Study of zipalertinib plus chemotherapy versus placebo plus chemotherapy in patients with stage IB-IIIA non-small cell lung cancer with uncommon EGFR mutations after surgery
This study focuses on Non-Small Cell Lung Cancer (NSCLC) in stages IB-IIIA with uncommon EGFR mutations in patients who have had complete tumor removal through surgery. The study aims to evaluate whether adding zipalertinib to standard treatment with chemotherapy works better than chemotherapy with placebo in preventing cancer from returning after surgery.
The treatment involves taking zipalertinib or placebo tablets by mouth, combined with chemotherapy medications given through an intravenous infusion. The chemotherapy drugs used in this study are cisplatin, carboplatin, and pemetrexed. These medications are commonly used to treat lung cancer after surgery to reduce the risk of cancer coming back.
During the study, participants will be randomly assigned to receive either zipalertinib tablets or matching placebo tablets. Neither the participants nor their doctors will know which treatment they are receiving. The treatment period may last up to 36 months, during which participants will receive regular medical check-ups to monitor their health and evaluate how well the treatment is working.
1Initial treatment phase
You will receive treatment 4-10 weeks after your lung cancer surgery
Your treatment will combine chemotherapy given through an intravenous infusion with either zipalertinib tablets or placebo tablets
The chemotherapy will include either cisplatin or carboplatin, combined with pemetrexed
2Daily medication
You will take either zipalertinib tablets or placebo tablets daily as prescribed
The tablets should be taken by mouth according to the provided schedule
3Monitoring period
Regular assessments will check your health status and monitor for any changes in your condition
Brain scans (MRI or CT) will be performed as part of your follow-up care
Your doctor will monitor your organ function through blood tests
4Follow-up requirements
After completing treatment, you must use effective birth control for at least 1 month after the last dose of zipalertinib/placebo
If you received chemotherapy, birth control must continue for 6 months after the last dose
Your health status will continue to be monitored to assess the treatment’s effectiveness
5Study duration
The study is expected to run from October 2025 to December 2030
Your individual participation duration will be determined by your treatment plan
Who Can Join the Study?
Must be 18 years of age or older
Must provide written informed consent
Must have adequate organ function including:
Sufficient blood cell counts
Good kidney function
Normal blood clotting function
Normal liver function
Must have non-small cell lung cancer (NSCLC) that has been surgically removed with clear margins (no cancer cells at the edges of removed tissue)
Cancer must be classified as Stage IB, IIA, IIB, or IIIA
Must have specific genetic changes in the EGFR gene confirmed by laboratory testing
Must have had brain imaging (MRI or CT scan) before surgery or before starting the study
Must have fully recovered from surgery, with complete wound healing
Must start treatment between 4 and 10 weeks after surgery
Must be able to perform daily activities with minimal assistance (ECOG Performance Status of 0 or 1)
Must have tumor tissue available for laboratory testing
For women who can become pregnant:
Must have a negative pregnancy test within 7 days before starting treatment
Must use effective birth control during the study and for 1 month after last dose
For men who can father children:
Must use effective birth control during the study and for 6 months after last dose
Who Cannot Join the Study?
Age below 18 years or above 75 years
Previous treatment with any EGFR inhibitor (drugs that target specific proteins in cancer cells)
Known allergy or sensitivity to study medications
Active or untreated brain metastases (cancer that has spread to the brain)
Significant heart conditions including:
Uncontrolled high blood pressure
Recent heart attack (within 6 months)
Unstable heart rhythm problems
Severe kidney or liver dysfunction
Currently participating in another clinical trial
Pregnant or breastfeeding women
Any other active cancer requiring treatment
Major surgery within 4 weeks before starting the study
Any serious medical condition that could interfere with study participation
Zipalertinib is a targeted therapy medication used to treat non-small cell lung cancer (NSCLC). It specifically works by targeting uncommon mutations in the EGFR (epidermal growth factor receptor) gene. This medication is being studied in patients who have had their tumors surgically removed and are receiving chemotherapy to prevent cancer recurrence.
Chemotherapy refers to standard cancer-fighting drugs that are given after surgery (adjuvant therapy) to kill any remaining cancer cells and reduce the risk of cancer coming back. In this trial, chemotherapy is given to all patients along with either zipalertinib or placebo.
Non-small Cell Lung Cancer (NSCLC) – A type of lung cancer that begins in the epithelial cells of the lung tissue. The disease starts when abnormal cells in the lungs begin to grow and multiply uncontrollably, forming tumors. Stage IB-IIIA indicates that the cancer has grown into deeper lung tissues and may have spread to nearby lymph nodes. In cases involving EGFR mutations, the cancer cells have specific changes in the epidermal growth factor receptor gene, which affects how the cells grow and divide. NSCLC typically develops slowly and may not cause symptoms in its early stages.
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