Pemetrexed/Carboplatin / Osimertinib / Non Small Cell Lung Cancer · Phase 2 Trial
ClinicalTrials.gov · August 12, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 2 randomized controlled trial comparing osimertinib plus chemotherapy (pemetrexed/carboplatin) versus osimertinib monotherapy in EGFR-mutant NSCLC patients selected for persistent circulating tumour DNA at week 3. Recruitment is complete and the study is closed to enrolment; the primary PFS analysis is planned at approximately 30 months after randomization, but no results are yet reported in this registry record.
Phase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose. Non Small Cell Lung Cancer; age from 18 Years. Intervention: Osimertinib 80 mg QD and platinum-based chemotherapy. Compared with: Osimertinib 80mg QD — Active Comparator. n = 80. 1 site: China.
This is a Phase 2 randomized controlled trial comparing osimertinib plus chemotherapy (pemetrexed/carboplatin) versus osimertinib monotherapy in EGFR-mutant NSCLC patients selected for persistent circulating tumour DNA at week 3. Recruitment is complete and the study is closed to enrolment; the primary PFS analysis is planned at approximately 30 months after randomization, but no results are yet reported in this registry record.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This trial addresses a clinically relevant question: whether adding chemotherapy to osimertinib in patients with early ctDNA persistence (a marker of potential treatment resistance) improves outcomes. Results when available may inform management of a subset of EGFR-mutant NSCLC with poor early response.
Phase 2 randomized trial with planned PFS endpoint at ~30 months; recruitment completed but results not yet reported in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
This trial addresses a clinically relevant question: whether adding chemotherapy to osimertinib in patients with early ctDNA persistence (a marker of potential treatment resistance) improves outcomes. Results when available may inform management of a subset of EGFR-mutant NSCLC with poor early response.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04769388). This is a study registration, not published results. Lead sponsor: Beijing Cancer Prevention & Treatment Society. Recruitment status: COMPLETED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 80 participants (ACTUAL). Conditions: Non Small Cell Lung Cancer. Interventions: DRUG: Osimertinib; DRUG: Pemetrexed/Carboplatin. Primary outcome measures: Progression free survival , The primary analysis of Progression-free survival (PFS) based on investigator assessment will occur when PFS maturity is observed at approximately 30 months after the first patient is randomized.. Brief summary: This is a prospective, randomised, open-label, positive-controlled study to investigate the efficacy and safety of Osimertinib plus Carboplatin/Pemetrexed versus Osimertinib monotherapy in metastatic EGFRm NSCLC patients with EGFRm persistence in ctDNA at 3 weeks after first-line therapy with Osimertinib.
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