Evaluating RC148 for advanced non-small cell lung cancer

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 is testing a new treatment called RC148, alone and with other drugs, to see if it helps people with advanced non-small cell lung cancer.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: RemeGen Co., Ltd. (Industry-sponsored)
• Drugs / interventions: immunotherapy, radiation
• Locations: 24 sites (Beijing, Beijing and 23 other locations)
• Trial ID: NCT06883630 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy, safety, pharmacokinetics, and immunogenicity of RC148 injection, both as a standalone treatment and in combination with Carboplatin and Paclitaxel or Pemetrexed, for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The primary objective is to determine how effective RC148 is in treating this condition. Participants will be closely monitored throughout the trial to evaluate their response to the treatment and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with unresectable locally advanced or metastatic NSCLC who have an expected survival of at least three months.

Not a fit: Patients with small cell lung cancer or those who have recently undergone major surgery or received immune checkpoint inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced non-small cell lung cancer.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in using combination therapies for advanced lung cancer.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing and 23 other locations

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

Study contacts

• Study coordinator: yongfeng yang

Conditions Non-Small Cell Lung Cancer