NSCLC
Conditions
Brief summary
PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This is a phase II study to evaluate the efficacy and safety of PM8002 in combination with pemetrexed and carboplatin in patients with EGFR-mutant locally advanced or metastatic non-squamous NSCLC who have failed to EGFR-TKI treatment.
Detailed description
This study is a phase II, single-arm study, 64 participants were enrolled as of 6 Feb 2024, and recruitment was completed.
Interventions
Sponsors
Biotheus Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent form before any trial-related processes. 2. Age ≥ 18 years male or female. 3. Have a histologically or cytologically confirmed stage IIIB/IIIC NSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic non-squamous NSCLC (IV). 4. with EGFR mutation confirmed by tumor histology or cytology or hematology prior to EGFR-TKI treatment. 5. EGFR-TKI resistance, confirmed by RECIST v1.1. 6. have adequate organ function. 7. The investigator confirms at least one measurable lesion according to RECIST v1.1. A measurable lesion located in the field of previous radiation therapy or after local treatment may be selected as a target lesion if progression is confirmed. 8. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1.
Exclusion criteria
1. Squamous cell \> 10%. If small cell types are present, the subject is not eligible for inclusion. 2. Have other driving gene mutations that can obtain effective treatment. 3. Have previously received systemic anti-tumor treatment other than EGFR-TKI for advanced non-squamous NSCLC. 4. Have received systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of study drugs. 5. Have received EGFR-TKI treatment, within 14 days prior to the first dose of study drugs 6. Anticoagulant or thrombolytic agent within 10 days prior to the first dose of study drugs. 7. Evidence and history of severe bleeding tendency or coagulation dysfunction. 8. The toxicity of previous anti-tumor therapy has not been alleviated. 9. Symptomatic central nervous system metastases (CNS) metastasis and/or cancerous meningitis. 10. Have suffered from the second primary active malignant tumor in the past 5 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | Up to approximately 2 years | Objective response rate is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response (DoR) | Up to approximately 2 years | DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first. |
| Anti-drug antibody(ADA) | Up to 30 days after last treatment | To evaluate the incidence of ADA to PM8002 |
| Treatment related adverse events (TRAEs) | Up to 30 days after last treatment | The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0 |
| Correlation between PD-L1 expression and antitumor effect | Up to approximately 2 years | To evaluate correlation between PD-L1 expression and antitumor effect |
| Progression free survival (PFS) | Up to approximately 2 years | Progression free survival is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1). |
| Overall survival (OS) | Up to approximately 2 years | OS is the time from the date of randomization or first dosing date to death due to any cause. |
| Disease control rate (DCR) | Up to approximately 2 years | DCR is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST v1.1. |
| Time to response (TTR) | Up to approximately 2 years | TTR is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieve CR or PR (based on RECIST v1.1). |
| Pharmacokinetic (PK) parameters | Up to 30 days after last treatment | The PK parameters include serum concentrations of PM8002 at different timepoints after study drug administration. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlation between PM8002 exposure, immunogenicity and safety | Up to 30 days after last treatment | To evaluate correlation between PM8002 exposure, immunogenicity and safety |
| Correlation between PM8002 exposure, immunogenicity and efficacy | Up to approximately 2 years | To evaluate correlation between PM8002 exposure, immunogenicity and efficacy |
| Population PK analysis | Up to 30 days after last treatment | To assess the Exposure-Response of PM8002 by means of population PK (popPK) analysis |
Countries
China
Outcome results
None listed