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RC148 plus platinum chemotherapy versus tislelizumab plus platinum chemotherapy for first-line squamous non-small cell lung cancer

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

PHASE3 · RemeGen Co., Ltd. · NCT07416474

This study tests whether RC148 with carboplatin and paclitaxel works better than tislelizumab with the same chemotherapy for people with newly diagnosed advanced or metastatic squamous non-small cell lung cancer who have not had prior systemic treatment.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment574 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorRemeGen Co., Ltd. (industry)
Drugs / interventionschemotherapy, immunotherapy, radiation, Tislelizumab
Locations66 sites (Hefei, Anhui and 65 other locations)
Trial IDNCT07416474 on ClinicalTrials.gov

What this trial studies

This Phase 3 trial enrolls adults with locally advanced or metastatic squamous non-small cell lung cancer who are treatment-naïve for advanced disease and have ECOG performance status 0–1. Participants receive either RC148 plus carboplatin and paclitaxel or tislelizumab plus carboplatin and paclitaxel and are treated until disease progression or the end of study treatment. The study collects safety and anti-cancer activity data to compare the two regimens. Key eligibility requirements include adequate cardiac, bone marrow, hepatic, renal and coagulation function and appropriate contraception for participants of childbearing potential.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–75 with histologically or cytologically confirmed locally advanced or metastatic squamous NSCLC, ECOG 0–1, no prior systemic therapy for advanced disease, and adequate organ function.

Not a fit: Patients with non-squamous NSCLC, prior first-line systemic treatment for advanced disease, poor performance status, or inadequate organ function are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, RC148 combined with platinum chemotherapy could provide better disease control or survival than an established immunotherapy-plus-chemotherapy option.

How similar studies have performed: Other trials combining PD-1/PD-L1 immune checkpoint inhibitors with platinum-doublet chemotherapy in first-line advanced NSCLC have shown improved outcomes, so this trial builds on established clinical evidence.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Hefei, Anhui and 65 other locations

+16 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Non-Small Cell Lung Cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.