A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With NSCLC

NCT05756972 | Active Not Recruiting Phase 2

• 1 other identifier: PM8002-BC010C-NSCLC-R
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Objective response rate is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.

  Up to approximately 2 years

Secondary Outcomes (9)

• Progression free survival (PFS)

  Up to approximately 2 years

• Overall survival (OS)

  Up to approximately 2 years

• Disease control rate (DCR)

  Up to approximately 2 years

• Duration of response (DoR)

  Up to approximately 2 years

• Time to response (TTR)

  Up to approximately 2 years

Other Outcomes (3)

• Population PK analysis

  Up to 30 days after last treatment

• Correlation between PM8002 exposure, immunogenicity and efficacy

  Up to approximately 2 years

• Correlation between PM8002 exposure, immunogenicity and safety

  Up to 30 days after last treatment

Study Arms (1)

PM8002+Chemotherapy

EXPERIMENTAL

Subjects will be administered with PM8002 plus pemetrexed and carboplatin via intravenously (IV) Q3W for 4 cycles, followed by PM8002 and pemetrexed until progression or for a maximum of 2 years.

Drug: PM8002; Drug: Carboplatin; Drug: Pemetrexed

Interventions

PM8002 DRUG

IV infusion

PM8002+Chemotherapy

Carboplatin DRUG

IV infusion

PM8002+Chemotherapy

Pemetrexed DRUG

IV infusion

PM8002+Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form before any trial-related processes.
• Age ≥ 18 years male or female.
• 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).
• with EGFR mutation confirmed by tumor histology or cytology or hematology prior to EGFR-TKI treatment.
• EGFR-TKI resistance, confirmed by RECIST v1.1.
• have adequate organ function.
• 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.
• The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1.

You may not qualify if:

• Have other driving gene mutations that can obtain effective treatment.
• Have previously received systemic anti-tumor treatment other than EGFR-TKI for advanced non-squamous NSCLC.
• Have received systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of study drugs.
• Have received EGFR-TKI treatment, within 14 days prior to the first dose of study drugs
• Anticoagulant or thrombolytic agent within 10 days prior to the first dose of study drugs.
• Evidence and history of severe bleeding tendency or coagulation dysfunction.
• The toxicity of previous anti-tumor therapy has not been alleviated.
• Symptomatic central nervous system metastases (CNS) metastasis and/or cancerous meningitis.
• Have suffered from the second primary active malignant tumor in the past 5 years.

Sponsors & Collaborators

• Biotheus Inc.: lead

Study Sites (1)

Medical Ethics Committee of Guangdong Provincial People's Hospital

Guangzhou, Guangdonng, 519041, China

Location

MeSH Terms

Interventions

Carboplatin; Pemetrexed

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Wu Yilong, PhD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 7, 2023
• Study Start: June 26, 2023
• Primary Completion: September 13, 2024
• Study Completion: December 1, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: After the trial completed
• Access Criteria: NCI is committed to sharing data in accordance with NIH policy.

Locations

CN (1)