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Taking people in ChinaPhase 3

RC148 or tislelizumab with chemotherapy as first treatment for squamous non-small cell lung cancer

Compares RC148 with tislelizumab, both given with chemotherapy, in advanced squamous non-small cell lung cancer.

Key facts

Who runs it
RemeGen Co., Ltd.
Where
Anyang, Baoding, Beijing, Binzhou, Cangzhou, Changchun, Changsha, Chengdu, Chongqing, Dongguan, Fuzhou, Guangzhou, Guilin, Guiyang, Hangzhou, Harbin, Hefei, Jiangmen, Jinan, Kunming, Lanzhou, Linyi, Luoyang, Nanchang, Nanjing, Nanning, Nanyang, Qingdao, Shanghai, Shenyang, Shenzhen, Shijiazhuang, Suzhou, Taiyuan, Taizhou, Tianjin, Ürümqi, Wenzhou, Wuhan, Wuhu, Xi'an, Xiamen, Xiangyang, Xinxiang, Xuzhou, Yinchuan, Zhengzhou, Zhuhai, and Zhuzhou, ChinaSee the 77 sites
Trial code
Registry title
RC148 Plus Platinum-Based Chemotherapy vs Tislelizumab Plus Platinum-Based Chemotherapy for First-Line Squamous Non-Small Cell Lung Cancer (sqNSCLC)
Status
Recruiting
Phase
Phase 3
People taking part
574 people, planned
Started
3 Apr 2026
Expected to end
30 Nov 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • RC148 plus Carboplatin and Paclitaxel
  • Tislelizumab plus Carboplatin and Paclitaxel
Record updated
14 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with squamous non-small cell lung cancer that is locally advanced or has spread, who have not yet had treatment for advanced disease.

Age
18 to 75 years
Sex
Men and women can join
Disease stage
Squamous non-small cell lung cancer that is locally advanced or has spread, and cannot be treated with treatment meant to remove all of the disease. At least one measurable tumor outside the brain.
Earlier treatment
No earlier whole-body anti-cancer treatment for advanced or spread squamous lung cancer. Earlier immunotherapy is limited.
Biomarker or test result
A PD-L1 test report that meets the requirements must be provided before joining. People with known EGFR sensitive mutations or ALK fusions cannot join.

Main reasons for not taking part

  • Non-squamous lung cancer
  • Active brain metastases
  • Known EGFR sensitive mutations or ALK fusions
  • Earlier immunotherapy, with limited exceptions
  • Autoimmune disease, interstitial lung disease, or organ transplant

The registry criteria, word for word

Show all 40 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • Toxic reactions from prior anti-tumor treatment have not recovered to grade 0-1 as defined by CTCAE version 6.0
  • Active gastrointestinal bleeding, hemoptysis, peptic ulcer, or hemorrhagic events requiring intervention within 4 weeks before randomization; or presence of severe esophagogastric varices or epistaxis
  • Severe arterial/venous thrombotic events or cerebrovascular accidents within 6 months before randomization
  • History of gastrointestinal perforation and/or fistula, history of gastrointestinal obstruction within 6 months before randomization
  • 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
  • Histopathologically or cytologically confirmed non-squamous non-small cell lung cancer
  • Imaging at screening shows obvious tumor necrosis and cavitation, and the investigator judges that participation in the study will cause bleeding risk
  • 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
  • Participants with history of severe coagulation dysfunction or current intake of anticoagulant drugs
  • Severe acute or chronic infections
  • Active or clinically significant heart disease
  • 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
  • Presence of systemically diseases that are not stably controlled as judged by the investigator
  • Active or history of autoimmune diseases with potential for recurrence
  • Past history of other acquired or congenital immunodeficiency diseases or organ transplantation
  • Known hypersensitivity or delayed-type hypersensitivity to certain components of the study drug or similar drugs
  • 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
  • Local or systemic diseases not caused by malignant tumors, or diseases or symptoms secondary to tumors
  • Squamous NSCLC with known EGFR sensitive mutations and ALK fusions; squamous NSCLC with known driver gene for which first-line approved treatment options exist
  • 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
  • Presence of active brain metastases
  • Presence of symptomatic or intervention-requiring third-space effusions
  • Poor compliance and expected inability to cooperate with the completion of trial procedures

