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New treatment option for Lung Cancer
Official title Osimertinib to Suppress the Progression of GGN(EGFR Mutation-positive)
ClinicalTrials.gov ID: NCT04591002
What this study is testing
What is Osimertinib 80 MG?
Osimertinib 80 MG is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study designed to assess the efficacy of osimertinib (80 mg, orally, once daily) to suppress the progression of remaining GGN(s) in other lobes following surgical resection for actionable EGFR mutation-positive stage I lung adenocarcinoma.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 75
You may be able to join if
- Provision of informed consent prior to any study specific procedures
- Adult male or female patients, aged from 30 to 75 years
- Pathologic proven stage I lung adenocarcinoma with additional persistent GGNs in at least one other lobe: GGN is defined as a ground glass-opacity...
- The resected lung adenocarcinoma should have actionable EGFR mutation, which is limited to L858R or exon 19 deletion.
- WHO performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks
You likely can't join if
- Treatment with any neoadjuvant therapy (radiation, any cytotoxic chemotherapy, investigational agents or other anticancer drugs after surgery) before...
- Treatment with any adjuvant therapy (any cytotoxic chemotherapy, investigational agents or other anticancer drugs after surgery) before randomization
- Extensive surgery other than lobectomy or sublobar resection (i.e. bilobectomy, sleeve lobectomy, pneumonectomy)
- Past history of postoperative ALI/ARDS or pneumonia during recovery period
- Currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong...
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the...
See the full eligibility criteria
Who can join
- Provision of informed consent prior to any study specific procedures
- Adult male or female patients, aged from 30 to 75 years
- Pathologic proven stage I lung adenocarcinoma with additional persistent GGNs in at least one other lobe: GGN is defined as a ground glass-opacity with well-defined margin, mean density above -500 HU and greater than...
- The resected lung adenocarcinoma should have actionable EGFR mutation, which is limited to L858R or exon 19 deletion.
- WHO performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks
- Uneventful recovery from curative-intent lung cancer surgery
- Female people should be using highly effective contraceptive measures, and must have a negative pregnancy test and not be breast-feeding prior to start of dosing if of childbearing potential or must have evidence of...
- Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments
- Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal...
- Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation Further information in Appendix E (Definition of Women of Childbearing...
- Male people should be willing to use barrier contraception (see Restrictions, Section 3.8)
What rules you out
- Treatment with any neoadjuvant therapy (radiation, any cytotoxic chemotherapy, investigational agents or other anticancer drugs after surgery) before randomization
- Treatment with any adjuvant therapy (any cytotoxic chemotherapy, investigational agents or other anticancer drugs after surgery) before randomization
- Extensive surgery other than lobectomy or sublobar resection (i.e. bilobectomy, sleeve lobectomy, pneumonectomy)
- Past history of postoperative ALI/ARDS or pneumonia during recovery period
- Currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4 (at least 3 week prior) (Appendix C). All patients...
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the...
- 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.
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) \> 470 msec obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value. Whenever QTc, is mentioned in this document, this refers to...
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second degree heart block.
- Patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: Serum/plasma potassium \< LLN; Serum/plasma magnesium \< LLN...
- Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
- Inadequate bone marrow reserve or organ function (as demonstrated by any of the following laboratory values:
- Absolute neutrophil count \<1.5 x 109/L;
- Platelet count \<100 x 109/L;
- Haemoglobin \<90 g/L;
- Alanine aminotransferase \>2.5 times ULN if no demonstrable liver metastases or \>5 times ULN in the presence of liver metastases;
- Aspartate aminotransferase \>2.5 times ULN if no demonstrable liver metastases or \>5 times ULN in the presence of liver metastases;
- Total bilirubin \>1.5 times ULN if no liver metastases or \>3 times ULN in the presence of documented Gilbert's Syndrome [unconjugated hyperbilirubinaemia] or liver metastases;
- Serum creatinine \>1.5 times ULN concurrent with creatinine clearance \ 1.5 times ULN.
- Women who are breast-feeding.
- 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.
- Involvement in the planning and conduct of the study (applies to AstraZeneca staff or staff at the study site).
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Kangnamgu, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Kangnamgu, South Korea; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.