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

Biotheus

Status and phase: Active, not recruiting; Phase 2

Conditions: NSCLC

Treatments: Drug: Pemetrexed; Drug: Carboplatin; Drug: PM8002

Study type: Interventional

Funder types: Industry

Identifiers

NCT05756972

PM8002-BC010C-NSCLC-R

Details and patient eligibility

About

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.

Full description

This study is a phase II, single-arm study, 64 participants were enrolled as of 6 Feb 2024, and recruitment was completed.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

PM8002+Chemotherapy

Experimental group

Description:

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.

Treatment:

Drug: PM8002

Drug: Carboplatin

Drug: Pemetrexed