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

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

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.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
Adibelimab (1200mg, IV, every 3 weeks) combined with Famitinib (20mg, daily, orally) and Albumin-bound Paclitaxel (260mg/m2, Day 1, every 3 weeks).
Adibelimab (1200mg, IV, every 3 weeks) combined with Famitinib (20mg, daily, orally) and Albumin-bound Paclitaxel (260mg/m2, Day 1, every 3 weeks)
Other Names:
  • Chemotherapy
  • Famitinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival time (PFS)
Time Frame: 4 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: 4 months
Objective Response Rate
4 months
Duration of Response
Time Frame: 4 months
Duration of Response
4 months
Overall Survival
Time Frame: 4 months
Overall Survival
4 months
Treatment-Related Adverse Events
Time Frame: 4 months
Incidence rates of Treatment-Related Adverse Events, Serious Adverse Events and Treatment-Emergent Adverse Events
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hui Guo, Second Affiliated Hospital of Xian Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2024

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

March 27, 2024

First Posted (Estimated)

March 29, 2024

Study Record Updates

Last Update Posted (Estimated)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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