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Active, not recruitingNCT06700421Updated Nov 22, 2024

Phase II Clinical Study of Adebrelimab Combined with Apatinib in the Treatment of Locally Advanced Non-small Cell Lung Cancer Patients with Radiation Pneumonitis

A Phase 2 interventional study of Adebrelimab + Apatinib in Unresectable Locally Advanced Non-small Cell Lung Cancer, sponsored by Wei Zhou. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-22.

Sponsored by Wei Zhou · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as active, not recruiting.
  • Registered 3 months after the study started (first participant enrolled Aug 2024, registered Nov 2024).
Phase
Phase 2
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

A prospective, single-center, phase II clinical study of adebrelimab combined with apatinib in the treatment of unresectable stage III NSCLC patients with grade ≤2 radiation pneumonitis after definitive chemoradiotherapy

Read the detailed description

A prospective, single-center, phase II clinical study of adebrelimab combined with apatinib in the treatment of unresectable stage III NSCLC patients with grade ≤2 radiation pneumonitis after definitive chemoradiotherapy.At least 32 participants will be enrolled in this study.

02

Conditions studied

  • Unresectable Locally Advanced Non-small Cell Lung Cancer

Keywords

  • Unresectable locally advanced non-small cell lung cancer
  • Radiation pneumonitis
  • Adebrelimab
  • Apatinib
  • Chemoradiotherapy
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 32 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Wei Zhou is the lead sponsor of 3 studies on the registry; 1 is 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

  1. Age ≥18 years old, male or female;
  2. ECOG PS score 0-1;
  3. The expected survival time is not less than 12 weeks;
  4. Histologically or cytologically confirmed non-small cell lung cancer patients with unresectable locally advanced (stage III) (AJCC TNM staging, 8th edition);
  5. Patients who are not candidates for EGFR, ALK, or ROS1 targeted therapy, as confirmed by histologic or cytologic specimens (with documented evidence of no EGFR sensitizing mutation, ALK gene rearrangement, or ROS1 gene fusion);
  6. Patients with grade 2 or below radiation pneumonitis without disease progression after receiving platinum-based concurrent/sequential chemoradiotherapy;
  7. First dose was administered on days 1-42 (up to 42 days) after completion of concurrent/sequential platinum-based chemoradiotherapy for grade ≤1 RP; Patients with grade 2 RP who were downgraded to less than grade 1 RP within 56 days (including 56 days) after concurrent/sequential chemoradiotherapy received the first medication, and consolidation chemotherapy after radiotherapy was not allowed during the period.

All toxic effects from previous antineoplastic therapy, except hearing loss, alopecia, and fatigue, had to have recovered to grade 1 or less (according to NCI CTCAE V5.0) or baseline levels to be eligible.

  1. Have not received any anti-CTLA-4, anti-PD-1, anti-PD-L1/2, anti-angiogenesis inhibitors, or anti-tumor vaccine therapy; 10. Provide or collect biopsy tissue or blood samples during the treatment for biomarker analysis according to the subjects' wishes; 11. Normal function of major organs and bone marrow; 12. Female subjects of childbearing potential had to have a negative serum or urine pregnancy test 72 hours before starting the trial and be willing to use a highly effective, medically approved contraceptive method for the duration of the study and for 90 days after the last dose of the trial drug; Male participants whose partner was a woman of childbearing potential agreed to use an effective method of contraception or to be surgically sterilized for the duration of the study and for 90 days after the last dose of the trial drug.
  1. The subjects voluntarily participated in this study, and signed the informed consent form. The compliance was good, and the efficacy and adverse reactions were followed up according to the protocol.

