Phase 2 Study of Targeted Combination Therapy in EGFR-Mutated Advanced NSCLC
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62-year-old female diagnosed with metastatic lung adenocarcinoma in late 2024. Next-generation sequencing confirmed EGFR Exon 19 deletion (p.E746_A750del). T790M and C797S negative. Completed 14 months of erlotinib with recent oligoprogression in right lower lobe on restaging CT. Asymptomatic stable brain metastasis treated with stereotactic radiosurgery 6 months prior. Normal hematologic and hepatic parameters. ECOG PS 1.
- Matches required EGFR Exon 19 deletion by tissue NGS
- Disease progression on 1st-generation TKI satisfies prior line criteria
- Stable treated brain metastases are protocol-eligible
- Located 4.2 miles from trial center (Dana-Farber/BWH)
58-year-old male with recurrent Stage IV NSCLC. Molecular profiling positive for EGFR L858R point mutation in Exon 21. Prior therapy includes carboplatin/pemetrexed doublet chemotherapy followed by osimertinib maintenance. Demonstrated new pleural effusion and solitary bone lesion on surveillance PET/CT. ECOG PS 0, normal renal and hepatic function, patient eager for clinical study enrollment.
- Sensitizing EGFR L858R mutation confirmed
- Meets prior therapy progression criteria
- Outstanding performance status (ECOG 0) and organ reserve
- Local Boston area resident (8.5 miles)
67-year-old male with locally advanced unresectable NSCLC. Molecular testing positive for EGFR Exon 19 deletion. Completed concurrent chemoradiation 8 months ago. Recent thoracic CT shows enlarging paratracheal lymph nodes. No systemic metastases. ECOG PS 1.
- EGFR Exon 19 deletion confirmed
- Locally recurrent disease post-chemoradiotherapy
- Acceptable organ function and performance status
- Convenient transit to trial site
54-year-old female diagnosed with EGFR-mutated adenocarcinoma (L858R). Developed secondary progression with new osseous lesions. ECOG PS 1. Patient profile indicates an active search for targeted clinical trials and willingness to travel within New England.
- Confirmed EGFR primary sensitizing mutation
- Within 50-mile study protocol catchment region
- Patient actively seeking second-line clinical studies
71-year-old male with metastatic squamous cell lung carcinoma. Next-gen panel negative for EGFR mutations. PD-L1 TPS 75%. Received first-line pembrolizumab. ECOG PS 2 with moderate dyspnea on exertion.
- Excluded: Squamous histology (study requires non-squamous adenocarcinoma)
- Excluded: Lacks required EGFR Exon 19 del or L858R mutation
- Excluded: ECOG 2 exceeds protocol performance threshold (ECOG 0-1)
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