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Not yet recruitingNCT06336954Updated Mar 29, 2024

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

A Phase 2 interventional study of Adibelimab in Non Small Cell Lung Cancer, sponsored by Second Affiliated Hospital of Xi'an Jiaotong University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-29.

Sponsored by Second Affiliated Hospital of Xi'an Jiaotong University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Non Small Cell Lung Cancer
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In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 40 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Second Affiliated Hospital of Xi'an Jiaotong University is the lead sponsor of 68 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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).

    Drug: Adibelimab

Interventions

  • DrugAdibelimab

    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

06

What researchers measure

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.

    Time frame: 4 months

Secondary outcomes

  1. Objective Response Rate

    Objective Response Rate

    Time frame: 4 months

  2. Duration of Response

    Duration of Response

    Time frame: 4 months

  3. Overall Survival

    Overall Survival

    Time frame: 4 months

  4. Treatment-Related Adverse Events

    Incidence rates of Treatment-Related Adverse Events, Serious Adverse Events and Treatment-Emergent Adverse Events

    Time frame: 4 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06336954
Lead sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
Responsible party
Sponsor
First posted
Mar 29, 2024
Start date
Mar 30, 2024 (estimated)
Primary completion
Jul 31, 2024 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 29, 2024

Study contacts

Hui Guo, Doctor
Contact
guohui@xjtufh.edu.cn
13572824106
Hui Guo
principal investigator · Second Affiliated Hospital of Xian Jiaotong University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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