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in China

  • Anyang Cancer HospitalAnyang, ChinaContact: Yongfeng YangTaking people
  • Affiliated Hospital of Hebei UniversityBaoding, ChinaContact: Yongfeng YangTaking people
  • Peking Union Medical College HospitalBeijing, ChinaContact: Yongfeng YangTaking people
  • Peking University Cancer HospitalBeijing, ChinaContact: Yongfeng YangTaking people
  • Affiliated Hospital of Binzhou Medical UniversityBinzhou, ChinaContact: Yongfeng YangTaking people
  • The First People's Hospital of Chenzhou CityBinzhou, ChinaContact: Yongfeng YangTaking people
  • Cangzhou Central HospitalCangzhou, ChinaContact: Yongfeng YangTaking people
  • Jilin Cancer HospitalChangchun, ChinaContact: Yongfeng YangTaking people
  • Hunan Cancer HospitalChangsha, ChinaContact: Yongfeng YangTaking people
  • Xiangya Hospital of Central South UniversityChangsha, ChinaContact: Yongfeng YangTaking people
  • Sichuan Cancer HospitalChengdu, ChinaContact: Yongfeng YangTaking people
  • West China Hospital of Sichuan UniversityChengdu, ChinaContact: Yongfeng YangTaking people
  • Cancer Hospital Affiliated to Chongqing UniversityChongqing, ChinaContact: Yongfeng YangTaking people
  • Chongqing Medical University First Affiliated HospitalChongqing, ChinaContact: Yongfeng YangTaking people
  • The Second Affiliated Hospital of Army Medical University of the Chinese People's Liberation ArmyChongqing, ChinaContact: Yongfeng YangTaking people
  • The Second Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaContact: Yongfeng YangTaking people
  • Dongguan People's HospitalDongguan, ChinaContact: Yongfeng YangTaking people
  • Fujian Cancer HospitalFuzhou, ChinaContact: Yongfeng YangTaking people
  • Union Hospital Affiliated to Fujian Medical UniversityFuzhou, ChinaContact: Yongfeng YangTaking people
  • Cancer Hospital Affiliated to Guangzhou Medical UniversityGuangzhou, ChinaContact: Yongfeng YangTaking people
  • Sun Yat-sen University Cancer CenterGuangzhou, ChinaContact: Yongfeng YangTaking people
  • Sun Yat-sen University First Affiliated HospitalGuangzhou, ChinaContact: Yongfeng YangTaking people
  • The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaContact: Yongfeng YangTaking people
  • Zhujiang Hospital of Southern Medical UniversityGuangzhou, ChinaContact: Yongfeng YangTaking people
  • The Second Affiliated Hospital of Guilin Medical UniversityGuilin, ChinaContact: Yongfeng YangTaking people
  • Guizhou Provincial People's HospitalGuiyang, ChinaContact: Yongfeng YangTaking people
  • Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of MedicineHangzhou, ChinaContact: Yongfeng YangTaking people
  • Zhejiang Cancer HospitalHangzhou, ChinaContact: Yongfeng YangTaking people
  • Cancer Hospital Affiliated to Harbin Medical UniversityHarbin, ChinaContact: Yongfeng YangTaking people
  • The First Affiliated Hospital of Anhui Medical UniversityHefei, ChinaContact: Yongfeng YangTaking people
  • Jiangmen Central HospitalJiangmen, ChinaContact: Yongfeng YangTaking people
  • Jinan Central HospitalJinan, ChinaContact: Yongfeng YangTaking people
  • Yunnan Cancer HospitalKunming, ChinaContact: Yongfeng YangTaking people
  • The First Affiliated Hospital of Lanzhou UniversityLanzhou, ChinaContact: Yongfeng YangTaking people
  • LinYi Cancer HospitalLinyi, ChinaContact: Yongfeng YangTaking people
  • The First Affiliated Hospital of Henan University of Science and TechnologyLuoyang, ChinaContact: Yongfeng YangTaking people
  • Jiangxi Cancer HospitalNanchang, ChinaContact: Yongfeng YangTaking people
  • The First Affiliated Hospital of NanChang UniversityNanchang, ChinaContact: Yongfeng YangTaking people
  • Jiangsu Cancer HospitalNanjing, ChinaContact: Yongfeng YangTaking people
  • Jiangsu Provincial People's HospitalNanjing, ChinaContact: Yongfeng YangTaking people
  • Zhongda Hospital Affiliated to Southeast UniversityNanjing, ChinaContact: Yongfeng YangTaking people
