A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients W… (NCT04765059) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC)
United States, China98 participantsStarted 2021-09-12
Plain-language summary
The study will evaluate the efficacy and safety of treatment with chemotherapy in combination with osimertinib compared to chemotherapy in combination with placebo in patients whose disease has progressed extracranially following first-line osimertinib treatment.
Who can participate
Age range18 Years – 130 Years
SexALL
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Inclusion criteria
✓. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
✓. Pathologically confirmed non-squamous NSCLC.
✓. Locally advanced (clinical stage IIIB or IIIC) or metastatic NSCLC (clinical stage IVA or IVB) or recurrent NSCLC, not amenable to curative surgery or radiotherapy.
✓. Evidence of radiological extracranial disease progression following (Investigator-assessed) response or SD for ≥ 6 months during first-line osimertinib treatment, but who have not received further, subsequent treatment.
✓. Tumor known to harbor 1 of the 2 or both common epidermal growth factor receptor (EGFR) mutations known to be associated with EGFR tyrosine kinase inhibitor (TKI) sensitivity (Ex19del or L858R), either alone or in combination with other EGFR mutations, which may include T790M.
✓. World Health Organization performance status of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks.
✓. Life expectancy \>12 weeks at Day 1.
✓. At least 1 lesion, not previously irradiated, that can be accurately measured.
Exclusion criteria
✕. Clinical or radiological evidence of CNS progression on first-line osimertinib.
✕. Past medical history of interstitial lung disease (ILD)/pneumonitis, drug-induced ILD/pneumonitis, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD/pneumonitis.
What they're measuring
1
Progression Free Survival (PFS)
Timeframe: From date of first dose (Day 1) until date of progression at local site or death due to any cause or data cut-off date whichever occurred first (up to 3 years 1 month)
✕. Any evidence of severe or uncontrolled systemic diseases.
✕. Any of the following cardiac criteria:
✕. Any concurrent and/or other active malignancy that has required treatment within 2 years of first dose of investigational product (IP).
✕. Any unresolved toxicities from prior therapy.
✕. 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.
✕. More than 4 weeks elapsed since last dose of osimertinib by date of randomization.