A Phase 2 interventional study of Osimertinib plus platinum doublet chemotherapy in Lung Cancer (NSCLC), sponsored by The University of Hong Kong. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-09.
Sponsored by The University of Hong Kong · Phase 2, Interventional, and Treatment
The aims of this study are to determine the potential clinical benefits (in terms of PFS, objective response and OS) of add-on systemic chemotherapy (pemetrexed+carboplatin/cisplatin) to first-line osimertinib treatment among the poor prognostic group of metastatic EGFR-mutant lung adenocarcinoma, i.e. failure of plasma ctDNA EGFR mutant clearance at week 3 after osimertinib treatment
This is a single-arm clinical trial, subjects will be consented prior to the initiation of osimertinib (as per standard-of-care) with baseline plasma ctDNA EGFR mutations tested in QMH. Those with detectable baseline plasma ctDNA EGFR mutations will undergo a repeat plasma ctDNA test after 3 weeks (+/- 5 days) of osimertinib treatment. The screening period is within 42 days. Enrolled eligible subjects will be started on systemic chemotherapy (pemetrexed and carboplatin or cisplatin) within 6 weeks of starting osimertinib, with the following outcome measures:
Primary outcome: real-world 1-year progression-free survival (rw1yPFS) Secondary outcomes: rw response rate (rwRR), rw PFS (rwPFS), rw overall survival (rwOS), rw time-to-treatment discontinuation (rwTTD), ctDNA clearance rate
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's planned enrollment of 47 is close to the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Incorporating chemotherapy with ongoing osimertinib treatment involves initiating osimertinib at the standard dose of 80mg orally once daily. This regimen includes a combination of pemetrexed and carboplatin or cisplatin administered intravenously every 3 weeks for a maximum of 6 cycles, followed by maintenance pemetrexed at a dosage of 500mg/m2 every 3 weeks in cases of non-progressive disease.
Drug: Osimertinib plus platinum doublet chemotherapy
Based on the FLAURA2 study (which was not subdivided into ctDNA clearance subgroups), it is hypothesized that adding systemic chemotherapy to osimertinib will prolong PFS and OS and increase objective response rate even among the poor prognostic subgroup with failed ctDNA clearance after initial osimertinib monotherapy. By incorporating systemic chemotherapy (pemetrexed/carboplatin) to first-line osimertinib treatment among the poor prognostic group of metastatic EGFR-mutant lung adenocarcinoma with failure of plasma ctDNA EGFR mutant clearance despite initial osimertinib treatment.
real-world 1-year progression-free survival
Time frame: The duration of osimertinib treatment extends from the initiation of therapy until either disease progression or death from any cause, whichever occurs first. Progression-free survival (PFS) will be monitored for up to 1 year.
rw response rate
real world response rate
Time frame: From date of initiation of osimertinib therapy (day 1) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
OS
overall survival
Time frame: From date of initiation of osimertinib therapy (day 1) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
rw PFS
real world PFS
Time frame: The progression-free survival (PFS) will be assessed at the one-year mark.
rw time-to-treatment discontinuation
Time frame: From date of initiation of osimertinib therapy (day 1) until the date of first documented discontinuation or date of death from any cause, whichever came first, through study completion, an average of 1 year.
ctDNA clearance rate
Time frame: The plasma EGFR mutation ctDNA testing will be carried out by Cobas EGFR Mutation Test v2 (Roche Diagnostics) at baseline, 3, 6, 9 and 12 weeks of osimertinib treatment.
No study locations are listed for this record.
Plan to share: Undecided
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The University of Hong Kong