Zipalertinib with Chemotherapy for Resectable Lung Cancer
This study is testing a new treatment combination for people with stage II-IIIB non-small cell lung cancer that can be removed by surgery. The treatment involves zipalertinib, carboplatin, and pemetrexed. Zipalertinib may work by blocking enzymes that help cancer cells grow. Carboplatin and pemetrexed are chemotherapy drugs that aim to kill or slow the growth of cancer cells. To join, you must be at least 18 years old and have a specific type of non-small cell lung cancer with an EGFR Ex20Ins mutation. The main goal is to see how well this treatment shrinks the tumor before surgery. This study plans to enroll 16 participants, and its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It is a phase II trial, which typically evaluates the effectiveness and safety of a new treatment in a larger group of people.
- What's involved
- You would provide informed consent, undergo blood and urine sample collections, and have CT scans and MRIs. The treatment involves taking zipalertinib by mouth twice daily and receiving carboplatin and pemetrexed intravenously (into a vein) every 21 days for 4 cycles, followed by surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome, major pathologic response, is measured at the time of surgery. The record does not specify how long participants are followed after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07229339
Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer
Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatmentJonsson Comprehensive Cancer CenterInvestigator-initiated
~16 participants
Updated 2026-02-05 on ClinicalTrials.gov
What's tested:Biospecimen CollectionCarboplatinComputed TomographyMagnetic Resonance ImagingPemetrexedPositron Emission Tomography
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Major pathologic response
Measured over At time of surgery
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Arjan Gower, MD · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
No prior systemic treatment for lung cancer
Resectable and operable as determined by thoracic surgeon
At least one measurable lesion according to Response Evaluation Criteira in Solid Tumors (RECIST) 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Absolute neutrophil count (ANC) ≥ 1.0 x 10\^9/L
Platelets ≥ 100 x 10\^9/L
Hemoglobin ≥ 9 g/dL without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)
Glomerular filtration rate (GFR; by Cockroft-Gault or equivalent estimation) ≥ 45 mL/min/1.73 m\^2
Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels \> 1.5 ULN with the exception of participants with Gilbert's disease
Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x ULN
International normalized ratio (INR) or prothrombin time (PT), and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy, as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Able to comply with study requirements
Female participants may not be pregnant or breastfeeding from initial study visit through a minimum of 1 month after last dose of zipalertinib or 6 months after last dose of chemotherapy, whichever is later
Adequate pulmonary function as defined by no requirement for oxygen supplementation
Exclusion
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
Stages I, IIIB (N3), IIIC, IVA, and IVB NSCLC, including leptomeningeal carcinomatosis or other central nervous system (CNS) metastases
History of noninfectious pneumonitis that required the use of systemic corticosteroids, history of interstitial lung disease, treatment-related pneumonitis (any grade), or any evidence of clinically active interstitial lung disease
Unable to swallow tablets or has any disease or condition that may significantly effect gastrointestinal (GI) absorption of zipalertinib (such as active inflammatory bowel disease, malabsorption syndrome, or prior GI resection)
History of other malignancy within the past 2 years, with the following exceptions:
Malignancy treated with curative intent before enrollment, with no known active disease and felt to be at low risk for recurrence by the treating physician, after discussion with the medical monitor.
Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease.
Adequately treated cervical carcinoma in situ without evidence of disease.
Adequately treated breast ductal carcinoma in situ disease or early stage breast cancer without evidence of disease.
Prostatic intraepithelial neoplasia without evidence of prostate cancer, or localized prostate cancer that is adequately treated.
Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ
Diagnosis of myelodysplastic syndrome (MDS) requiring active MDS-directed treatment
History of allogeneic organ transplant
History of hypersensitivity to carboplatin or pemetrexed or any excipients of zipalertinib
History of myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 3 months prior to first dose of study treatment
History of cerebral vascular accident (e.g., stroke or transient ischemic attack) within 3 months prior to first dose of study treatment
History of uncontrolled seizures
Human immunodeficiency virus (HIV) infection.
Participants with HIV infection on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on study per local or institutional guidelines
HIV screening is not required in the absence of clinical suspicion
Active hepatitis C infection.
Defined as participants with detectable hepatitis C antibody \[HCV Ab\] and hepatitis C virus \[HCV\] ribonucleic acid (RNA) viral load above the limit of quantification
Participants with presence of HCV antibody (HCV Ab positive) and HCV RNA viral load below the limit of quantification (HCV RNA negative) with or without prior treatment are allowed
Active hepatitis B infection.
Defined as presence of hepatitis B surface antigen \[HBsAg-positive\] and hepatitis B virus \[HBV\] DNA viral load above the limit of quantification \[HBV DNA positive\]
Participants with resolved HBV infection defined as absence of HBV surface antigen (HBsAg-negative) and presence of HBV core antibody (anti-HBc positive) followed by an HBV DNA viral load below the limit of quantification (HBV DNA negative) are allowed, with a requirement for regular monitoring for reactivation for the duration of treatment on the study and assessing the need for HBV prophylaxis therapy per local or institutional guidelines.
Participants with chronic HBV infection inactive carriers state, defined as presence of HBV surface antigen (HBsAg-positive) and HBV DNA viral load below the limit of quantification (HBV DNA negative) are allowed, with a requirement for regular monitoring for reactivation for the duration of treatment on the study and assessing the need for HBV prophylaxis therapy per local or institutional guidelines
Any condition (concurrent disease, infection, or comorbidity), in the opinion of the Investigator, that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data
What this trial measures
- Major pathologic responseAt time of surgery
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.