RC148 Plus Platinum-Based Chemotherapy vs Tislelizumab Plus Platinum-Based Chemotherapy for First-Line Squamous Non-Small Cell Lung Cancer (sqNSCLC)
Randomized, Double-Blind, Multicenter Phase III Study of RC148 in Combination With Platinum-Based Chemotherapy Versus Tislelizumab in Combination With Platinum-Based Chemotherapy as First-Line Treatment for Advanced Squamous Non-Small Cell Lung Cancer
1 other identifier
interventional
574
1 country
66
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 nonsmall-cell-lung-cancer
Started Apr 2026
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2026
CompletedFirst Posted
Study publicly available on registry
February 18, 2026
CompletedStudy Start
First participant enrolled
April 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2029
April 20, 2026
February 1, 2026
1.7 years
February 10, 2026
April 15, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
PFS is assessed in accordance with RECIST v1.1
24 months
Secondary Outcomes (6)
Overall Survival (OS)
24 months
PFS (assessed by the investigator(s))
24 months
Objective Response Rate (ORR)
24 months
Duration of Response (DoR)
24 months
Time to Response (TTR)
24 months
- +1 more secondary outcomes
Study Arms (2)
RC148 Plus Platinum-Based Chemotherapy
EXPERIMENTALTislelizumab Plus Platinum-Based Chemotherapy
ACTIVE COMPARATORInterventions
RC148, Carboplatin, Paclitaxel
Tislelizumab, Carboplatin, Paclitaxel
Eligibility Criteria
You may qualify if:
- Voluntarily participate in the study and signed the Informed Consent Form (ICF).
- Be willing to and able to participate in the trial and comply with the follow up procedures;
- Male or female, aged 18-75 years.
- Expected survival ≥ 3 months.
- ECOG PS score 0 or 1.
- Histopathologically or cytologically confirmed locally advanced or metastatic NSCLC not eligible for curative treatment.
- No prior systemic anti-tumor treatment for advanced or metastatic squamous NSCLC.
- Sufficient cardiac, bone marrow, hepatic, renal, and coagulation function.
- 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.
- At least one measurable lesion outside of the brain according to the RECIST v1.1 criteria.
- A PD-L1 expression test report that meets the requirements must be provided before enrollment.
You may not qualify if:
- Histopathologically or cytologically confirmed non-squamous non-small cell lung cancer.
- Squamous NSCLC with known EGFR sensitive mutations and ALK fusions; squamous NSCLC with known driver gene for which first-line approved treatment options exist.
- Presence of active brain metastases.
- Imaging at screening shows obvious tumor necrosis and cavitation, and the investigator judges that participation in the study will cause bleeding risk.
- 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.
- 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.
- Prior systemic anti-tumor treatment other than chemotherapy and PD-1/PD-L1 antibodies.
- Systemic treatment with corticosteroids or other immunosuppressive drugs within 2 weeks before randomization.
- Use of any live or attenuated live vaccines within 4 weeks before randomization, or planned during the study.
- Participation in other clinical trials within 4 weeks before randomization.
- 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.
- Participants with history of severe coagulation dysfunction or current intake of anticoagulant drugs.
- Toxic reactions from prior anti-tumor treatment have not recovered to grade 0-1 as defined by CTCAE version 6.0.
- Severe acute or chronic infections.
- Active gastrointestinal bleeding, hemoptysis, peptic ulcer, or hemorrhagic events requiring intervention within 4 weeks before randomization; or presence of severe esophagogastric varices or epistaxis.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Cancer Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality, China
Chongqing Medical University First Affiliated Hospital
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Union Hospital Affiliated to Fujian Medical University
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Gansu Cancer Hospital
Lanzhou, Gansu, China
The First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, China
Dongguan People's Hospital
Dongguan, Guangdong, China
Cancer Hospital Affiliated to Guangzhou Medical University
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Sun Yat-sen University First Affiliated Hospital
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Cancer Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangzhou, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
The Fourth Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Cancer Hospital Affiliated to Harbin Medical University
Harbin, Heilongjiang, China
Anyang Cancer Hospital
Anyang, Henan, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Nanyang Second People's Hospital
Nanyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou
Zhengzhou, Henan, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
Zhongda Hospital Affiliated to Southeast University
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
The Second Affiliated Hospital of Air Force Medical University of the Chinese People's Liberation Army
Xi'an, Shaanxi, China
Affiliated Hospital of Binzhou Medical University
Binzhou, Shandong, China
Jinan Central Hospital
Jinan, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China
Affiliated Cancer Hospital of Xinjiang University
Ürümqi, Xinjiang, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2026
First Posted
February 18, 2026
Study Start
April 3, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
November 30, 2029
Last Updated
April 20, 2026
Record last verified: 2026-02