Adibelimab, Famitinib and Chemotherapy for Advanced NSCLC After PD-1 Inhibitor Failure

Non Small Cell Lung Cancer Clinical Trial

Official title:

Exploratory Study of Adibelimab Combined With Famitinib and Chemotherapy for the Treatment of Patients With Driver Gene-Negative Locally Advanced or Metastatic NSCLC Progressing After PD-1 Monoclonal Antibody Combined With Chemotherapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06336954
• Other study ID #: MA-NSCLC-#-037
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 30, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: Second Affiliated Hospital of Xi'an Jiaotong University
• Contact: Hui Guo, Doctor
• Phone: 13572824106
• Email: guohui[@]xjtufh.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective, single-arm trial explores the efficacy of Adibelimab monoclonal antibody combined with Famitinib and chemotherapy in treating locally advanced or metastatic NSCLC patients with negative driver genes who have progressed after PD-1 monoclonal antibody and chemotherapy treatment. The study focuses on assessing progression-free survival (PFS) in 40 participants. Key objectives include evaluating PFS and understanding the progression patterns post-first-line immunotherapy, with an interest in whether switching from PD-1 to PD-L1 inhibitors can overcome immune resistance.

Description:

This study is a prospective, single-arm clinical investigation. It aims to assess the effectiveness of the Adibelimab monoclonal antibody in combination with Famitinib and chemotherapy for treating patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) without driver mutations, who have progressed following initial treatment with PD-1 monoclonal antibodies and chemotherapy. The study's primary focus is on evaluating progression-free survival (PFS) among the 40 participants, spanning from December 2023 to December 2026. It intends to explore the therapeutic potential of switching from PD-1 to PD-L1 inhibitors in overcoming immune resistance and identify subgroups that may particularly benefit from this treatment strategy, thereby providing insights into personalized therapy for advanced NSCLC.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2026
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must be adults (=18 years) who have signed an informed consent form.
• They should have an ECOG performance status of 0-1. Diagnosed with stage IIIB-IV NSCLC and have progressed after PD-1 inhibitor treatment.
• Expected to live at least 3 months and have at least one measurable lesion per RECIST v1.1.
• Laboratory test results must meet specific criteria for blood counts, liver and kidney function, and coagulation parameters.
• Patients with stable, treated brain metastases are eligible.
• Women of childbearing potential and men with partners of childbearing potential must agree to use contraception.

Exclusion Criteria:

• Prior therapy with anti-PD-L1, anti-PD-L2, other immune checkpoint inhibitors, or specific cancer treatments.
• Certain cancer types, known mutations, or recent use of systemic corticosteroids or immunosuppressive medications.
• Active brain or leptomeningeal metastases without stability post-treatment, recent severe infections, or major surgery.
• Other conditions that might interfere with the study, such as uncontrollable third-space fluid accumulations, active autoimmune diseases or infections, significant bleeding or thromboembolic events, serious heart conditions, severe allergies to study drugs, other active malignancies, HIV/AIDS, hepatitis B or C infection, or participation in another interventional clinical study within a specified period.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Drug:
• Adibelimab
Adibelimab (1200mg, IV, every 3 weeks) combined with Famitinib (20mg, daily, orally) and Albumin-bound Paclitaxel (260mg/m2, Day 1, every 3 weeks)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival time (PFS)	the time from the start of the first dose of medication to the first occurrence of disease progression (as confirmed by the researcher according to RECIST v1.1 standards) or death from any cause, whichever occurs first.	4 months
Secondary	Objective Response Rate	Objective Response Rate	4 months
Secondary	Duration of Response	Duration of Response	4 months
Secondary	Overall Survival	Overall Survival	4 months
Secondary	Treatment-Related Adverse Events	Incidence rates of Treatment-Related Adverse Events, Serious Adverse Events and Treatment-Emergent Adverse Events	4 months