Lung Neoplasm MalignantPhase 2NCT07890636
Adebrelimab Plus Famitinib as Adjuvant Therapy in Non-pCR NSCLC
A Phase 2 study testing Adebrelimab and Adjuvant treatment in people with Lung Neoplasm Malignant, run by Ruijin Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Neoplasm Malignant
- What is being tested?
- Adebrelimab and Adjuvant treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2026to 31 Dec 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-75 years, male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- 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;
- 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);
- No prior anticancer treatment other than the specified neoadjuvant chemoimmunotherapy, including radiotherapy or targeted therapy;
- Adequate pulmonary function for curative-intent R0 resection, as assessed by the treating thoracic surgeon;
Show all 9Show fewer
- 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;
- 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;
- Patients voluntarily participate in the study, provide written informed consent, and agree to comply with the study procedures and follow-up.
Who cannot join
- Patients with known EGFR mutations or ALK alterations;
- 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;
- 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;
- History of malignancy other than NSCLC within the past 5 years;
- Receipt of a live attenuated vaccine within 4 weeks before the first dose or planned vaccination during the study;
- 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;
Show all 16Show fewer
- Severe infection requiring intravenous antibiotics, antifungal, or antiviral treatment within 4 weeks before the first dose, or unexplained fever >38.5°C during screening;
- History of or suspected pneumonitis, interstitial lung disease, or other pulmonary conditions that may interfere with pulmonary function assessment;
- 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;
- Known congenital or acquired immunodeficiency, including HIV infection, active hepatitis B, hepatitis C, HBV/HCV coinfection, or alcoholic cirrhosis;
- 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;
- Creatine kinase (CK) >3 × ULN, history of severe bleeding events, or arterial or venous thromboembolic events;
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Known allergy, hypersensitivity, or intolerance to the study drugs or their components;
- Patients with known psychiatric disorders or substance abuse that may interfere with study participation;
- Any underlying medical condition that, in the investigator's opinion, may compromise patient safety or prevent compliance with study requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200025
Hecheng Li, MD, PhD, 0086-021-64370045, lihecheng2000@hotmail.com
Yichao Han, MD, PhD, 0086-15021126517, trey_e@foxmail.com
About this study
Official title: A Prospective, Single-Arm, Phase II Study of the Efficacy and Safety of Adebrelimab in Combination With Famitinib as Postoperative Adjuvant Therapy for NSCLC Patients Who Did Not Achieve Pathological Complete Response
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.
- Conditions
- Lung Neoplasm Malignant
- Being tested
- Adebrelimab, Adjuvant treatment
- Keywords
- Non-small cell lung cancer, Immunotherapy, Perioperative therapy
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
Adebrelimab 1200 mg, administered intravenously every 3 weeks (Q3W) for up to 16 cycles as postoperative adjuvant treatment.
Adjuvant treatmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant Treatment | Experimental | 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. Receives: Drug: Adebrelimab; Drug: Adjuvant treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years from the first dose of study treatment.
Secondary outcomes (3)
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.
Measured: From the first dose of study treatment, assessed up to 3 years.
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.
Measured: From the first dose of study treatment, assessed up to 3 years.
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.
Measured: From informed consent to 30 days after the last dose for AEs, and up to 90 days after the last dose for SAEs/AESIs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion1 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Neoplasm MalignantStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Fujian Medical University Union Hospital, Tang-Du Hospital
- Responsible party
- Principal investigator, Hecheng Li M.D., Ph.D, Ruijin Hospital
- Investigators
- Hecheng Li, MD, PhD, Study chair, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaRunsen Jin, MD, PhD, Study director, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaYichao Han, MD, PhD, Principal investigator, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaJingyuan Fan, MD, PhD, Principal investigator, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890636
- Sponsor's protocol ID
- RTS-031
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No