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

NCT ID: NCT05756972

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-26
• Study Completion Date: 2025-12-31

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.

Conditions

NSCLC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PM8002+Chemotherapy

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.

Group Type: EXPERIMENTAL

PM8002

Intervention Type: DRUG

IV infusion

Carboplatin

Intervention Type: DRUG

IV infusion

Pemetrexed

Intervention Type: DRUG

IV infusion

Interventions

PM8002

IV infusion

Intervention Type: DRUG

Carboplatin

IV infusion

Intervention Type: DRUG

Pemetrexed

IV infusion

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotheus Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wu Yilong, PhD

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial People's Hospital

Locations

Medical Ethics Committee of Guangdong Provincial People's Hospital

Guangzhou, Guangdonng, China

Countries

China

Other Identifiers

PM8002-BC010C-NSCLC-R

Identifier Type: -

Identifier Source: org_study_id