A Phase Ib Study of RC148 as Monotherapy or Combination for Locally Advanced or Metastatic NSCLC

Last updated: March 4, 2026
Sponsor: RemeGen Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Non-small Cell Lung Cancer

Treatment

RC148 plus Carboplatin and Paclitaxel/pemetrexed

RC148

Clinical Study ID

NCT06883630
RC148-C002
  • Ages 18-80
  • All Genders

Study Summary

This study will evaluate the efficacy, safety, pharmacokinetics and immunogenicity of RC148 injection as a single agent or in combination for the treatment of locally advanced or metastatic non-small cell lung cancer

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Voluntarily participate in the study and signed the ICF;

  2. Be willing to and able to act on the trial and the follow up procedures;

  3. Male or female, aged 18-80 years;

  4. Expected survival ≥ 3 months;

  5. ECOG PS score 0 or 1;

  6. All participants to be enrolled in cohorts 1-5 must be diagnosed withhistopathologically or cytologically confirmed, unresectable locally advanced ormetastatic NSCLC (stage IIIB//IIIC/IV according to the 8th edition of UICC/AJCC) andnot amendable to curative surgery or radiation as assessed by investigator.

Exclusion

Exclusion Criteria:

  1. Histopathologically or cytologically confirmed small cell lung cancer;

  2. Received major surgeries and still in recovery within 28 days before the first dose;

  3. Received any live vaccine within 28 days prior to the first dose or plan to bevaccinated during the study (except for COVID-19 vaccine);

  4. Received immune checkpoint inhibitor (anti-PD-1/PD-L1/CTLA-4 antibody) or otherimmune checkpoint inhibitor treatment within 28 days prior to the first dose, orexperienced prior permanent immunotherapy discontinuation due to immunotoxicity;

  5. Participated in other clinical trials and received other investigational anti-tumortherapy within 28 days prior to the first dose;

  6. Poor compliance and unable to complete the study procedures as assessed byinvestigator;

  7. Have any other medical conditions, abnormal physical examinations or laboratoryexaminations that would be suspected interfere with participation or evaluation ofthe trial or increase the risk to the participant, in view of the investigator.

Study Design

Total Participants: 121
Treatment Group(s): 2
Primary Treatment: RC148 plus Carboplatin and Paclitaxel/pemetrexed
Phase: 1
Study Start date:
March 13, 2025
Estimated Completion Date:
July 31, 2027

Study Description

Primary objective: to evaluate the efficacy of RC148 injection as monotherapy or combination therapy in patients locally advanced or metastatic non-small cell lung cancer;

Connect with a study center

  • Beijing Tiantan Hospital of Capital Medical University

    Beijing, Beijing Municipality
    China

    Site Not Available

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality
    China

    Site Not Available

  • Shunde Hospital of Southern Medical University

    Foshan, Guangdong
    China

    Site Not Available

  • The First People's Hospital of Shunde

    Foshan, Guangdong
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong
    China

    Site Not Available

  • The First affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong
    China

    Site Not Available

  • Jiangmen Central Hospital

    Jiangmen, Guangdong
    China

    Site Not Available

  • The Second Affiliated Hospital of Guilin Medical College

    Gulin, Guangxi
    China

    Site Not Available

  • Affiliated Cancer Hospital of Guangxi Medical University

    Nanning, Guangxi
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang
    China

    Site Not Available

  • Nanyang Second General Hospital

    Hanyang, Henan
    China

    Site Not Available

  • The First Affiliated Hospital of Xinxiang Medical College

    Xinxiang, Henan
    China

    Site Not Available

  • Henan cancer hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • Union Hospital Tongji Medical College Huazhong University Of Science And Technologe

    Wuhan, Hubei
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning
    China

    Site Not Available

  • Binzhou Medical University Hospital

    Binzhou, Shandong
    China

    Site Not Available

  • Jinan Central Hospital

    Jinan, Shandong
    China

    Site Not Available

  • Linyi Cancer Hospital

    Linyi, Shandong
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute Hospital

    Tianjin, Tianjin Municipality
    China

    Site Not Available

  • Yunnan Cancer Hospital

    Kunming, Yunnan
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang
    China

    Site Not Available

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang
    China

    Site Not Available

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