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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.

Phase 2RecruitingSun Yat-sen UniversityNCT06563999Data as of May 2026

Treatment: Sunvozertinib · Crizotinib · Pralsetinib · Larotrectinib · Savolitinib · Pyrotinib · Dabrafenib+Trametinib · Glecirasib · EnsartinibThis 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.

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Extracted 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

No prior treatment (treatment-naive required)
Max 0 prior lines

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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