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Not yet recruitingNCT07890636Updated Oct 22, 2026

Adebrelimab Plus Famitinib as Adjuvant Therapy in Non-pCR NSCLC

A Phase 2 interventional study of Adebrelimab and Adjuvant treatment in Lung Neoplasm Malignant, sponsored by Ruijin Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Ruijin Hospital · Phase 2, Interventional, and Treatment

Updated Oct 22, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
64
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Neoadjuvant immunotherapy combined with chemotherapy followed by surgery has become an important treatment strategy for resectable non-small cell lung cancer (NSCLC). However, patients who do not achieve a pathological complete response (non-pCR) after neoadjuvant treatment remain at a high risk of disease recurrence, and optimal postoperative adjuvant treatment for these patients remains unclear. Adebrelimab, an immune checkpoint inhibitor targeting PD-L1, and famitinib, a multitarget tyrosine kinase inhibitor with antiangiogenic activity, may have complementary antitumor effects. Therefore, we conduct this prospective, single-arm, phase II clinical trial to investigate the efficacy and safety of adebrelimab combined with famitinib as postoperative adjuvant therapy in patients with resectable NSCLC who did not achieve pCR after neoadjuvant chemoimmunotherapy followed by surgery.

Read the detailed description

Lung cancer is one of the leading causes of cancer-related deaths worldwide. Neoadjuvant immunotherapy combined with platinum-based chemotherapy followed by surgery has significantly improved treatment outcomes in patients with resectable non-small cell lung cancer (NSCLC). However, patients with residual viable tumor after neoadjuvant treatment (non-pCR) remain at increased risk of postoperative recurrence. Adebrelimab is a monoclonal antibody targeting PD-L1 that enhances antitumor immune responses, while famitinib is a multitarget tyrosine kinase inhibitor with antiangiogenic activity. The combination of immune checkpoint blockade and antiangiogenic therapy may provide additional antitumor benefits. Therefore, we conduct this prospective, open-label, single-arm, multicenter phase II clinical trial to evaluate the efficacy and safety of adebrelimab combined with famitinib as postoperative adjuvant therapy in patients with resectable NSCLC who did not achieve pCR after neoadjuvant chemoimmunotherapy. A total of 64 patients with stage II-IIIB NSCLC (stage IIIB restricted to N2 disease) who have received 2-4 cycles of neoadjuvant adebrelimab plus platinum-based chemotherapy followed by radical surgery will be enrolled. Patients will receive adebrelimab (1200 mg intravenously every 3 weeks) combined with famitinib (20 mg orally once daily). The primary endpoint is the 2-year disease-free survival (DFS) rate. Secondary endpoints include DFS, overall survival (OS), and treatment-related adverse events.

02

Conditions studied

  • Lung Neoplasm Malignant

Keywords

  • Non-small cell lung cancer
  • Immunotherapy
  • Perioperative therapy
03

In context

Lung Neoplasms

7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.

This study's planned enrollment of 64 is close to the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 667 studies on the registry; 376 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients aged 18-75 years, male or female;
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  3. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), initially diagnosed as stage II-IIIB according to the AJCC 9th edition. Stage IIIB disease is restricted to N2 involvement, with non-bulky lymph nodes (short-axis diameter \<2 cm) considered completely resectable by the investigator or multidisciplinary team;
  4. Patients who have received 2-4 cycles of neoadjuvant adebrelimab combined with platinum-based doublet chemotherapy followed by radical surgery, with postoperative pathological confirmation of non-pathological complete response (non-pCR);
  5. No prior anticancer treatment other than the specified neoadjuvant chemoimmunotherapy, including radiotherapy or targeted therapy;
  6. Adequate pulmonary function for curative-intent R0 resection, as assessed by the treating thoracic surgeon;
  7. Adequate organ function, including absolute neutrophil count ≥1.8 × 10⁹/L, hemoglobin ≥100 g/L, platelet count ≥125 × 10⁹/L, total bilirubin ≤1.5 × upper limit of normal (ULN), ALT and AST ≤2.5 × ULN, serum creatinine ≤1.5 × ULN, and creatinine clearance ≥50 mL/min, without blood transfusion, hematopoietic growth factors, or corrective medication within 14 days;
  8. Women of childbearing potential must have a negative pregnancy test within 3 days before the first dose and agree to use effective contraception during treatment and for 180 days after the last dose. Male patients with partners of childbearing potential must also agree to use effective contraception during the same period;
  9. Patients voluntarily participate in the study, provide written informed consent, and agree to comply with the study procedures and follow-up.

