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

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;

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.