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

Last updated: March 21, 2025
Sponsor: RemeGen Co., Ltd.
Overall Status: Active - 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: 150
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
    China

    Active - Recruiting

  • Peking University Cancer Hospital

    Beijing, Beijing
    China

    Active - Recruiting

  • Shunde Hospital of Southern Medical University

    Foshan, Guangdong
    China

    Active - Recruiting

  • The First People's Hospital of Shunde

    Foshan, Guangdong
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • The First affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Jiangmen Central Hospital

    Jiangmen, Guangdong
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Guilin Medical College

    Gulin, Guangxi
    China

    Active - Recruiting

  • Affiliated Cancer Hospital of Guangxi Medical University

    Nanning, Guangxi
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang
    China

    Active - Recruiting

  • Nanyang Second General Hospital

    Hanyang, Henan
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xinxiang Medical College

    Xinxiang, Henan
    China

    Active - Recruiting

  • Henan cancer hospital

    Zhengzhou, Henan
    China

    Active - Recruiting

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

    Wuhan, Hubei
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan
    China

    Active - Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu
    China

    Active - Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning
    China

    Active - Recruiting

  • Binzhou Medical University Hospital

    Binzhou, Shandong
    China

    Active - Recruiting

  • Jinan Central Hospital

    Jinan, Shandong
    China

    Active - Recruiting

  • Linyi Cancer Hospital

    Linyi, Shandong
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute Hospital

    Tianjin, Tianjin
    China

    Active - Recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang
    China

    Active - Recruiting

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang
    China

    Active - Recruiting

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