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NCT03909334
NCT03909334
Who may be able to join
Who might be able to join this trial:
- You must be at least 18 years old at the time you give your consent to participate.
- You must sign a consent form agreeing to take part and allowing your health information to be used for the study.
- Your lung cancer must have been confirmed by a lab test (using tissue or blood samples) and must be a specific type called non-squamous, non-small cell lung cancer (NSCLC).
- Your cancer must be at an advanced or spread-out stage that cannot be fully treated with surgery or radiation.
- Your lung cancer must have a specific genetic change — either an "EGFR Exon 19 deletion" or an "EGFR L858R mutation" — confirmed by a certified lab test.
- You must be in reasonably good general health, able to carry out normal daily activities with little or no limitation (confirm with trial site).
- Your cancer must be measurable on scans according to standard guidelines.
- If you have cancer that has spread to the brain, it must not be causing symptoms, must be treated, or must have been neurologically stable for at least two weeks — either without steroids or on a low, stable, or decreasing steroid dose.
- You must be able to swallow pills.
- Previous chemotherapy or immunotherapy treatment is allowed.
- Your blood counts, kidney function, liver function, and clotting must meet certain minimum levels based on blood tests done within the past 4 weeks (confirm specific values with trial site).
- If you are on blood-thinning medication, you must be on a stable dose for at least 14 days, with no active bleeding in the past 14 days.
- If you are a woman who could become pregnant, you must have a negative pregnancy test within 7 days of starting treatment.
- If you could father a child or become pregnant, you must agree to use an approved form of contraception throughout the trial.
Who may not be able to join:
- You cannot join if you are taking certain medications that strongly affect how the body processes drugs, or medications known to affect heart rhythm, and you are unable to stop taking them (confirm specific medications with trial site).
- You cannot join if you have been diagnosed with another cancer in the past 2 years, with some exceptions such as certain early-stage or skin cancers (confirm with trial site).
- You cannot join if you have previously been treated with certain targeted therapies for EGFR mutations, including erlotinib, gefitinib, afatinib, dacomitinib, rociletinib, or osimertinib.
- You cannot join if you have previously been treated with certain anti-blood vessel growth (anti-VEGF) medications, including bevacizumab, ramucirumab, vandetanib, or nintedanib.
- You cannot join if you have compression of the spinal cord that is causing symptoms or has not been stable for at least 2 weeks.
- You cannot join if you still have significant side effects from a previous cancer treatment that have not resolved.
- You cannot join if you have serious uncontrolled health conditions, such as uncontrolled high blood pressure, active bleeding disorders, or active infections including hepatitis B, hepatitis C, or HIV.
- You cannot join if you have severe nausea, vomiting, digestive system diseases, or a history of major bowel surgery that would prevent you from properly absorbing the study medication.
- You cannot join if you have a history of a serious lung condition called interstitial lung disease (ILD), or lung inflammation from radiation that required steroid treatment.
- You cannot join if you have undiagnosed or poorly understood eye conditions.
- You cannot join if you have had a previous allergic reaction to osimertinib or ramucirumab (the medications used in this trial).
- You cannot join if the trial team believes you are unlikely to follow the study rules and requirements.
- You cannot join if you have certain heart problems, including an abnormal heart rhythm reading on an ECG, a history of heart attack, stroke, or unstable chest pain within the past 6 months, a specific type of abnormal heart electrical reading above a certain threshold, or uncontrolled high blood pressure despite treatment (confirm specific details with trial site).
- You cannot join if you have had severe gastrointestinal (stomach or bowel) bleeding within the past 3 months.
- You cannot join if you
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Trial details
Status
Active, Not Recruiting
Phase
Phase 2
Sponsor
Xiuning Le
Registry
clinicaltrials_gov
Start date
25 July 2019
Est. completion
1 December 2026
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Progression Free Survival (PFS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.