  • Cancer Hospital Affiliated to Guangxi Medical UniversityNanning, ChinaContact: Yongfeng YangTaking people
  • The First Affiliated Hospital of Guangxi Medical UniversityNanning, ChinaContact: Yongfeng YangTaking people
  • Nanyang Second People's HospitalNanyang, ChinaContact: Yongfeng YangTaking people
  • Affiliated Hospital of Qingdao UniversityQingdao, ChinaContact: Yongfeng YangTaking people
  • Fudan University Shanghai Cancer CenterShanghai, ChinaContact: Yongfeng YangTaking people
  • Shanghai Chest HospitalShanghai, ChinaContact: Yongfeng YangTaking people
  • Shanghai Pulmonary HospitalShanghai, ChinaContact: Yongfeng YangTaking people
  • Liaoning Cancer HospitalShenyang, ChinaContact: Yongfeng YangTaking people
  • The First Affiliated Hospital of China Medical UniversityShenyang, ChinaContact: Yongfeng YangTaking people
  • Shenzhen People's HospitalShenzhen, ChinaContact: Yongfeng YangTaking people
  • The Fourth Affiliated Hospital of Hebei Medical UniversityShijiazhuang, ChinaContact: Yongfeng YangTaking people
  • The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaContact: Yongfeng YangTaking people
  • Shanxi Cancer hospitalTaiyuan, ChinaContact: Yongfeng YangTaking people
  • The First Hospital of Shanxi Medical UniversityTaiyuan, ChinaContact: Yongfeng YangTaking people
  • Taizhou Hospital of Zhejiang ProvinceTaizhou, ChinaContact: Yongfeng YangTaking people
  • Tianjin Cancer HospitalTianjin, ChinaContact: Yongfeng YangTaking people
  • Tianjin Chest HospitalTianjin, ChinaContact: Yongfeng YangTaking people
  • Tianjin Medical University General HospitalTianjin, ChinaContact: Yongfeng YangTaking people
  • Affiliated Cancer Hospital of Xinjiang UniversityÜrümqi, ChinaContact: Yongfeng YangTaking people
  • The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaContact: Yongfeng YangTaking people
  • Hubei Cancer HospitalWuhan, ChinaContact: Yongfeng YangTaking people
  • Union Hospital, Tongji Medical College, Huazhong University of Science and TechnoloWuhan, ChinaContact: Yongfeng YangTaking people
  • Zhongnan Hospital of Wuhan UniversityWuhan, ChinaContact: Yongfeng YangTaking people
  • The First Affiliated Hospital of Wannan Medical CollegeWuhu, ChinaContact: Yongfeng YangTaking people
  • The Second Affiliated Hospital of Air Force Medical University of the Chinese People's Liberation ArmyXi'an, ChinaContact: Yongfeng YangTaking people
  • The First Affiliated hospital of Xiamen UniversityXiamen, ChinaContact: Yongfeng YangTaking people
  • Xiangyang Central HospitalXiangyang, ChinaContact: Yongfeng YangTaking people
  • The First Affiliated Hospital of Xinxiang Medical UniversityXinxiang, ChinaContact: Yongfeng YangTaking people
  • Affiliated Hospital of Xuzhou Medical UniversityXuzhou, ChinaContact: Yongfeng YangTaking people
  • Xuzhou Central HospitalXuzhou, ChinaContact: Yongfeng YangTaking people
  • General Hospital of Ningxia Medical UniversityYinchuan, ChinaContact: Yongfeng YangTaking people
  • Henan Cancer HospitalZhengzhou, ChinaContact: Yongfeng YangTaking people
  • Henan Provincial People's HospitalZhengzhou, ChinaContact: Yongfeng YangTaking people
  • The First Affiliated Hospital of ZhengzhouZhengzhou, ChinaContact: Yongfeng YangTaking people
  • The Fifth Affiliated Hospital of Sun Yat-sen UniversityZhuhai, ChinaContact: Yongfeng YangTaking people
  • Zhuzhou Central HospitalZhuzhou, ChinaContact: Yongfeng YangTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • RC148 Plus Platinum-Based ChemotherapyTreatment being tested

    Treatment: RC148 plus Carboplatin and Paclitaxel

  • Tislelizumab Plus Platinum-Based ChemotherapyExisting treatment, for comparison

    Treatment: Tislelizumab plus Carboplatin and Paclitaxel

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
RC148 or tislelizumab with chemotherapy as first treatment for squamous non-small cell lung cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07416474, who can take part
Record updated
14 July 2026