C349 Bronchus or lung, unspecified Bronchus or lung, unspecified
Conditions
Interventions
None listed
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2 Provision of signed and dated, written informed consent form prior to any mandatory study-specific procedures, sampling, and analyses. 3 For patients who agree to the optional genetic testing, provision of signed and dated genetic testing section of the written Main ICF prior to collection of a sample for genetic analysis for inclusion in the optional genetic research as allowed by local regulations. 4 Male or female, at least 18 years of age; patients from Japan at least 20 years of age. 5 Pathologically confirmed nonsquamous NSCLC 6 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. 7 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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS using Investigator assessment as defined by RECIST 1.1; Sensitivity analysis of PFS using BICR assessment as defined by RECIST 1.1 PFS=progression-free survival RECIST=Response Evaluation Criteria in Solid Tumors BICR=blinded independent central review NAME OF THE RESULT: To assess the efficacy of osimertinib plus chemotherapy treatment compared with osimertinib PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Every 6 then every 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS using Investigator assessment as defined by RECIST 1.1; Sensitivity analysis of PFS using BICR assessment as defined by RECIST 1.1 PFS=progression-free survival RECIST=Response Evaluation Criteria in Solid Tumors BICR=blinded independent central review NAME OF THE RESULT: To assess the efficacy of osimertinib plus chemotherapy treatment compared with osimertinib PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Every 6 then every 12 weeks.;OS; Landmark OS at 1, 2, and 3 years; ORR, DoR; depth of response; DCR by Investigator ORR=objective response rate OS=overall survival DoR=duration of response DCR=disease control rate NAME OF THE RESULT: To further assess the efficacy of osimertinib plus chemotherapy compared with osimertinib PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Till the end of the trial;PFS2; TFST; TSST PFS2=time from randomization to second progression on a subsequent treatment TFST = time to first subsequent therapy; TSST = time to second subsequent therapy NAME OF THE RESULT: To further assess the efficacy of osimertinib plus chemotherapy compared with osimertinib post progression PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Till the end of the trial;Change from baseline in EORTC QLQ-C30; Change from baseline in EORTC QLQ-LC13 EORTC QLQ- C30=European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 items; EORTC QLQ-LC13=European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – NAME OF THE RESULT: To assess disease related symptoms and Health related QoL in patients treated with osimertinib plus chemotherapy compared with osimertinib PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Monthly;Steady-state plasma concentrations and appropriate PK parame | — |
Countries
Argentina, Australia, Brazil, Canada, Chile, China, Czech Republic, France, India, Korea South, Philippines, Russian Federation, Slovakia, Taiwan, Thailand, United Kindgdom, United States
Outcome results
None listed