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New treatment option for Resectable NSCLC
Official title Fulzerasib Sequential Sintilimab Plus Platinum-Doublet Neoadjuvant Therapy for Resectable KRAS G12C-Mutant NSCLC
ClinicalTrials.gov ID: NCT07492342
What this study is testing
What is fulzerasib?
fulzerasib is an investigational medicine, being studied as a potential treatment for resectable nsclc.
Also referred to as sintilimab, Platinum-Doublet.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- All people must have a written test report before enrollment to prove the presence of KRAS G12C mutation; and must have no sensitive mutations of...
You likely can't join if
- Histological or cytological pathology confirms the presence of small cell carcinoma, neuroendocrine carcinoma, sarcoma, lymphoepithelioma-like...
- 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.
- Documented brain metastasis. Patients with suspected brain metastasis must undergo brain imaging for further confirmation.
- Have significant cardiovascular or cerebrovascular diseases, such as: 1)Experienced definite cardiovascular abnormal events within 6 months, such as...
See the full eligibility criteria
- 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...
- All people must have a written test report before enrollment to prove the presence of KRAS G12C mutation; and must have no sensitive mutations of Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK).
- The patient is deemed by a thoracic surgeon to be a candidate for curative resection (R0 resection) and has adequate pulmonary function to undergo the planned pulmonary resection.
- Have at least one measurable lesion according to RECIST 1.1 criteria.
- Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
- Have not received any systemic anti-tumor treatment for locally advanced or metastatic NSCLC before.
- Have adequate organ and bone marrow function (people who have received any cell or growth factor therapy within 2 weeks before the first administration of the study drug should be excluded), defined as follows: 1) Blood...
- 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.
- Documented brain metastasis. Patients with suspected brain metastasis must undergo brain imaging for further confirmation.
- Have significant cardiovascular or cerebrovascular diseases, such as: 1)Experienced definite cardiovascular abnormal events within 6 months, such as myocardial infarction, angina pectoris, heart failure, severe...
- Active infections requiring systemic treatment;
- Positive human immunodeficiency virus antibody (HIV-Ab) at baseline;
- Active hepatitis B virus (HBV) infection (positive HBsAg and positive HBV-DNA). For patients with negative HBsAg and positive HBcAb, HBV-DNA testing is required; patients with positive HBV-DNA are excluded;
- Active hepatitis C virus (HCV) infection (positive HCV-Ab and positive HCV-RNA);
- Active pulmonary tuberculosis,, receiving anti-tuberculosis therapy, or having received anti-tuberculosis therapy within 1 year prior to the first dose of study treatment
- Active syphilis. 21.History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 22.Diagnosis of another malignancy within 5 years prior to the first dose,except for radically...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Guangzhou, China
- Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Guangzhou, China; Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.