NCT06336954Not yet recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 29 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 19 Mar 2024
- Start date
- 30 Mar 2024
- Primary completion date
- 31 Jul 2024
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Diseases
- Lung cancer
- NCT number
- NCT06336954
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 30 Mar 2024 to the primary completion date, 31 Jul 2024
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior therapy with anti-PD-L1, anti-PD-L2, other immune checkpoint inhibitors, or specific cancer treatments.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.