OncoMatch/Clinical Trials/NCT06563999
Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.
Is NCT06563999 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Small Cell Lung Cancer
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)
Demographics
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.
Frequently asked questions
Is NCT06563999 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require EGFR?
Yes, EGFR exon 20 insertion is a required biomarker for enrollment.
Does this trial require ROS1?
Yes, ROS1 fusion is a required biomarker for enrollment.
Does this trial require RET?
Yes, RET fusion is a required biomarker for enrollment.
Are patients with EGFR alterations eligible?
No. EGFR exon 19 deletion is an exclusion criterion.
Are patients with EGFR alterations eligible?
No. EGFR L858R is an exclusion criterion.
What disease stage is eligible?
Stage III is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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