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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
fulzerasib
DrugEligible subjects will receive 6 weeks of furzerasib followed by a 2-week washout period, then 3 cycles (q3w) of sintilimab plus investigator's choice of platinum-doublet chemotherapy.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: fulzerasib+sintilimab+platinum-doubletExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pathological Complete Response, pCR
The proportion of patients with no residual invasive tumor in the primary tumor and all sampled lymph nodes, as assessed by histopathological examination of the resected surgical specimen.
Time frame
At the time of definitive surgerySecondary outcomes
1
Major Pathological Response, MPR
The proportion of patients with ≤10% residual viable tumor cells in the primary tumor, as assessed by histopathological examination of the resected surgical specimen.
Time frame
At the time of definitive surgery2
Objective Response Rate, ORR
The proportion of patients achieving a complete or partial response according to RECIST v1.1, as assessed by the investigator.
Time frame
Every 6 weeks during neoadjuvant treatment, up to the time of surgery3
Complete resection rate (R0 resection)
The proportion of patients who achieve a complete (R0) resection of all known disease, as determined by the surgeon and pathologist at the time of definitive surgical resection.
Time frame
At the time of definitive surgery4
2-year Event-Free Survival (EFS) rate
The proportion of patients alive and free from disease recurrence, progression, or death from any cause at 2 years after study enrollment. Event-free survival will be estimated using the Kaplan-Meier method.
Time frame
From the date of study enrollment until 2 years post-enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jianxing He
Lead sponsor
The First Affiliated Hospital of Guangzhou Medical University
Sponsor institution
Innovent Biologics (Suzhou) Co. Ltd.
Collaborator
Source ClinicalTrials.gov