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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
574

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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