Study on Zipalertinib with Carboplatin and Pemetrexed for Treating Resectable Stage II-IIIB Non-Small Cell Lung Cancer

Sponsor: Jonsson Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07229339

Provider View

This clinical trial is testing a combination of drugs, including zipalertinib, carboplatin, and pemetrexed, to see if they can effectively treat stage II-IIIB non-small cell lung cancer that can be removed by surgery.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well the combination of zipalertinib, carboplatin, and pemetrexed works in treating stage II-IIIB non-small cell lung cancer (NSCLC) that can be surgically removed. Zipalertinib may help stop tumor growth by blocking certain enzymes needed for cell growth. Carboplatin and pemetrexed are chemotherapy drugs that work by killing or slowing the growth of cancer cells. This study aims to see if this combination can kill more cancer cells in patients with resectable NSCLC.

Description

The main goal of this study is to see how well the combination of zipalertinib, carboplatin, and pemetrexed works in shrinking tumors before surgery in patients with specific types of non-small cell lung cancer (NSCLC). Researchers will also look at how safe and tolerable this treatment is for patients.

Patients will take zipalertinib by mouth twice a day and receive carboplatin and pemetrexed through an IV on the first day of each treatment cycle. Each cycle lasts 21 days, and patients will undergo four cycles before surgery. After surgery, patients will continue taking zipalertinib for up to 13 more cycles.

Throughout the study, patients will have scans and provide blood and urine samples to monitor their health and the treatment's effectiveness. After completing the treatment, patients will have follow-up visits to check their progress and health status.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and able to provide informed consent.
  • Have a confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC) with specific EGFR mutations.
  • Cancer must be stage II, IIIA, or IIIB and able to be surgically removed.
  • No prior treatment for lung cancer.
  • Have at least one measurable tumor.
  • Be in good overall health with a performance status of 0 or 1.
  • Have adequate blood cell counts and organ function.
  • Women must not be pregnant or breastfeeding and must use effective contraception during and after treatment.
  • Able to comply with study requirements.

Exclusion Criteria

  • Currently participating in another clinical study with treatment.
  • Have received any cancer treatment within 30 days before starting the study.
  • Have a history of certain lung diseases or conditions affecting the ability to swallow or absorb medication.
  • Have had another cancer within the past two years, with some exceptions.
  • Have a history of organ transplant or severe allergic reactions to study drugs.
  • Have certain heart conditions or recent strokes.
  • Have uncontrolled seizures or active infections like HIV, hepatitis B, or hepatitis C.
  • Have any condition that, in the investigator's opinion, interferes with the study or poses a risk.

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