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Trial Title:
A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With NSCLC
NCT ID:
NCT05756972
Condition:
NSCLC
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Carboplatin
Pemetrexed
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
PM8002
Description:
IV infusion
Arm group label:
PM8002+Chemotherapy
Intervention type:
Drug
Intervention name:
Placebo
Description:
IV infusion
Arm group label:
Placebo+Chemotherapy
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
IV infusion
Arm group label:
PM8002+Chemotherapy
Arm group label:
Placebo+Chemotherapy
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
IV infusion
Arm group label:
PM8002+Chemotherapy
Arm group label:
Placebo+Chemotherapy
Summary:
PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This is a phase II/III 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:
The study is divided into two parts. The first part is a phase II, single-arm study,
which is planned to enroll 60 subjects. The second part is a phase III randomized,
double-blind, placebo-controlled study. The study plans to enroll 314 subjects, who will
be randomized in a 1:1 ratio to an experimental group of PM8002 in combination with
chemotherapy (pemetrexed and carboplatin) and a control group of chemotherapy (pemetrexed
and carboplatin).
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Medical Ethics Committee of Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Zip:
519041
Country:
China
Start date:
June 26, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Biotheus Inc.
Agency class:
Industry
Source:
Biotheus Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05756972
