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. 2023 Apr 17;16:40. doi: 10.1186/s13045-023-01436-2

Table 1.

Ongoing trials for resectable earl-stage NSCLC patients that may change clinical practice in 5 years

Agents Agent type Control arm Identification status NCT/Name Sample size Primary endpoint
Neoadjuvant + Adjuvant

Neoad: Nivolumab + chemo

Adj: Nivolumab

 PD-1 inhibitor Placebo + chemo Stage II–IIIB (N2) Phase III NCT04025879 452 EFS

Neoad: Atezolizumab + chemo *4C

Adj: Atezolizumab*13C

 PD-1 inhibitor Placebo + chemo Stage II–IIIB (N2) Phase III

NCT03456063

(IMpower030)

 453 EFS

Neoad: Toripalimab + chemo*3C

Adj: Toripalimab + chemo*1C, Toripalimab*13C

 PD-1 inhibitor Placebo + chemo Stage II–IIIB (N2) Phase III NCT04158440 406

MPR rate in stage III population;

EFS in stage III population;

MPR rate in stage II–III population;

Neoad: Tislelizumab + chemo

Adj: Tislelizumab

 PD-1 inhibitor Placebo + chemo Stage II–IIIA Phase III NCT04379635 453 MPR; EFS
Neoadjuvant

Arm1: Osimertinib + chemo

Arm2: Osimertinib

 EGFR-TKI Placebo + chemo Stage II–IIIB N2 Phase III

NCT04351555

(NeoADAURA)

 328 MPR
Adjuvant

Arm1: Pembrolizumab + chemo*4C, pembrolizumab;

Arm2: chemo*4C, pembrolizumab

 PD-1 inhibitor Chemo Stage II–IIIB (N2) Phase III

NCT04267848

(ALCHEMIST)

 1210 DFS
Nivolumab + chemo*4C, nivolumab PD-1 inhibitor Chemo Stage IB–IIIA Phase III

NCT04564157

(NADIM-ADJUVANT)

 210 DFS
Nivolumab + chemo PD-1 inhibitor Chemo + observation Stage IB–IIIA Phase III

NCT02595944

(ALCHEMIST-ANVIL)

 903 DFS; OS
Durvalumab PD-1 inhibitor Placebo Stage IB–IIIA Phase III NCT02273375 1415 DFS
Durvalumab + chemo PD-1 inhibitor Placebo + chemo stage II–III NSCLC with MRD+ Phase III

NCT04385368

(MERMAID-1)

 89 DFS
Osimertinib EGFR-TKI Placebo Stage IA2–IA3 Phase III

NCT05120349

(ADAURA2)

 380 DFS in high-risk stratum

Arm1: 6-month icotinib;

Arm2: 12-month icotinib;

 EGFR-TKI Chemo Stage II–IIIA Phase III

NCT01996098

(ICTAN)

 318 DFS

Arm1: Almonertinib + Chemo;

Arm2: Almonertinib

 EGFR-TKI Chemo Stage II–IIIA Phase III

NCT04762459

(APEX)

 606 DFS
Almonertinib EGFR-TKI Placebo Stage II–IIIB (N2) Phase III NCT04687241 192 DFS
Gefitinib + chemo*4C, gefitinib EGFR-TKI Chemo Stage II–IIIB (N2) Phase III NCT03381066 225 DFS
Alectinib ALK-TKI Chemo Stage IB–IIIA Phase III

NCT03456076

(ALINA)

 257 DFS
Crizotinib ALK-TKI Observation Stage IB–IIIA Phase III

NCT02201992

(ALCHEMIST)

 168 OS
Ensartinib ALK-TKI Placebo Stage II–IIIB (N2) Phase III NCT05341583 202 DFS
Selpercatinib RET-TKI Placebo Stage IB–IIIA Phase III NCT04819100 170 EFS

*Chemo chemotherapy, DFS disease-free survival, EFS event-free survival, MPR major pathological response, OS overall survival, pCR pathological complete response, TKI tyrosine kinase inhibitor, C cycles