OncoMatch/Clinical Trials/NCT06563999
Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.
Is NCT06563999 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for lung cancer stage iii.
Treatment: Sunvozertinib · Crizotinib · Pralsetinib · Larotrectinib · Savolitinib · Pyrotinib · Dabrafenib+Trametinib · Glecirasib · Ensartinib — This umbrella trial directed by next generation sequencing (NGS) includes patients with treatment-naive unresectable stage III non-small-cell lung cancer (NSCLC). The aim of the umbrella study is to evaluate the efficacy of induction NGS-directed targeted therapies followed by surgery for stage III NSCLC patients whose tumor harbors a rare mutation.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon 20 insertion
rare mutation based on NGS, including mutations of EGFR exon20ins
Required: ROS1 fusion
rare mutation based on NGS, including mutations of ... ROS1 fusion
Required: RET fusion
rare mutation based on NGS, including mutations of ... RET fusion
Required: NTRK1 fusion
rare mutation based on NGS, including mutations of ... NTRK fusion
Required: NTRK2 fusion
rare mutation based on NGS, including mutations of ... NTRK fusion
Required: NTRK3 fusion
rare mutation based on NGS, including mutations of ... NTRK fusion
Required: MET exon 14 skipping
rare mutation based on NGS, including mutations of ... MET 14 exon
Required: HER2 (ERBB2) mutation
rare mutation based on NGS, including mutations of ... HER2
Required: BRAF V600E
rare mutation based on NGS, including mutations of ... BRAF V600E
Required: KRAS G12C
rare mutation based on NGS, including mutations of ... KRAS G12C
Required: ALK fusion
rare mutation based on NGS, including mutations of ... ALK fusion
Excluded: EGFR exon 19 deletion
Subjects should be without EGFR exon 19 deletions
Excluded: EGFR L858R
Subjects should be without ... exon 21 L858R activating mutation
Excluded: EGFR sensitizing mutation
Subjects with known EGFR sensitive mutations
Disease stage
Required: Stage III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic antitumor therapy
Lab requirements
Blood counts
ANC ≥2.0 x 10^9/L, Platelet count ≥100 x 10^9/L, Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level)
Kidney function
Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min
Liver function
Total bilirubin ≤ 1.5 x ULN, AST, ALT ≤ 2.5 x ULN
Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 10^9/L, and Platelet count ≥100 x 10^9/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level); Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN; Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min;
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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