Table Info

Table 3.

Summary of past and ongoing neoadjuvant targeted therapy clinical trials

Trial	Phase	Stage	Mutation	Treatment	Control	Primary endpoint	Result
ESTERN [79]	II	IIIA	EGFR	Erlotinib × 2 years	None	Radical resection rate	60%
NCT00600587 [89]	II	IIIA (N2)	EGFR	Erlotinib × 6 weeks	Chemotherapy	Response rate	58.3% erlotinib vs. 25.0% chemotherapy (P = 0.18)
NCT01217619 [80]	II	IIIA	EGFR	Erlotinib × 8 weeks	None	Radical resection rate	68.4%
EMERGING-CTONG 1103 [81]	II	IIIA (N2)	EGFR	Erlotinib × 6 weeks	Chemotherapy	ORR	54.1% erlotinib vs. 34.3% chemotherapy (95% CI: 0.87–5.84, P = 0.092)
NCT03203590	III	II–IIIA	EGFR	Gefitinib × 8 weeks	Chemotherapy	DFS	N/A
NeoADAURA [84]	II	II–IIIA	EGFR	Osimertinib ± chemotherapy	Chemotherapy	mPR	N/A
NCT03433469 [90]	II	I–IIIA	EGFR	Osimertinib	None	mPR	15%
ChiCTR1800016948 [83]	II	IIA–IIIB	EGFR	Osimertinib × 6 weeks	None	ORR	71.1% (95% CI: 55.2–83.0)
NOCE01 (NCT05011487)	II	IIIA (N2)	EGFR	Osimertinib × 60 days + chemotherapy × 2 cycles	None	Lymph node clearance rate	N/A
NCT03349203	II	IIIB, oligometastatic	EGFR	Icotinib × 8 weeks as neoadjuvant therapy, then 2 years as adjuvant therapy	None	ORR	N/A
NCT03749213	II	IIIA–N2	EGFR	Icotinib × 8 weeks as neoadjuvant therapy, then for 2 years as adjuvant therapy	None	ORR	N/A
NCT04965831	II	IIIA–IIIB (N1–N2)	EGFR	Furmonertinib × 8 weeks as neoadjuvant therapy, then 2 years as adjuvant therapy	None	ORR	N/A
NCT05241028	II	IB–IIIA	EGFR	Ensartinib × 3 years	None	DFS	N/A
SAKULA [86]	II	II–III	ALK	Ceritinib × 12 weeks	None	mpR	57% (95% CI: 18–90)
RTOG 1306 (NCT01822496)	II	III	ALK	Crizotinib × 12 weeks	Placebo	PFS	N/A
ARM (NCT03088930)	II	IA–IIIA	ALK, ROS1, MET	Crizotinib × 6 weeks	None	ORR	N/A
ALNEO [88]	II	III	ALK	Alectinib × 8 weeks, adjuvant alectinib × 96 weeks	None	mPR	N/A
NAUTIKA-1 (NCT04302025)	II	IB–III	ALK, ROS1, NTRK, BRAF V600E, RET	Alectinib × 8 weeks, followed by adjuvant alectinib × 104 weeks	None	mPR	N/A

DFS: disease-free survival; OS: overall survival; mPR: major pathological response; ORR: objective response rate; EGFR: epidermal growth factor receptor; ALK: anaplastic lymphoma kinase; N/A: not applicable; PFS: progression free survival; CI: confidence interval

Declarations

Author contributions

RH and DJB: Conceptualization, Investigation, Supervision, Project administration, Writing—original draft, Writing—review & editing. ZLA and DP: Investigation, Writing—original draft, Writing—review & editing. All authors read and approved the submitted version.

Conflicts of interest

RH is a consultant for Targeted Oncology and Takeda and received honoraria from DAVA Oncology and The Dedham Group. DJB has the following disclosures: consulting or advisory role: Astellas, Eisai, Seagen; speakers’ bureau: Merck; travel and accommodations: Merck. Both other authors declare no conflicts of interest.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

Consent to publication

Not applicable.

Availability of data and materials

Not applicable.

Funding

Not applicable.

Copyright

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