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Active, not recruiting Phase 1

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

NCT06883630 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2025-03-13
Last updated
2026-03-05

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

RC148 plus Carboplatin and Paclitaxel/pemetrexed →RC148 →

RC148 plus Carboplatin and Paclitaxel/pemetrexed: RC148; Carboplatin; Paclitaxel; pemetrexed

RC148: RC148 Monotherapy

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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Objective Response Rate (ORR) — 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.

Trial sites (24)

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

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06883630 on ClinicalTrials.gov ↗ ← All trials in China