Skip to main content

Table 1 Ongoing trials for resectable earl-stage NSCLC patients that may change clinical practice in 5 years

From: Emerging evidence and treatment paradigm of non-small cell lung cancer

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

  1. *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