Trials Sponsors Conditions Drugs Pricing

Conditions

Lung Neoplasm Malignant

Keywords

Non-small cell lung cancerImmunotherapyPerioperative therapy

Outcome Measures

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

Secondary Outcomes (3)

Disease-Free Survival (DFS)
From the first dose of study treatment, assessed up to 3 years.
Overall Survival (OS)
From the first dose of study treatment, assessed up to 3 years.
Safety
From informed consent to 30 days after the last dose for AEs, and up to 90 days after the last dose for SAEs/AESIs.

Study Arms (1)

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.

Drug: AdebrelimabDrug: Adjuvant treatment

Interventions

AdebrelimabDrug

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

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.

Adjuvant Treatment

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients aged 18-75 years, male or female;
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;

Sponsors & Collaborators

Tang-Du Hospital
Othercollaborator
Fujian Medical University Union Hospital
Othercollaborator
Guangdong Provincial People's Hospital

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200025, China

Hecheng Li, MD, PhDCONTACT0086-021-64370045 lihecheng2000@hotmail.com

Yichao Han, MD, PhDCONTACT0086-15021126517 trey_e@foxmail.com

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

Hecheng Li, MD, PhD
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
STUDY CHAIR
Runsen Jin, MD, PhD
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
STUDY DIRECTOR
Yichao Han, MD, PhD
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
PRINCIPAL INVESTIGATOR
Jingyuan Fan, MD, PhD
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
PRINCIPAL INVESTIGATOR

Central Study Contacts

Hecheng Li, MD, PhD

CONTACT

0086-021-64370045 lihecheng2000@hotmail.com

Yichao Han, MD, PhD

CONTACT

0086-15021126517

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

October 16, 2026

First Posted

October 22, 2026

Study Start

October 20, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

December 1, 2029

You may not qualify if:

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;
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;
+1 more criteria

Adebrelimab Plus Famitinib as Adjuvant Therapy in Non-pCR NSCLC

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Adjuvant Treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Adjuvant Treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations