Actively Recruiting
Fulzerasib Sequential Sintilimab Plus Platinum-Doublet Neoadjuvant Therapy for Resectable KRAS G12C-Mutant NSCLC
Led by Jianxing He · Updated on 2026-03-25
30
Participants Needed
3
Research Sites
100 weeks
Total Duration
On this page
Sponsors
J
Jianxing He
Lead Sponsor
I
Innovent Biologics (Suzhou) Co. Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an exploratory study evaluating the efficacy and safety of neoadjuvant therapy with fulzerasib sequentially combined with sintilimab plus platinum-doublet chemotherapy in patients with resectable non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation. Approximately 30 treatment-naïve patients with stage IB-IIIA (AJCC 8th edition) NSCLC and confirmed KRAS G12C mutation will be enrolled. Eligible subjects will receive 6 weeks of fulzerasib followed by a 2-week washout period, then 3 cycles (q3w) of sintilimab plus investigator's choice of platinum-doublet chemotherapy. An end-of-treatment visit will be performed within 7 days after the last dose of neoadjuvant therapy.
CONDITIONS
Official Title
Fulzerasib Sequential Sintilimab Plus Platinum-Doublet Neoadjuvant Therapy for Resectable KRAS G12C-Mutant NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to follow study procedures
- Male or female aged 18 years or older
- Confirmed diagnosis of primary non-small cell lung cancer (NSCLC)
- Clinical stage IB to IIIA NSCLC by AJCC 8th edition
- Confirmed KRAS G12C mutation and no sensitive EGFR or ALK mutations
- Candidate for curative lung surgery with adequate lung function
- At least one measurable tumor lesion per RECIST 1.1
- ECOG performance status of 0 or 1
- No prior systemic anti-tumor treatment for locally advanced or metastatic NSCLC
- Adequate organ and bone marrow function as defined by blood counts, liver and kidney tests
- Use of effective contraception during treatment and for 180 days after
- Negative pregnancy test for women of childbearing age or postmenopausal status
You will not qualify if you...
- Presence of small cell carcinoma, neuroendocrine carcinoma, sarcoma, or other specified tumor types
- Tumor invading diaphragm, mediastinum, heart, great vessels, trachea, esophagus, or vertebral body
- Superior sulcus (Pancoast) tumor
- Tumor nodules in the opposite lung lobe
- Brain metastases confirmed by imaging
- Significant cardiovascular or cerebrovascular disease within 6 months
- Clinically significant QT interval prolongation
- Active gastrointestinal disease causing diarrhea
- Recent use of strong CYP3A4 or P-gp inhibitors/inducers or certain traditional medicines
- Recent use of proton pump inhibitors or H2 receptor antagonists
- Recent use of immunomodulatory agents or Chinese herbal anti-tumor therapies
- Participation in another interventional clinical trial
- Recent live attenuated vaccine use
- Need for long-term systemic corticosteroids or immunosuppressants
- Major surgery within 4 weeks or non-healing wounds
- History or active lung inflammatory diseases such as pneumonitis or pulmonary fibrosis
- Known allergies to study treatments
- Primary immunodeficiency or active autoimmune/inflammatory diseases
- Active infections including HIV, hepatitis B or C, tuberculosis, or syphilis
- History of organ transplantation
- Other cancers within 5 years except certain treated skin, prostate, or thyroid cancers
- Uncontrolled serious infections, heart failure, arrhythmias, hypertension, or metabolic disorders
- High risk of bleeding or recent thromboembolism
- Significant malnutrition or need for intravenous nutrition
- Intraluminal esophageal or tracheal stents
- Neurological, psychiatric, or social conditions impairing study compliance
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Peking Union Medical College Hospital
Beijing, China
Not Yet Recruiting
2
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Actively Recruiting
3
The First Affiliated Hospital of Zhejiang University School of Medicine
Zhejiang, China
Not Yet Recruiting
Research Team
W
WENHUA LIANG, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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