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

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: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: RC148 plus Carboplatin and Paclitaxel; Drug: Tislelizumab plus Carboplatin and Paclitaxel

• Study Type: Interventional
• Enrollment (Estimated): 574
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yongfeng Yang; Phone Number: 010-65384976; Email: yongfeng.yang@remegen.com

Study Locations

• China
  • 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
    • Lanzhou, Gansu, China
      • Recruiting
      • Gansu Cancer Hospital
  • 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
      • The First Affiliated Hospital of Zhejiang University School of Medicine
    • 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

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

How is the study designed?

Design Details

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

Number of Arms

2

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

Collaborators and Investigators

• Sponsor: RemeGen Co., Ltd.

Study record dates

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): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Inorganic Chemicals; Coordination Complexes; Taxoids; Cyclodecanes; Diterpenes; Carboplatin; Paclitaxel; Platinum Compounds; tislelizumab
• 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