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

March 4, 2026 updated by: RemeGen Co., Ltd.

A Phase Ib, Multi-Cohort, Open-Label, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of RC148 Injection as Monotherapy or Combination Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer.

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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;

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Peking University Cancer Hospital
      • Beijing, Beijing Municipality, China
        • Beijing Tiantan Hospital of Capital Medical University
    • Guangdong
      • Foshan, Guangdong, China
        • Shunde Hospital of Southern Medical University
      • Foshan, Guangdong, China
        • The First People's Hospital of Shunde
      • Guangzhou, Guangdong, China
        • Sun Yat-sen University Cancer Center
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital of Guangzhou Medical University
      • Jiangmen, Guangdong, China
        • Jiangmen Central Hospital
    • Guangxi
      • Gulin, Guangxi, China
        • The Second Affiliated Hospital of Guilin Medical College
      • Nanning, Guangxi, China
        • Affiliated Cancer Hospital of Guangxi Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Harbin Medical University Cancer Hospital
    • Henan
      • Hanyang, Henan, China
        • Nanyang Second General Hospital
      • Xinxiang, Henan, China
        • The First Affiliated Hospital of Xinxiang Medical College
      • Zhengzhou, Henan, China
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China
        • Union Hospital Tongji Medical College Huazhong University Of Science And Technologe
    • Hunan
      • Changsha, Hunan, China
        • Hunan Cancer Hospital
    • Jiangsu
      • Xuzhou, Jiangsu, China
        • The Affiliated Hospital of Xuzhou Medical University
    • Liaoning
      • Shenyang, Liaoning, China
        • Shengjing Hospital Of China Medical University
    • Shandong
      • Binzhou, Shandong, China
        • Binzhou Medical University Hospital
      • Jinan, Shandong, China
        • Jinan Central Hospital
      • Linyi, Shandong, China
        • Linyi Cancer Hospital
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Tianjin Medical University Cancer Institute Hospital
    • Yunnan
      • Kunming, Yunnan, China
        • Yunnan Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang Cancer Hospital
      • Taizhou, Zhejiang, China
        • Taizhou Hospital of Zhejiang Province

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 with histopathologically or cytologically confirmed, unresectable locally advanced or metastatic NSCLC (stage IIIB//IIIC/IV according to the 8th edition of UICC/AJCC) and not amendable to curative surgery or radiation as assessed by investigator.

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 be vaccinated during the study (except for COVID-19 vaccine);
  4. Received immune checkpoint inhibitor (anti-PD-1/PD-L1/CTLA-4 antibody) or other immune checkpoint inhibitor treatment within 28 days prior to the first dose, or experienced prior permanent immunotherapy discontinuation due to immunotoxicity;
  5. Participated in other clinical trials and received other investigational anti-tumor therapy within 28 days prior to the first dose;
  6. Poor compliance and unable to complete the study procedures as assessed by investigator;
  7. Have any other medical conditions, abnormal physical examinations or laboratory examinations that would be suspected interfere with participation or evaluation of the trial or increase the risk to the participant, in view of the investigator.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AGA-, NSCLC without systemic therapy
Combination Therapy
Drug: RC148 plus Carboplatin and Paclitaxel/pemetrexed
RC148; Carboplatin; Paclitaxel; pemetrexed
Other Names:
  • RC148 Injection
Experimental: AGA-，PD-1+, NSCLC without systemic therapy
Monotherapy
Drug: RC148
RC148 Monotherapy
Other Names:
  • RC148 Injection
Experimental: EGFR mu, Non-squamous NSCLC after EGFR-TKIs treatment
Combination Therapy
Drug: RC148 plus Carboplatin and Paclitaxel/pemetrexed
RC148; Carboplatin; Paclitaxel; pemetrexed
Other Names:
  • RC148 Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: 24 months
Tumor assessment will be performed until radiographic disease progression, initiation of new anticancer therapy, withdrawal of consent, death, loss to follow-up, or other end of study criterion is met, whichever is earlier.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Control Rate (DCR)
Time Frame: 24 months
Tumor assessment will be performed until radiographic disease progression, initiation of new anticancer therapy, withdrawal of consent, death, loss to follow-up, or other end of study criterion is met, whichever is earlier.
24 months
Duration of Response (DOR)
Time Frame: 24 months
Tumor assessment will be performed until radiographic disease progression, initiation of new anticancer therapy, withdrawal of consent, death, loss to follow-up, or other end of study criterion is met, whichever is earlier.
24 months
Progression-free survival (PFS)
Time Frame: 24 months
Tumor assessment will be performed until radiographic disease progression, initiation of new anticancer therapy, withdrawal of consent, death, loss to follow-up, or other end of study criterion is met, whichever is earlier.
24 months
Overall survival (OS)
Time Frame: 24 months
Tumor assessment will be performed until radiographic disease progression, initiation of new anticancer therapy, withdrawal of consent, death, loss to follow-up, or other end of study criterion is met, whichever is earlier.
24 months
Number of participants with adverse events (AEs)
Time Frame: 24 months
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
24 months
Incidence of RC148 anti-drug antibody (ADA)
Time Frame: 24 months
Serum samples will be collected from participants for ADA analysis of RC148. The blood sampling time points and time windows are described in protocol
24 months
Maximum observed concentration (Cmax) of RC148
Time Frame: 24 months
Serum concentrations of RC148 in individual subjects at different time points after RC148 administration
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RemeGen Co., Ltd.

Investigators

  • Study Director: li zhang, Sun Yat-sen University

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)

March 13, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 12, 2025

First Posted (Actual)

March 19, 2025

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC148-C002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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