This phase II trial tests how well zipalertinib with carboplatin and pemetrexed works in treating stage II-IIIB non small cell lung cancer. that can be removed by surgery (resectable). Zipalertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make DNA and may kill tumor cells. Giving zipalertinib with carboplatin and pemetrexed may kill more tumor cells in patients with resectable, stage II-IIIB non-small cell lung cancer.
Participant has provided informed consent prior to initiation of any study specific activities/procedures
Male or female ≥ 18 years of age at time of enrollment and willing and able to provide informed consent
Histologically confirmed non-squamous NSCLC performed within 90 days of enrollment with EGFR Ex20Ins-mutated (addition of 1 or more amino acids) or uncommon/compound EGFR mutations (E709X, G719X, L747X, S758I, and/or L861Q) in tumor tissue or blood; any one of these mutations would qualify if compounded with another EGFR mutation
Staging positron emission tomography-computed tomography (PET-CT) and brain magnetic resonance imaging (MRI) within 60 days of enrollment demonstrating stage II, IIIA, or IIIB (N2) NSCLC (American Joint Commission for Cancer [AJCC] version [v] 9); mediastinal staging is required by bronchoscopy or mediastinoscopy
Concurrent enrollment in another therapeutic clinical study, unless enrolled only in the follow-up period or an observational study. Use of any antineoplastic therapy must not have been received within 30 days prior to the treatment initiation
Treatment with live virus, including live-attenuated vaccination, within 30 days prior to the first dose of study treatment. Treatment with inactive vaccines (e.g., non-live or non-replicating agent) and live viral non-replicating vaccines within 3 days prior to first dose of study treatment
History of active primary immunodeficiency
Mixed small cell and NSCLC histology
Single group
Biospecimen Collection
Procedure/SurgeryUndergo blood and urine sample collection
Carboplatin
DrugGiven IV
Computed Tomography
Procedure/SurgeryUndergo CT scan
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Pemetrexed
DrugGiven IV
Positron Emission Tomography
Procedure/SurgeryUndergo PET scan
Zipalertinib
DrugGiven PO
Major pathologic response
Defined as ≤10% viable tumor present histologically in the resected tumor specimen after neoadjuvant treatment. A 95% confidence interval for the MPR rate will be calculated using the Clopper-Pearson (exact binomial) method.
Overall response rate (ORR)
Defined as complete response or partial response by Response Evaluation Criteria in Solid Tumors 1.1 criteria. ORR estimate and its associated 95% confidence interval will be calculated. Will compute the proportion of participants achieving complete response (CR) or partial response (PR) and compute 95% confidence intervals using the exact (Clopper-Pearson) confidence intervals.
Pathologic complete response
Defined as no viable tumor present histologically in the resected tumor specimen. Will compute the proportion of participants achieving CR or PR and compute 95% confidence intervals using the exact (Clopper-Pearson) confidence intervals.
Event free survival (EFS)
Will be analyzed using the Kaplan-Meier method. Median EFS and corresponding 95% confidence intervals will be reported.
Nodal downstaging
Defined as having N2 or N1 disease prior to the initiation of neoadjuvant treatment with subsequent nodal downstaging to N1 or N0 disease at time or surgery. Will be reported as a percentage of participants who achieve histological downstaging at time of surgery.
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Jonsson Comprehensive Cancer Center
Lead sponsor
Taiho Oncology, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
