A Phase Ib Study of RC148 as Monotherapy or Combination for Locally Advanced or Metastatic NSCLC
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Drug: RC148 plus Carboplatin and Paclitaxel/pemetrexed
- Registration Number
- NCT06883630
- Lead Sponsor
- RemeGen Co., Ltd.
- Brief 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
- 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;
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Voluntarily participate in the study and signed the ICF;
- Be willing to and able to act on the trial and the follow up procedures;
- Male or female, aged 18-80 years;
- Expected survival ≥ 3 months;
- ECOG PS score 0 or 1;
- 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.
- Histopathologically or cytologically confirmed small cell lung cancer;
- Received major surgeries and still in recovery within 28 days before the first dose;
- 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);
- 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;
- Participated in other clinical trials and received other investigational anti-tumor therapy within 28 days prior to the first dose;
- Poor compliance and unable to complete the study procedures as assessed by investigator;
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AGA-, NSCLC without systemic therapy RC148 plus Carboplatin and Paclitaxel/pemetrexed Combination Therapy AGA-，PD-1+, NSCLC without systemic therapy RC148 Monotherapy EGFR mu, Non-squamous NSCLC after EGFR-TKIs treatment RC148 plus Carboplatin and Paclitaxel/pemetrexed Combination Therapy
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Disease Control Rate (DCR) 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.
Duration of Response (DOR) 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.
Progression-free survival (PFS) 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.
Overall survival (OS) 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.
Number of participants with adverse events (AEs) 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.
Incidence of RC148 anti-drug antibody (ADA) 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
Maximum observed concentration (Cmax) of RC148 24 months Serum concentrations of RC148 in individual subjects at different time points after RC148 administration
Related Research Topics
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Trial Locations
- Locations (24)
Shunde Hospital of Southern Medical University
🇨🇳Foshan, Guangdong, China
Beijing Tiantan Hospital of Capital Medical University
🇨🇳Beijing, Beijing, China
Peking University Cancer Hospital
🇨🇳Beijing, Beijing, China
The First People's Hospital of Shunde
🇨🇳Foshan, Guangdong, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
The First affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Jiangmen Central Hospital
🇨🇳Jiangmen, Guangdong, China
The Second Affiliated Hospital of Guilin Medical College
🇨🇳Gulin, Guangxi, China
Affiliated Cancer Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Nanyang Second General Hospital
🇨🇳Hanyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical College
🇨🇳Xinxiang, Henan, China
Henan cancer hospital
🇨🇳Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University Of Science And Technologe
🇨🇳Wuhan, Hubei, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Binzhou Medical University Hospital
🇨🇳Binzhou, Shandong, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Linyi Cancer Hospital
🇨🇳Linyi, Shandong, China
Tianjin Medical University Cancer Institute Hospital
🇨🇳Tianjin, Tianjin, China
Yunnan Cancer Hospital
🇨🇳Kunming, Yunnan, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
🇨🇳Taizhou, Zhejiang, China