Exclusion criteria

Exclusion Criteria:

  1. Patients with known EGFR mutations or ALK alterations;
  2. T4 tumors invading the heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, or carina; T4 tumors with separate tumor nodules in different ipsilateral lobes; or superior sulcus (Pancoast) tumors;
  3. Patients who have received systemic immunosuppressive medications within 4 weeks before the first dose of study treatment, except intranasal or inhaled corticosteroids or physiological doses of systemic corticosteroids (≤10 mg/day prednisone equivalent), discontinued for at least 1 week;
  4. History of malignancy other than NSCLC within the past 5 years;
  5. Receipt of a live attenuated vaccine within 4 weeks before the first dose or planned vaccination during the study;
  6. Current participation in another interventional clinical trial or receipt of investigational drugs or devices within 4 weeks before the first dose, or failure to recover from previous treatment-related toxicities to grade ≤1 or baseline, except fatigue or alopecia;
  7. Severe infection requiring intravenous antibiotics, antifungal, or antiviral treatment within 4 weeks before the first dose, or unexplained fever >38.5°C during screening;
  8. History of or suspected pneumonitis, interstitial lung disease, or other pulmonary conditions that may interfere with pulmonary function assessment;
  9. Active autoimmune disease or history of autoimmune disease. Patients with hypothyroidism controlled by hormone replacement therapy, vitiligo, or resolved childhood asthma requiring no treatment in adulthood may be eligible. Patients requiring bronchodilator treatment are excluded;
  10. Known congenital or acquired immunodeficiency, including HIV infection, active hepatitis B, hepatitis C, HBV/HCV coinfection, or alcoholic cirrhosis;
  11. Significant cardiovascular disease, including myocardial ischemia or infarction, uncontrolled arrhythmia (QTc ≥450 ms in males or ≥470 ms in females), heart failure of NYHA class II or higher, left ventricular ejection fraction \<50%, myocardial infarction within 6 months, uncontrolled angina, clinically significant pericardial disease, or active ischemic or conduction abnormalities;
  12. Creatine kinase (CK) >3 × ULN, history of severe bleeding events, or arterial or venous thromboembolic events;
  13. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
  14. Known allergy, hypersensitivity, or intolerance to the study drugs or their components;
  15. Patients with known psychiatric disorders or substance abuse that may interfere with study participation;
  16. Any underlying medical condition that, in the investigator's opinion, may compromise patient safety or prevent compliance with study requirements.
05

Study design

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

Study arms

  • Experimental
    Adjuvant Treatment

    Participants who have received 2-4 cycles of neoadjuvant adebrelimab combined with platinum-based chemotherapy followed by radical surgery without achieving a pathological complete response (non-pCR) will receive postoperative adjuvant treatment with adebrelimab (1200 mg, IV) every 3 weeks (Q3W) and famitinib (20 mg, orally) once daily. Treatment will continue for up to 16 cycles or until disease recurrence, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria.

    Drug: Adebrelimab · Drug: Adjuvant treatment

Interventions

  • Adebrelimab 1200 mg, administered intravenously every 3 weeks (Q3W) for up to 16 cycles as postoperative adjuvant treatment.

  • DrugAdjuvant treatment

    Famitinib 20 mg, administered orally once daily in 21-day cycles as postoperative adjuvant treatment. Dose reduction to 15 mg is permitted in patients experiencing treatment-related toxicity.

06

What researchers measure

Primary outcomes

  1. 2-Year Disease-Free Survival (DFS) Rate

    The 2-year DFS rate is defined as the probability of patients remaining alive without disease recurrence or metastasis at 2 years from the first dose of postoperative adjuvant treatment with adebrelimab and famitinib.

    Time frame: Up to 2 years from the first dose of study treatment.

Secondary outcomes

  1. Disease-Free Survival (DFS)

    DFS is defined as the time from the first dose of postoperative adjuvant treatment to the first documented disease recurrence, metastasis, or death from any cause, whichever occurs first.

    Time frame: From the first dose of study treatment, assessed up to 3 years.

  2. Overall Survival (OS)

    OS is defined as the time from the first dose of postoperative adjuvant treatment to death from any cause. Patients who are alive at the last follow-up will be censored at the date they were last known to be alive.

    Time frame: From the first dose of study treatment, assessed up to 3 years.

  3. Safety

    The incidence and severity of treatment-related adverse events (TRAEs), serious adverse events (SAEs), and clinically significant laboratory abnormalities will be assessed. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.

    Time frame: From informed consent to 30 days after the last dose for AEs, and up to 90 days after the last dose for SAEs/AESIs.

07

Study locations

1 site
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, 200025, China
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07890636
Lead sponsor
Ruijin Hospital
Collaborators
Guangdong Provincial People's Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Fujian Medical University Union Hospital, Tang-Du Hospital
Responsible party
Hecheng Li M.D., Ph.D (Professor, Ruijin Hospital) — Principal investigator
First posted
Oct 22, 2026
Start date
Oct 20, 2026 (estimated)
Primary completion
Dec 1, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Oct 22, 2026

Study contacts

Hecheng Li, MD, PhD
Contact
lihecheng2000@hotmail.com
0086-021-64370045
Yichao Han, MD, PhD
Contact
trey_e@foxmail.com
0086-15021126517
Hecheng Li, MD, PhD
study chair · Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Runsen Jin, MD, PhD
study director · Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Yichao Han, MD, PhD
principal investigator · Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Jingyuan Fan, MD, PhD
principal investigator · Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

Oversight

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

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