Phase 2: testing Osimertinib for Lung Cancer

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Osimertinib. The registry lists allocation as na. This study wants to measure how well it works and safety of osimertinib as induction therapy prior to curative intent RT and maintenance osimertinib in chemotherapy ineligible or refusal adult patients with Stage III, unresectable NSCLC with common EGFR mutations (exon 19 deletion or L858R).

They plan to enroll about 60 people at 17 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Phase II, Single-arm Multicenter Study of Osimertinib Induction Before Radiotherapy and Maintenance in Chemo-ineligible or Refusing Patients With Stage III, Unresectable NSCLC and EGFR Mutation-positive Tumors

Interventions: Osimertinib

Primary outcome (registry wording): PFS (Progression-Free Survival)

Who it is for (from inclusion criteria)

• Ages 18 Years to any
• Participants who had recurred from Stage I/II/III after complete surgery or had gross incomplete resections can be included if they didn't receive treatment with any chemotherapy, radiation therapy, immunotherapy, targeted therapy, or investigational agents
• Participants with availability of the EGFRm test results confirming that the tumor harbors 1 of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including de novo T790M
• WHO performance status of 0, 1 or 2 with no deterioration over the previous 2 weeks prior to baseline at screening and prior to first dose
• Participants who are eligible for and planning to undergo RT treatment per physician assessment
• Participant refusal or ineligible for chemotherapy per physician assessment
• Minimum life expectancy of \> 12 weeks at Day 1
• At least one lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI and is suitable for accurate repeated measurements