SCLC
Conditions
Keywords
Second-line
Brief summary
PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with Paclitaxel as second-line treatment for SCLC
Detailed description
This multicenter, randomized, open-label phase III study will evaluate the efficacy and safety of PM8002 in combination with Paclitaxel versus Investigator's Choice (Topotecan or Paclitaxel) as second-line treatment for subjects with SCLC.
Interventions
DRUGPM8002
Following a predefined dose and date.
DRUGPaclitaxel
175mg/m2 via IV infusion on Day 1 Q3W
DRUGTopotecan
1.25mg/m2/day via IV infusion on Days 1-5 Q3W
Sponsors
Biotheus Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntary participation in this clinical study; full understanding of the study and voluntary signing the informed consent form; willing to follow and abling to complete all trial procedures; 2. Age ≥18 years but ≤75 years; 3. Histologically or cytologically confirmed SCLC; 4. Advanced SCLC that has progressed or replased after first-line platinum-containing chemotherapy (extensive-stage patients must have received immune checkpoint inhibitors); 5. Having adequate organ functions; 6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1; 7. Life expectancy of 12 weeks or more; 8. Having at least one measurable tumor lesion according to RECIST v1.1;
Exclusion criteria
1. History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs; 2. Previous treatment with Paclitaxel or Topotecan or anti-vascular endothelial growth factor (VEGF) target drugs; 3. Current presence of severe superior vena cava syndrome and spinal cord compression; 4. Adverse events resulting from prior anti-tumor therapies should be assessed and graded according to the CTCAE 5.0 criteria, subjects whose AEs have not returned to Grade 1 or below; 5. Evidence of significant clotting disorder or other significant bleeding risk; 6. History of severe, uncontrollable, or active cardiovascular diseases within 6 months; 7. Current presence of uncontrollable pleural, pericardial, and peritoneal effusions; 8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome; 9. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation; 10. History of alcohol abuse, psychotropic substance abuse or drug abuse; 11. Pregnant or lactating women; 12. Other conditions considered unsuitable for this study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Up to approximately 32 months from first patient in | Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis are censored at the date of the last follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) evaluated by investigator | Up to approximately 32 months from first patient in | ORR is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by investigators based on RECIST 1.1 is presented. |
| Disease control rate (DCR) | Up to approximately 32 months from first patient in | DCR is defined as the sum rate of CR, PR and Stable Disease (SD), as determined by investigators based on RECIST v1.1 |
| Time to response (TTR) | Up to approximately 32 months from first patient in | Time to response(TTR) is defined as the time from randomization to the first documented PR or CR assssed by investigator based on RECIST v1.1 |
| Duration of response (DOR) | Up to approximately 32 months from first patient in | DoR is defined as the time period from the date of initial CR or PR until the date of PD or death due to any cause, whichever occurs first. |
| 6 month PFS rate | Up to approximately 32 months from first patient in | PFS rate corresponding to the 6th month of the progression-free survival curve |
| Progression-Free Survival (PFS) assessed by evaluated by investigator | Up to approximately 32 months from first patient in | PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by investigator or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. |
| 12 month OS rate | Up to approximately 32 months from first patient in | OS rate corresponding to the 12th month of the overall survival curve |
| Incidence and severity of Adverse Event (AE) according to CTCAE 5.0 | Up to 30 days after last treatment | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. |
| Anti-drug antibody (ADA) | Up to 30 days after last treatment | To evaluate the incidence and characteristics of ADA to PM8002 |
| Health related quality of life (HRQoL) | Up to 30 days after last treatment | Differences in the scores of health-related quality of life (HRQol) |
| 12 month PFS rate | Up to approximately 32 months from first patient in | PFS rate corresponding to the 12th month of the progression-free survival curve |
Countries
China
Contacts
Primary ContactJia Song
Outcome results
None listed