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

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: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: RC148 plus Carboplatin and Paclitaxel/pemetrexed; Drug: RC148

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

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

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

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)	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)	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)	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)	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)	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)	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)	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	Serum concentrations of RC148 in individual subjects at different time points after RC148 administration	24 months

Collaborators and Investigators

• Sponsor: RemeGen Co., Ltd.
• Investigators: Study Director: li zhang, Sun Yat-sen University

Study record dates

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: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Diterpenes; Pemetrexed; Carboplatin; Paclitaxel
• 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