Exclusion criteria

Exclusion Criteria:

  1. Histological types of mixed small cell lung cancer and non-small cell lung cancer;
  2. Disease progression after chemoradiotherapy; Had undergone major surgery within 28 days before the first dose of a study drug or was planned to undergo major surgery during the study (at the investigator's discretion); 3.
  1. Administration of live attenuated vaccine within 28 days prior to dose or planned for the duration of the study; 5. Participated in another clinical study within 28 days before the first use of a trial drug, and used any trial drug; 6. Grade ≥3 radiation pneumonitis caused by chemoradiotherapy; 7. Imaging (CT/MRI) showed that the tumor invaded the large blood vessels or had unclear boundaries with blood vessels; 8. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 9. Presence of any active autoimmune disease or a history of autoimmune disease with expected recurrence; 10. Congenital or acquired immune deficiency; 11. Suffering from an infectious disease that is poorly controlled; 12. Subjects requiring systemic treatment with corticosteroids (>10mg/ day of prednisone or equivalent dose of the same hormone) or other immunosuppressive agents within 14 days before the first dose of the trial drug; 13. Cancer other than NSCLC in the past 5 years; 14. Evidence of past or current severe impairment of lung function, with forced expiratory volume in 1 second (FEV1) \<1.2L or DLCO\<50% of predicted value; 15. Grade II or above myocardial ischemia or myocardial infarction with poorly controlled arrhythmia; 16. Have poorly controlled hypertension; 17. Occurrence of arterial/venous thrombotic events (cerebral embolism, deep vein thrombosis, pulmonary embolism, etc.) within 6 months before the first dose; 18. Subjects with clinically significant bleeding symptoms or clear evidence or history of bleeding tendency within 3 months before the first dose; 19. Obvious hemoptysis symptoms within 30 days before the first dose or hemoptysis of 2.5mL or more per day; 20. Known hereditary or acquired bleeding and thrombophilia (e.g. hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc.); 21. Urine routine showed urine protein ≥ (++), or 24-hour urine protein ≥ 1.0g; 22. The need for systemic antibiotics due to infection within 14 days before the first dose of medication; Or unexplained fever > 38.5 ° C 14 days before the first dose of medication; 23. Pregnant or lactating women; 24. Known allergy or intolerance to the study drug or its excipients; 25. Any condition that the investigator considers may harm the subject or cause the subject to be unable to meet or perform the requirements of the study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • Other
    Group A

    Patients with grade 0-1 radiation pneumonitis were enrolled and treated with adebrelimab combined with apatinib within 42 days after definitive chemoradiotherapy

    Drug: Adebrelimab + Apatinib

  • Other
    Group B

    Patients with grade 2 radiation pneumonitis were enrolled and treated with adebrelimab combined with apatinib within 56 days after definitive chemoradiotherapy

    Drug: Adebrelimab + Apatinib

Interventions

  • DrugAdebrelimab + Apatinib

    Adebrelimab combined with apatinib

    Also known as: immunotherapy, Programmed death ligand 1 inhibitor, Antiangiogenic agents

06

What researchers measure

Primary outcomes

  1. Progression free survival (PFS)

    Refers to the time from the start of nonrandomization until tumor progression or death from any cause, whichever occurs first

    Time frame: Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months

Secondary outcomes

  1. overall survival, OS

    Refers to the time from the start of nonrandomization until death from any cause.

    Time frame: Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months

  2. Objective Response Rate, ORR

    Refers to the proportion of patients who have achieved a pre-defined tumor volume reduction (CR/PR) and maintained the minimum time frame required by the accepted response evaluation criteria (such as solid tumor RECIST Version 1.1).

    Time frame: Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months

  3. Disease control rate, DCR

    Proportion of all subjects whose best overall response (BOR) was rated as complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1 criteria.

    Time frame: Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months

  4. Duration of response, DOR

    Defined as the period from the date the tumor remission was first recorded to the date the disease progression was first recorded or the date of death from any cause

    Time frame: Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months

07

Study locations

1 site
  • Chongqing University Cancer Hospital
    Chongqing, Chongqing, China
08

References and documents

Individual participant data

Plan to share: Yes — The survival data of individual participant will be shared after the research iscompleted.

Supporting information: Study protocol, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06700421
Lead sponsor
Wei Zhou
Responsible party
Wei Zhou (Director of Radiation Oncology Center, Chongqing University Cancer Hospital) — Sponsor-investigator
First posted
Nov 22, 2024
Start date
Aug 13, 2024
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Nov 22, 2024

Study contacts

Wei Zhou
principal investigator · Chongqing University Cancer Hospital

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 active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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