Clinical trial NCT05756972: A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With NSCLC
Official title: A Phase II Clinical Trial to Evaluate the Efficacy and Safety of PM8002(Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With EGFR-mutant Advanced Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: NSCLC
Lead sponsor: Biotheus Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: Up to approximately 2 years
measure: Overall survival (OS)
timeFrame: Up to approximately 2 years
measure: Disease control rate (DCR)
timeFrame: Up to approximately 2 years
measure: Duration of response (DoR)
timeFrame: Up to approximately 2 years
measure: Time to response (TTR)
timeFrame: Up to approximately 2 years
measure: Pharmacokinetic (PK) parameters
timeFrame: Up to 30 days after last treatment
measure: Anti-drug antibody(ADA)
timeFrame: Up to 30 days after last treatment
measure: Treatment related adverse events (TRAEs)
timeFrame: Up to 30 days after last treatment
measure: Correlation between PD-L1 expression and antitumor effect
timeFrame: Up to approximately 2 years
Other outcomes:
measure: Population PK analysis
timeFrame: Up to 30 days after last treatment
measure: Correlation between PM8002 exposure, immunogenicity and efficacy
timeFrame: Up to approximately 2 years
measure: Correlation between PM8002 exposure, immunogenicity and safety
timeFrame: Up to 30 days after last treatment
Locations:
city: Guangzhou
country: China
facility: Medical Ethics Committee of Guangdong Provincial People's Hospital
state: Guangdonng
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Wu Yilong, PhD
role: PRINCIPAL_INVESTIGATOR
References: