Table Info

Table 2.

Summary of past and ongoing adjuvant targeted therapy clinical trials

Trial	Phase	Stage	Mutation	Treatment	Control	Primary endpoint	Result
RADIANT [65]	III	IB–IIIA	EGFR	Erlotinib × 2 years	Placebo	DFS	50.5 months erlotinib vs. 48.5 months placebo; HR = 0.90, 95% CI: 0.74 to 1.10
SELECT [66]	II	IB–IIIA	EGFR	Erlotinib × 2 years	None	DFS	88% (96% stage I, 78% stage II, 91% stage III) vs. historic data of 76%
ADJUVANT/CTONG1104 [69]	III	II–IIIA	EGFR	Gefitinib × 2 years	Chemotherapy	DFS	28.7 months gefitinib (95% CI: 24.9–32.5) vs. 18.0 months chemotherapy (95% CI: 13.6–22.3); HR = 0.60, 95% CI: 0.42–0.87, P = 0.0054
EVAN [71]	II	IIIA	EGFR	Erlotinib × 2 years	Chemotherapy	DFS	81.4% (95% CI 69.6–93.1) erlotinib vs. 44.6% (26.9–62.4) chemotherapy
ADAURA [9]	III	IB–IIIA	EGFR	Osimertinib × 3 years	Placebo	DFS	90% (95% CI: 84–93) osimertinib vs. 44% (95% CI: 37–51); HR = 0.17, 99.06% CI: 0.11–0.26, P < 0.001
EVIDENCE [77]	III	II–IIIA	EGFR	Icotinib × 2 years	Chemotherapy	DFS	47.0 months icotinib (95% CI: 36.4–NYR) vs. 22.1 months chemotherapy (95% CI: 16.8-30.4); HR = 0.36, 95% CI: 0.24–0.55, P < 0.0001
ALCHEMIST-EGFR [75]	III	IB–IIIA	EGFR	Erlotinib × 2 years	Placebo	OS	N/A
ICOMPARE [78]	II	II–IIIA	EGFR	Icotinib × 1 year	Icotinib × 2 years	DFS	32.9 months icotinib for 1 year (95% CI: 26.6–44.8) vs. 48.9 months for 2 years (95% CI: 33.1–70.1); HR = 0.51; 95% CI: 0.28–0.94, P = 0.0290
FORWARD (NCT04853342)	III	II–IIIA	EGFR	Furmonertinib	Placebo ± chemotherapy	DFS	N/A
NCT04687241	III	II–IIIB	EGFR	Almonertinib	Placebo	DFS	N/A
NCT05241028	II	IB–IIIA	EGFR	Ensartinib × 3 years	None	DFS	N/A
ALINA (NCT03456076) [11]	III	IB–IIIA	ALK	Alectinib × 2 years	Chemotherapy	DFS	93.8% alectinib vs. 63.0% chemotherapy (HR = 0.24, 95% CI: 0.13–0.43, P < 0.001)
ALCHEMIST-ALK [75]	III	IB–IIIA	ALK	Crizotinib × 2 years	Placebo	OS	N/A

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

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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