An Open-Label Randomized Phase II Study of Combining Osimertinib with and without Ramucirumab in TKI-naïve EGFR-mutant Locally Advanced or Metastatic NSCLC
Investigating Treatment Combinations for Advanced Lung Cancer
Brief description of study.
A phase II study for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) gene mutation, will test osimertinib with or without ramucirumab. Researchers hope to determine whether combining these drugs is better at controlling this type of cancer than osimertinib alone. To qualify, participants must be adults 18 or older and have locally advanced or metastatic NSCLC with EGFR.
Detailed description of study
A phase II study for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) gene mutation, will test osimertinib with or without ramucirumab. Researchers hope to determine whether combining these drugs is better at controlling this type of cancer than osimertinib alone. To qualify, participants must be adults 18 or older and have locally advanced or metastatic NSCLC with EGFR.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: non-squamous,non-small cell lung cancer
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria
Written informed consent and HIPAA authorization for release of personal health information prior to registration.
Age ≥ 18 years at the time of consent.
Histologically or cytologically confirmed non-squamous, non-small cell lung cancer.
Locally advanced or metastatic disease, not amenable to curative surgery or radiotherapy.
Ability to take pills by mouth.
Previous treatment with cytotoxic chemotherapy or immunotherapy is allowed.
Exclusion Criteria
Previous treatment with any EGFR TKIs, including erlotinib, gefitinib, afatinib, avitinib, dacomitinib, rociletinib, or osimertinib.
Previous treatment with any anti-VEGF medications, including vandetinib, nintedanib, bevacizumab, or ramucirumab.
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib.
Patients with uncharacterized eye disorders.
Males and females of reproductive potential who are not using and effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry.
Have undergone major surgery within 28 days prior to first dose of protocol therapy, or minor surgery/subcutaneous venous access device placement within 7 days prior to the first dose of protocol therapy. The patient has elective or planned major surgery to be performed during the course of the clinical trial
This study investigates the effectiveness of combining an investigational medication with another treatment for patients with advanced non-small cell lung cancer (NSCLC) that has a specific gene mutation called epidermal growth factor receptor (EGFR). NSCLC is a type of lung cancer, and EGFR mutations can affect how cancer grows. The purpose of this study is to see if using both treatments together is better at controlling the cancer than using one treatment alone.
Participants in this study will receive either the investigational medication alone or in combination with another treatment. They will take these treatments by mouth, which means they will swallow pills. The study will monitor the effects of the treatments on the cancer and any side effects that may occur.
- Who can participate: Adults aged 18 or older with locally advanced or metastatic non-small cell lung cancer and an EGFR mutation can participate. They must be able to take pills by mouth and have not been treated with certain previous medications.
- Study details: Participants will take either the investigational medication alone or with another treatment. They will need to swallow pills as part of the study.