Actively Recruiting
RC148 Plus Platinum-Based Chemotherapy vs Tislelizumab Plus Platinum-Based Chemotherapy for First-Line Squamous Non-Small Cell Lung Cancer (sqNSCLC)
Led by RemeGen Co., Ltd. · Updated on 2026-04-20
574
Participants Needed
66
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RC148 Plus Platinum-Based Chemotherapy vs Tislelizumab Plus Platinum-Based Chemotherapy for First-Line Squamous Non-Small Cell Lung Cancer (sqNSCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign the Informed Consent Form
- Willing and able to comply with trial and follow-up procedures
- Male or female aged 18 to 75 years
- Expected survival of at least 3 months
- ECOG performance status score of 0 or 1
- Histologically or cytologically confirmed locally advanced or metastatic squamous NSCLC not suitable for curative treatment
- No prior systemic anti-tumor treatment for advanced or metastatic squamous NSCLC
- Adequate heart, bone marrow, liver, kidney, and coagulation function
- Female participants must be postmenopausal, surgically sterilized, or have a negative pregnancy test within 7 days before first dose
- Female participants must agree to use approved contraception during treatment and for 6 months after
- Male participants must agree to use approved contraception during treatment and for 6 months after
- Must not donate eggs (females) or sperm (males) during treatment and for 6 months after
- At least one measurable lesion outside the brain according to RECIST v1.1
- Provide a PD-L1 expression test report meeting requirements before enrollment
You will not qualify if you...
- Non-squamous non-small cell lung cancer confirmed
- Squamous NSCLC with known EGFR sensitive mutations, ALK fusions, or driver genes with approved first-line treatments
- Active brain metastases present
- Tumor necrosis or cavitation posing bleeding risk
- Chest radiotherapy over 30Gy within 6 months prior to randomization
- Palliative local treatment for non-target lesions within 2 weeks prior to randomization
- Non-specific immunomodulatory treatment within 2 weeks prior to randomization
- Use of Chinese herbal medicine with anti-tumor effects within 1 week prior to randomization
- History of immunotherapy except under specific conditions
- Prior systemic anti-tumor treatments other than chemotherapy and PD-1/PD-L1 antibodies
- Systemic corticosteroids or immunosuppressive drugs within 2 weeks before randomization
- Live or attenuated vaccines within 4 weeks before randomization or planned during study
- Participation in other clinical trials within 4 weeks before randomization
- Major surgery, trauma, or interventional therapy within 4 weeks before randomization
- Minor surgery within 7 days before randomization
- History of severe coagulation dysfunction or current anticoagulant use
- Unrecovered toxic reactions from prior anti-tumor treatment
- Severe acute or chronic infections
- Active gastrointestinal bleeding or related severe conditions within 4 weeks before randomization
- Severe thrombotic events within 6 months before randomization
- Active or significant heart disease
- Past or current interstitial lung disease or related lung impairments
- Recent gastrointestinal perforation, fistula, or obstruction
- Uncontrolled systemic diseases
- Active or history of autoimmune diseases with recurrence risk
- History of immunodeficiency or organ transplantation
- Known hypersensitivity to study drug components
- Symptomatic or intervention-requiring third-space effusions
- Other malignant tumors within 5 years except cured tumors
- Poor compliance or expected inability to complete trial procedures
- Other diseases or conditions judged unsuitable by investigator
- Diseases or symptoms not caused by malignant tumors or secondary to tumors
- Prior severe immune-related adverse events from PD-1/L1 inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 66 locations
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
2
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
3
Cancer Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality, China
Actively Recruiting
4
Chongqing Medical University First Affiliated Hospital
Chongqing, Chongqing Municipality, China
Actively Recruiting
5
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
6
Fujian Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
7
Union Hospital Affiliated to Fujian Medical University
Fuzhou, Fujian, China
Actively Recruiting
8
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Actively Recruiting
9
Gansu Cancer Hospital
Lanzhou, Gansu, China
Actively Recruiting
10
The First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, China
Actively Recruiting
11
Dongguan People's Hospital
Dongguan, Guangdong, China
Actively Recruiting
12
Cancer Hospital Affiliated to Guangzhou Medical University
Guangzhou, Guangdong, China
Actively Recruiting
13
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
14
Sun Yat-sen University First Affiliated Hospital
Guangzhou, Guangdong, China
Actively Recruiting
15
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Actively Recruiting
16
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Actively Recruiting
17
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Actively Recruiting
18
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
Actively Recruiting
19
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Actively Recruiting
20
Cancer Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, China
Actively Recruiting
21
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Actively Recruiting
22
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangzhou, China
Actively Recruiting
23
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Actively Recruiting
24
The Fourth Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Actively Recruiting
25
Cancer Hospital Affiliated to Harbin Medical University
Harbin, Heilongjiang, China
Actively Recruiting
26
Anyang Cancer Hospital
Anyang, Henan, China
Actively Recruiting
27
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Actively Recruiting
28
Nanyang Second People's Hospital
Nanyang, Henan, China
Actively Recruiting
29
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Actively Recruiting
30
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
31
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Actively Recruiting
32
The First Affiliated Hospital of Zhengzhou
Zhengzhou, Henan, China
Actively Recruiting
33
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Actively Recruiting
34
Xiangyang Central Hospital
Xiangyang, Hubei, China
Actively Recruiting
35
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
36
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Actively Recruiting
37
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
Actively Recruiting
38
Zhongda Hospital Affiliated to Southeast University
Nanjing, Jiangsu, China
Actively Recruiting
39
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
40
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Actively Recruiting
41
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Actively Recruiting
42
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Actively Recruiting
43
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
44
Jilin Cancer Hospital
Changchun, Jilin, China
Actively Recruiting
45
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Actively Recruiting
46
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
47
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Actively Recruiting
48
The Second Affiliated Hospital of Air Force Medical University of the Chinese People's Liberation Army
Xi'an, Shaanxi, China
Actively Recruiting
49
Affiliated Hospital of Binzhou Medical University
Binzhou, Shandong, China
Actively Recruiting
50
Jinan Central Hospital
Jinan, Shandong, China
Actively Recruiting
51
Linyi Cancer Hospital
Linyi, Shandong, China
Actively Recruiting
52
Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Actively Recruiting
53
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
54
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
55
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
Actively Recruiting
56
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Actively Recruiting
57
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
58
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
59
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
60
Affiliated Cancer Hospital of Xinjiang University
Ürümqi, Xinjiang, China
Actively Recruiting
61
Yunnan Cancer Hospital
Kunming, Yunnan, China
Actively Recruiting
62
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
63
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
64
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
65
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Actively Recruiting
66
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Actively Recruiting
Research Team
Y
Yongfeng Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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