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

NCT06336954 | Not Yet Recruiting Phase 2

• 1 other identifier: MA-NSCLC-#-037
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Objective Response Rate

  4 months

• Duration of Response

  4 months

• Overall Survival

  4 months

• Treatment-Related Adverse Events

  4 months

Study Arms (1)

experimental group

EXPERIMENTAL

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

Drug: Adibelimab

Interventions

Adibelimab DRUG

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

Also known as: Famitinib, Chemotherapy

experimental group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

famitinib; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Hui Guo

  Second Affiliated Hospital of Xian Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Guo, Doctor

CONTACT

13572824106; guohui@xjtufh.edu.cn

Study Design

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

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 29, 2024
• Study Start: March 30, 2024
• Primary Completion: July 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 29, 2024

Record last verified: 2024-03