Phase 2 Lung Cancer Trial, Completed NCT03434418 Sponsor: Duke University Condition: Lung Cancer
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 17 people, all of whom received the drug osimertinib. The trial was measuring how well the drug could shrink tumours in participants, as well as tracking how long it took for their disease to worsen and how long they survived overall. Of the 17 who started, 2 completed the study and 15 did not complete it (the reasons for this are not detailed in the reported data). The reported data shows that 8 out of 17 participants had their tumours shrink by a meaningful amount — meaning their scans showed either a large reduction in tumour size or the complete disappearance of detectable tumours. For the secondary measures, the reported data shows that the middle value (median) for progression-free survival — that is, the time before the disease worsened or a participant died — was 10.5 months. The reported overall survival figure — the time from starting treatment until death from any cause — was 13.8 months at the median. Regarding unwanted side effects, the reported data shows that 13 of the participants who received treatment experienced adverse events (unexpected or unwanted health changes noted during the trial), though the breakdown of specific types and severities involves multiple figures across different categories. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Lung Cancer Trial, Completed

NCT03434418
Completed Phase 2

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • Your lung cancer tumor has been tested in a certified lab and found to have one of these specific genetic changes: EGFR exon 18 G719X, exon 20 S768I, or exon 21 L861Q (having more than one mutation is allowed, as long as one of these is included).
  • You have been diagnosed with Stage 4 non-small cell lung cancer (NSCLC), confirmed by a tissue or cell sample.
  • Your cancer can be measured on a scan using standard guidelines.
  • Your recent blood tests (taken within 14 days of starting the study) show your blood counts, liver function, and kidney function are within acceptable ranges (confirm specific numbers with trial site).
  • Your heart's electrical activity (measured by an ECG) shows a normal reading within certain limits for your sex.
  • Your heart is pumping effectively, with a function level of at least 45%.
  • You are able to carry out normal daily activities with little or no limitation (confirm with trial site).
  • If you are a woman who could become pregnant, you have had a negative pregnancy test within 7 days of starting treatment and agree to use highly effective contraception; or you can show you cannot become pregnant (e.g., through menopause or surgical sterilisation, but not tubal ligation).
  • If you are a man, you are willing to use barrier contraception (such as condoms) during the trial.
  • You are 18 years of age or older.
  • You are willing and able to sign a consent form before any study procedures begin.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • You have previously been treated with a type of drug called an EGFR TKI (a targeted therapy for this type of lung cancer).
  • You have already received more than 2 rounds of systemic treatment for your advanced lung cancer.
  • You have had chemotherapy or other cancer treatments within the last 14 days before starting the study drug.
  • You have taken another experimental drug recently (within 5 half-lives of that drug — confirm timing with trial site).
  • You have had another active cancer within the last 2 years, with the exception of certain skin cancers or early-stage cervical changes; and you must not currently be receiving treatment (such as hormonal therapy) for any previous cancer.
  • You have had radiation therapy within the last 14 days.
  • You have brain metastases (cancer that has spread to the brain) that are causing symptoms and have not been treated; treated brain metastases may be allowed if it has been more than 14 days since radiotherapy ended and your condition is stable.
  • You have serious problems absorbing medication through your digestive system, ongoing nausea and vomiting, chronic gut conditions, difficulty swallowing, or have had major bowel surgery that could prevent the study drug from being absorbed properly.
  • Your tumor also has certain other specific EGFR genetic changes (T790M, exon 19 deletion, L858R, or exon 20 insertion), even if found alongside the qualifying mutations.
  • You are currently pregnant or breastfeeding, as the effects of the study drug on an unborn baby or nursing infant are unknown.
  • You have moderate or severe eye problems such as blurred vision, eye inflammation, corneal ulcers, very dry eyes, or a specific eye condition called keratitis (confirm grading with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 17 August 2026

GP referral letter

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Trial details

Status
Completed
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
30 June 2018
Est. completion
12 October 2022

Where this trial was run

🇺🇸 United States

These are the locations recorded on the registry, and they are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

Objective Response Rate as Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 17 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov