Non-Small Cell Lung Cancer
Conditions
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;
Interventions
DRUGRC148 plus Carboplatin and Paclitaxel/pemetrexed
RC148; Carboplatin; Paclitaxel; pemetrexed
DRUGRC148
RC148 Monotherapy
Sponsors
RemeGen Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
STUDY_DIRECTORli zhang
Sun Yat-sen University
Outcome results
None listed