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New treatment option for Non-Small Cell Lung Cancer
Official title Osimertinib Then Chemotherapy in EGFR-mutated Lung Cancer with Osimertinib Third-line Rechallenge
ClinicalTrials.gov ID: NCT04335292
What this study is testing
What is Osimertinib First-Line?
Osimertinib First-Line is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for non-small cell 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 phase II single-armed study will examine the clinical utility of retreating patients with osimertinib, in the third-line, following first-line treatment with osimertinib and second-line treatment with platinum and pemetrexed chemotherapy. The current standard of care for first-line Epidermal Growth Factor Receptor (EGFR) mutated Advanced Non-Small Cell Lung Cancer (aNSCLC) is osimertinib, followed by cytotoxic chemotherapy.
- 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 18 and older
You may be able to join if
- Provision of informed consent prior to any study specific procedures
- Male or female patients of at least 18 years of age
- Pathologically proven advanced non-small cell lung cancer (i.e. stage M1 (metastasis), or earlier stages if unfit or unsuitable for radical...
- Patients must have a known activating Epidermal Growth Factor Receptor (EGFR) mutation. Atypical Epidermal Growth Factor Receptor (EGRF) mutations...
- Patients must have an Eastern Cooperative Oncology Group/World Health Organisation Performance Status (ECOG/WHO-PS) of 0-3 and an expectation that...
You likely can't join if
- Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or involved staff at the study site).
- A second invasive malignancy in the previous three years, other than localized non-melanoma skin cancer, which might be confused with the Epidermal...
- Any other serious and uncontrolled medical or psychiatric condition which would likely interfere in the conduct of the study.
- Pregnancy or lactation
- Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater.
- Currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent...
See the full eligibility criteria
Who can join
- Provision of informed consent prior to any study specific procedures
- Male or female patients of at least 18 years of age
- Pathologically proven advanced non-small cell lung cancer (i.e. stage M1 (metastasis), or earlier stages if unfit or unsuitable for radical treatment). Patients must have a tissue diagnosis of lung cancer, either by...
- Patients must have a known activating Epidermal Growth Factor Receptor (EGFR) mutation. Atypical Epidermal Growth Factor Receptor (EGRF) mutations are allowed. Atypical mutations may require sponsor approval. Exon 20...
- Patients must have an Eastern Cooperative Oncology Group/World Health Organisation Performance Status (ECOG/WHO-PS) of 0-3 and an expectation that they could potentially receive second-line chemotherapy
- Patients must have an expected life expectancy of at least 12 weeks
- 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 child-bearing potential or must have evidence of...
- Post-menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments
- Women under 50 years old are consider postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with Luteinizing Hormone (LH) and Follicle Stimulating...
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
- Male people should be willing to use barrier contraception
- Additional Criteria for patients enrolling after first-line progression and prior to second-line chemotherapy::
- people must have complete baseline demographic data available (age at diagnosis of metastatic non-small cell lung cancer, ethnicity, smoking status, sex, history of brain metastasis) and the following must be available...
- Additional Criteria for patients enrolling at the time of third-line osimertinib rechallenge:
- people must have complete baseline demographic data available (age at diagnosis of metastatic non-small cell lung cancer (NSCLC), ethnicity, smoking status, sex, history of brain metastasis) and the following must be...
- Patients must have received platinum/ pemetrexed chemotherapy in the second-line chemotherapy
- people must have measurable disease defined as at least one measurable lesion that can be accurately assessed by Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) at baseline and follow up visits.people...
What rules you out
- Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or involved staff at the study site).
- A second invasive malignancy in the previous three years, other than localized non-melanoma skin cancer, which might be confused with the Epidermal Growth Factor Receptor (EGFR) mutated lung cancer.
- Any other serious and uncontrolled medical or psychiatric condition which would likely interfere in the conduct of the study.
- Pregnancy or lactation
- Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater.
- Currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of Cytochrome P450 3A4 (CYP3A4) (at least 3 weeks prior)...
- Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2, prior...
- 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...
- Patients with spinal cord compression, symptomatic and unstable brain metastases except for those patients who have completed definitive therapy and have had a stable neurological status for at least 2 weeks after...
- 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.
- Past medical history of Interstitial Lung Disease (ILD), drug-induced ILD, 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 less than1.5 x 10 to the power of 9/L, platelet count less than 100 x 10 to the...
- History of hypersensitivity to any of the active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib.
- 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.
- Previous adjuvant cytotoxic chemotherapy within the 6 months prior to enrollment.
- Previous adjuvant anti programmed cell death protein 1(anti-PD-1) or anti programmed death-ligand 1 (anti-PD-L1) therapy within 90 days prior to enrollment.
- For patients enrolling prior to first-line treatment with osimertinib:
- Any previous systemic therapy for Epidermal Growth Factor Receptor mutated (EGFR+) advanced Non-Small Cell Lung Cancer (aNSCLC).
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) greater than 470 msec obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value
- 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.
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities [including serum/plasma potassium less than the Lower Limit of Normal (LLN)...
- For patients enrolling after progression on first-line osimertinib and prior to second-line chemotherapy all patients must have:
- Received osimertinib in the first-line and no other systemic therapy for their Epidermal Growth Factor Receptor mutated (EGFR+) Advanced Non-Small Cell Lung Cancer (aNSCLC).
- For patients enrolling at the time of third-line osimertinib rechallenge all patients must have:
- Received osimertinib in the first-line followed by second-line platinum (carboplatin/cisplatin) with pemetrexed (pemetrexed maintenance is permitted), and no other systemic therapy for their Epidermal Growth Factor...
- Received a minimum of 1 dose of platinum (carboplatin/cisplatin) with pemetrexed.
- At least 90 days have lapsed since the last dose of first-line osimertinib.
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
- Brampton, Ontario, Canada
- Hamilton, Ontario, Canada
- Kitchener, Ontario, Canada
- London, Ontario, Canada
- Oshawa, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada; Brampton, Ontario, Canada; Hamilton, Ontario, Canada; Kitchener, Ontario, Canada; London, Ontario, Canada; Oshawa, Ontario, Canada and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.