Fulzerasib Sequential Sintilimab Plus Platinum-Doublet Neoadjuvant Therapy for Resectable KRAS G12C-Mutant NSCLC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJianxing He
About this trial
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.
Eligibility criteria
Qualifiers
Sign the Informed Consent Form (ICF) and be able to comply with the visit and related procedures as stipulated in the protocol.
Be male or female, aged ≥18 years old.
Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC).
Clinical stage IB to IIIA disease, according to the 8th edition of the TNM classification for lung cancer as defined by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC).
Disqualifiers
Histological or cytological pathology confirms the presence of small cell carcinoma, neuroendocrine carcinoma, sarcoma, lymphoepithelioma-like carcinoma, salivary gland tumors, or mesenchymal tumor components.
Tumor invasion of the diaphragm, mediastinum, heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, or carina.
Superior sulcus (Pancoast) tumor.
Presence of tumor nodules in the contralateral lung lobe. Biopsy is required to confirm if contralateral lung nodules are clinically suspected.
Trial design
Treatments tested in this trial
- fulzerasib
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Jianxing He
Lead sponsor
The First Affiliated Hospital of Guangzhou Medical University
Sponsor institution
Innovent Biologics (Suzhou) Co. Ltd.
Collaborator
Source ClinicalTrials.gov