Medical University
Chongqing , Chongqing Municipality
Dongguan People's Hospital
Dongguan , Guangdong
Fujian Cancer Hospital
Fuzhou , Fujian
Union Hospital Affiliated to Fujian Medical University
Fuzhou , Fujian
Cancer Hospital Affiliated to Guangzhou Medical University
Guangzhou , Guangdong
Sun Yat-sen University Cancer Center
Guangzhou , Guangdong
Sun Yat-sen University First Affiliated Hospital
Guangzhou , Guangdong
Zhujiang Hospital of Southern Medical University
Guangzhou , Guangdong
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou , Guangzhou
The Second Affiliated Hospital of Guilin Medical University
Guilin , Guangxi
Guizhou Provincial People's Hospital
Guiyang , Guizhou
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou , Zhejiang
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou , Zhejiang
Zhejiang Cancer Hospital
Hangzhou , Zhejiang
Cancer Hospital Affiliated to Harbin Medical University
Harbin , Heilongjiang
The First Affiliated Hospital of Anhui Medical University
Hefei , Anhui
Jiangmen Central Hospital
Jiangmen , Guangdong
Jinan Central Hospital
Jinan , Shandong
Yunnan Cancer Hospital
Kunming , Yunnan
Gansu Cancer Hospital
Lanzhou , Gansu
The First Affiliated Hospital of Lanzhou University
Lanzhou , Gansu
Linyi Cancer Hospital
Linyi , Shandong
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang , Henan
Jiangxi Cancer Hospital
Nanchang , Jiangxi
The First Affiliated Hospital of Nanchang University
Nanchang , Jiangxi
Jiangsu Cancer Hospital
Nanjing , Jiangsu
Jiangsu Provincial People's Hospital
Nanjing , Jiangsu
Zhongda Hospital Affiliated to Southeast University
Nanjing , Jiangsu
Cancer Hospital Affiliated to Guangxi Medical University
Nanning , Guangxi
The First Affiliated Hospital of Guangxi Medical University
Nanning , Guangxi
Nanyang Second People's Hospital
Nanyang , Henan
Affiliated Hospital of Qingdao University
Qingdao , Shandong
Fudan University Shanghai Cancer Center
Shanghai , Shanghai Municipality
Shanghai Pulmonary Hospital
Shanghai , Shanghai Municipality
Liaoning Cancer Hospital
Shenyang , Liaoning
The First Affiliated Hospital of China Medical University
Shenyang , Liaoning
Shenzhen People's Hospital
Shenzhen , Guangdong
The Fourth Affiliated Hospital of Hebei Medical University
Shijiazhuang , Hebei
The First Affiliated Hospital of Soochow University
Suzhou , Jiangsu
Shanxi Cancer Hospital
Taiyuan , Shanxi
Taizhou Hospital of Zhejiang Province
Taizhou , Zhejiang
Tianjin Cancer Hospital
Tianjin , Tianjin Municipality
Tianjin Chest Hospital
Tianjin , Tianjin Municipality
Affiliated Cancer Hospital of Xinjiang University
Ürümqi , Xinjiang
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou , Zhejiang
Zhongnan Hospital of Wuhan University
Wuhan , Hubei
The Second Affiliated Hospital of Air Force Medical University of the Chinese People's Liberation Army
Xi'an , Shaanxi
The First Affiliated Hospital of Xiamen University
Xiamen , Fujian
Xiangyang Central Hospital
Xiangyang , Hubei
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang , Henan
Affiliated Hospital of Xuzhou Medical University
Xuzhou , Jiangsu
Xuzhou Central Hospital
Xuzhou , Jiangsu
General Hospital of Ningxia Medical University
Yinchuan , Ningxia
Henan Cancer Hospital
Zhengzhou , Henan
Henan Provincial People's Hospital
Zhengzhou , Henan
The First Affiliated Hospital of Zhengzhou
Zhengzhou , Henan
The Fifth Affiliated Hospital of Sun Yat-sen University