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Clinical Trials List

Protocol NumberD5169C00001
NCT Number(ClinicalTrials.gov Identfier)NCT04035486
Active

2019-06-10 - 2026-09-30

Phase III

Recruiting9

Terminated4

ICD-10C33

Malignant neoplasm of trachea

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.0

Malignant neoplasm of trachea

A phase III, open-label, randomized study of osimertinib with or without platinum plus pemetrexed chemotherapy, as first-line treatment in patients with epidermal growth factor receptor (EGFR) mutation-positive, locally advanced or metastatic non-small cell lung cancer (FLAURA2)

  • Trial Applicant

  • Sponsor

    AstraZeneca

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Po-Hao Feng Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林聖皓 Division of Thoracic Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 林智斌 Division of Thoracic Medicine
Hualien Tzu Chi Hospital

Co-Principal Investigator

  • 王佐輔 Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Te-Chun Hsia Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Inn-Wen Chong Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳銘芳 無
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 楊聰明 無
Chiayi Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Ying Liu 無
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chi-Lu Chiang Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

A phase III, open-label, randomized study of osimertinib with or without platinum plus pemetrexed chemotherapy, as first-line treatment in patients with epidermal growth factor receptor (EGFR) mutation-positive, locally advanced or metastatic non-small cell lung cancer (FLAURA2)

Objectives

To assess disease-related symptoms and health-related QoL in patients treated with osimertinib plus chemotherapy compared with osimertinib - To assess the PK of osimertinib when given with or without chemotherapy - To compare the local EGFR mutation test result used for patient selection with the retrospective central cobas® EGFR Mutation Test v2 results from baseline tumor samples - To determine efficacy of osimertinib monotherapy vs. osimertinib combined with chemotherapy based on the cobas® EGFR Mutation Test v2 plasma screening test result for Exon 19 deletions or L858R EGFR mutations

Test Drug

Osimertinib (AZD9291/TAGRISSO®)

Active Ingredient

Osimertinib

Dosage Form

tab

Dosage

80
40

Endpoints

To assess disease-related symptoms and health-related QoL in patients treated with osimertinib plus chemotherapy compared with osimertinib
- To assess the PK of osimertinib when given with or without chemotherapy
- To compare the local EGFR mutation test result used for patient selection with the retrospective central cobas® EGFR Mutation Test v2 results from baseline tumor samples
- To determine efficacy of osimertinib monotherapy vs. osimertinib combined with chemotherapy based on the cobas® EGFR Mutation Test v2 plasma screening test result for Exon 19 deletions or L858R EGFR mutations

Inclution Criteria

1. Male or female, at least 20 years of age.
2. Pathologically confirmed nonsquamous NSCLC D5169C00001_KMUH_English Synopsis_Version 1.0, 19Mar2019 7
3. Newly diagnosed locally advanced (clinical stage IIIB, IIIC) or metastatic NSCLC (clinical stage IVA or IVB) or recurrent NSCLC (per Version 8 of the International Association for the Study of Lung Cancer [IASLC] Staging Manual in Thoracic Oncology), not amenable to curative surgery or radiotherapy.
4. The tumor harbors 1 of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del or L858R), either alone or in combination with other EGFR mutations, which may include T790M, assessed by a CLIA-certified (US sites) or an accredited (outside of the US) local laboratory or by central prospective tissue testing.
5. Mandatory provision of a baseline plasma sample and an unstained, archival tumor tissue sample in a quantity sufficient to allow for central confirmation of the EGFR mutation status. Patients must have untreated advanced NSCLC not amenable to curative surgery or radiotherapy. Prior adjuvant and neo-adjuvant therapies (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiation/chemoradiation with or without regimens including immunotherapy, biologic therapy, investigational agents, are permitted as long as treatment was completed at least 12 months prior to the development of recurrent disease.
6. WHO PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks.
7. Life expectancy >12 weeks at Day 1.
8. At least 1 lesion, not previously irradiated that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have a short axis of ≥15 mm) with CT or MRI, and that is suitable for accurate repeated measurements. If only 1 measurable lesion exists, it is acceptable to be used (as a target lesion) as long as it has not been previously irradiated and as long as it has not been biopsied within 14 days of the baseline tumor assessment scans.
9.Highly effective contraceptive measures must be taken.

Exclusion Criteria

1. Spinal cord compression; symptomatic and unstable brain metastases, except for those patients who have completed definitive therapy, are not on steroids, and have a stable neurological status for at least 2 weeks after completion of the definitive therapy and steroids. Patients with asymptomatic brain metastases can be eligible for inclusion if in the opinion of the
Investigator immediate definitive treatment is not indicated.
2. Past medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.
3. 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 trial or which would jeopardize compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
4. 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 QTcF value;
•Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG; eg, complete left bundle branch block, third-degree heart block, second-degree heart block;
•Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as electrolyte abnormalities including serum/plasma potassium*, magnesium* and calcium* below the LLN, heart failure, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant edication known to prolong the QT interval and cause Torsades de Pointes.
See Section 6.5.2 and Appendix G. * correction of electrolyte abnormalities to within normal ranges can be performed during screening
5. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
D5169C00001_KMUH_English Synopsis_Version 1.0, 19Mar2019 9
•Absolute neutrophil count below the lower limit of normal ( •Platelet count below the LLN*
•Hemoglobin <90 g/L*
*The use of granulocyte colony stimulating factor support, platelet transfusion and blood
transfusions to meet these criteria is not permitted.
•ALT >2.5 x the upper limit of normal (ULN) if no demonstrable liver metastases or >5 x ULN in the presence of liver metastases
•AST >2.5 x ULN if no demonstrable liver metastases or >5 x ULN in the presence of liver metastases
•Total bilirubin >1.5 x ULN if no liver metastases or >3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases
•Creatinine clearance <60 mL/min calculated by Cockcroft and Gault equation (refer to Appendix I for appropriate calculation)
6. Any concurrent and/or other active malignancy that has required treatment within 2 years of first dose of IP.
7. Any unresolved toxicities from prior systemic therapy (eg, adjuvant chemotherapy) greater than CTCAE Grade 1 at the time of starting study treatment, with the exception of alopecia and Grade 2 prior platinum-therapy related neuropathy.
8. 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.

The Estimated Number of Participants

  • Taiwan

    56 participants

  • Global

    586 participants

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