Osimertinib With Chemotherapy as First-line Therapy for EGFR Mutation-positive NSCLC (NCT06376084) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Osimertinib With Chemotherapy as First-line Therapy for EGFR Mutation-positive NSCLC
China532 participantsStarted 2024-07-23
Plain-language summary
To estimate parameters related to clinical outcomes in a real-world seeting, including investigator reported PFS and OS .
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years
* Histologically or cytologically documented nonsquamous NSCLC. NSCLC of mixed histology is allowed.
* Stage IIIB or IIIC or Stage IV metastatic NSCLC or recurrent NSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative surgery or definitive chemoradiation.
* EGFR sensitive mutation-positive (Ex19del and/or 21 L858R)
* WHO performance status of 0 to 2 at screening with no clinically significant deterioration in the previous 2 weeks.
* Patients who receive Osimertinib plus chemotherapy as first-line treatment based on physician's medical assessment are eligible (For patients who received prior chemotherapy alone/Osimertinib monotherapy/Osimertinib plus chemotherapy as first-line therapy ahead of enrolment, they are diseases progression-free at the time of enrolment and the duration of prior therapy ≤3 months).
* Patients with asymptomatic CNS metastases or 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 are allowed.
* Prior adjuvant and neo-adjuvant therapies (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiation/chemoradiation with or without regimens including immunotherapy, biologic therapies, investigational agents are permitted as long as treatment was completed at least 12 months prior to the development of recur…
What they're measuring
1
Real-World Progression Free Survival (rwPFS)
Timeframe: Follow up approximately 36 months after last patient in