Health Trials

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 group

Locations

3
Peking Union Medical College Hospital Beijing China
The First Affiliated Hospital of Guangzhou Medical University Guangzhou China
The First Affiliated Hospital of Zhejiang University School of Medicine Zhejiang China

Sponsors 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