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

NOT_YET_RECRUITINGPHASE3

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

NCT07416474•RemeGen Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Exclusion Criteria

•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.
•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.
+24 more criteria

Locations (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

Key Dates

Start Date

March 31, 2026

Primary Completion Date

December 31, 2027

Completion Date

November 30, 2029

Last Updated

February 20, 2026

Enrollment

574

ESTIMATED participants

Conditions

Non-Small Cell Lung Cancer

Interventions

RC148 plus Carboplatin and Paclitaxel

DRUG

Tislelizumab plus Carboplatin and Paclitaxel

DRUG

Contacts

Yongfeng Yang

CONTACT

010-65384976 yongfeng.yang@remegen.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

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Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)