RC148 Plus Platinum-Based Chemotherapy vs Tislelizumab Plus Platinum-Based Chemotherapy for First-Line Squamous Non-Small Cell Lung Cancer (sqNSCLC)

July 12, 2026 updated by: RemeGen Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

574

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Baoding, China
        • Recruiting
        • Affiliated Hospital of Hebei University
      • Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital
      • Binzhou, China
        • Recruiting
        • The First People's Hospital of Chenzhou City
      • Cangzhou, China
        • Recruiting
        • Cangzhou Central Hospital
      • Changsha, China
        • Recruiting
        • Xiangya Hospital of Central South University
      • Chongqing, China
        • Recruiting
        • The Second Affiliated Hospital of Army Medical University of the Chinese People's Liberation Army
      • Shanghai, China
        • Recruiting
        • Shanghai Chest Hospital
      • Shanghai, China
        • Recruiting
        • Shanghai Pulmonary Hospital
      • Taiyuan, China
        • Recruiting
        • The First Hospital of Shanxi Medical University
      • Tianjin, China
        • Recruiting
        • Tianjin Medical University General Hospital
      • Wuhan, China
        • Recruiting
        • Hubei Cancer Hospital
      • Wuhan, China
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technolo
      • Wuhu, China
        • Recruiting
        • The First Affiliated Hospital of Wannan Medical College
      • Zhuzhou, China
        • Recruiting
        • ZhuZhou Central Hospital
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Peking University Cancer Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • The Second Affiliated Hospital of Chongqing Medical University
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • Cancer Hospital Affiliated to Chongqing University
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • Chongqing Medical University First Affiliated Hospital
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Cancer Hospital
      • Fuzhou, Fujian, China
        • Recruiting
        • Union Hospital affiliated to Fujian Medical University
      • Xiamen, Fujian, China
        • Recruiting
        • The first affiliated hospital of xiamen university
    • Gansu
      • Lanzhou, Gansu, China
        • Recruiting
        • The First Affiliated Hospital of Lanzhou University
    • Guangdong
      • Dongguan, Guangdong, China
        • Recruiting
        • Dongguan People's Hospital
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen University Cancer Center
      • Guangzhou, Guangdong, China
        • Recruiting
        • ZhuJiang Hospital of Southern Medical University
      • Guangzhou, Guangdong, China
        • Recruiting
        • Cancer Hospital Affiliated to Guangzhou Medical University
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen University First Affiliated Hospital
      • Jiangmen, Guangdong, China
        • Recruiting
        • Jiangmen Central Hospital
      • Shenzhen, Guangdong, China
        • Recruiting
        • Shenzhen People's Hospital
      • Zhuhai, Guangdong, China
        • Recruiting
        • The Fifth Affiliated Hospital of Sun Yat-Sen University
    • Guangxi
      • Guilin, Guangxi, China
        • Recruiting
        • The Second Affiliated Hospital of Guilin Medical University
      • Nanning, Guangxi, China
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
      • Nanning, Guangxi, China
        • Recruiting
        • Cancer Hospital Affiliated to Guangxi Medical University
    • Guangzhou
      • Guangzhou, Guangzhou, China
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
    • Guizhou
      • Guiyang, Guizhou, China
        • Recruiting
        • Guizhou Provincial People's Hospital
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • The Fourth Affiliated Hospital of Hebei Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • Cancer Hospital Affiliated to Harbin Medical University
    • Henan
      • Anyang, Henan, China
        • Recruiting
        • Anyang Cancer Hospital
      • Luoyang, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
      • Nanyang, Henan, China
        • Recruiting
        • Nanyang Second People's Hospital
      • Xinxiang, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Xinxiang Medical University
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Cancer Hospital
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Provincial People's Hospital
      • Zhengzhou, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Zhongnan Hospital of Wuhan University
      • Xiangyang, Hubei, China
        • Recruiting
        • Xiangyang Central Hospital
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Cancer hospital
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Provincial People's Hospital
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Cancer Hospital
      • Nanjing, Jiangsu, China
        • Recruiting
        • Zhongda Hospital Affiliated to Southeast University
      • Suzhou, Jiangsu, China
        • Recruiting
        • The First Affiliated Hospital of Soochow University
      • Xuzhou, Jiangsu, China
        • Recruiting
        • Xuzhou Central Hospital
      • Xuzhou, Jiangsu, China
        • Recruiting
        • Affiliated Hospital of Xuzhou Medical University
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • The First Affiliated Hospital of NanChang University
      • Nanchang, Jiangxi, China
        • Recruiting
        • Jiangxi Cancer Hospital
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • Jilin cancer hospital
    • Liaoning
      • Shenyang, Liaoning, China
        • Recruiting
        • The First Affiliated Hospital of China Medical University
      • Shenyang, Liaoning, China
        • Recruiting
        • Liaoning Cancer Hospital
    • Ningxia
      • Yinchuan, Ningxia, China
        • Recruiting
        • General Hospital of Ningxia Medical University
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Recruiting
        • The Second Affiliated Hospital of Air Force Medical University of the Chinese People's Liberation Army
    • Shandong
      • Binzhou, Shandong, China
        • Recruiting
        • Affiliated Hospital of Binzhou Medical University
      • Jinan, Shandong, China
        • Recruiting
        • Jinan Central Hospital
      • Linyi, Shandong, China
        • Recruiting
        • Linyi Cancer Hospital
      • Qingdao, Shandong, China
        • Recruiting
        • Affiliated Hospital of Qingdao University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Fudan University Shanghai Cancer Center
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Shanghai Pulmonary Hospital
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • Shanxi Cancer Hospital
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • Sichuan Cancer Hospital
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital of Sichuan University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Recruiting
        • Tianjin Chest Hospital
      • Tianjin, Tianjin Municipality, China
        • Recruiting
        • Tianjin cancer hospital
    • Xinjiang
      • Ürümqi, Xinjiang, China
        • Recruiting
        • Affiliated Cancer Hospital of Xinjiang University
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • Yunnan Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
      • Taizhou, Zhejiang, China
        • Recruiting
        • Taizhou Hospital of Zhejiang Province
      • Wenzhou, Zhejiang, China
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RC148 Plus Platinum-Based Chemotherapy
Drug: RC148 plus Carboplatin and Paclitaxel
RC148, Carboplatin, Paclitaxel
Other Names:
  • RC148 plus Platinum-Based Chemotherapy
Active Comparator: Tislelizumab Plus Platinum-Based Chemotherapy
Drug: Tislelizumab plus Carboplatin and Paclitaxel
Tislelizumab, Carboplatin, Paclitaxel
Other Names:
  • Tislelizumab plus Platinum-Based Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: 24 months
PFS is assessed in accordance with RECIST v1.1
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS (assessed by the investigator(s))
Time Frame: 24 months
PFS assessed by the investigator(s) is assessed in accordance with RECIST v1.1
24 months
Overall Survival (OS)
Time Frame: 24 months
OS
24 months
Objective Response Rate (ORR)
Time Frame: 24 months
ORR is assessed in accordance with RECIST v1.1
24 months
Duration of Response (DoR)
Time Frame: 24 months
DoR is assessed in accordance with RECIST v1.1
24 months
Time to Response (TTR)
Time Frame: 24 months
TTR is assessed in accordance with RECIST v1.1
24 months
Treatment-Emergent Adverse Event (TEAE)
Time Frame: 46 months
Adverse events during treatment
46 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RemeGen Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

November 30, 2029

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 12, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC148-C301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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