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Table 4 Ongoing Neoadjuvant Clinical Trials Containing ICI with Either Other Immunotherapy or Targeted Therapy for Patients with resectable NSCLC

From: Emerging precision neoadjuvant systemic therapy for patients with resectable non-small cell lung cancer: current status and perspectives

ClinicalTrials.Gov Identifier

Biomarker(s)

Regimen

Phase

Sample Size

Stage

Primary Endpoint

Estimated or Actual Study Period [reference]

NCT05472623 (Neo-Kan)

KRASG12C

PD-L1 expression

Adagrasib BID prior to surgery versus Adagrasib BID and IV nivolumab every 2 weeks for 3 doses prior to surgery

II

42

IB-IIIA

pCR

November 20, 2022—November 20, 2025

NCT04941417

PD-L1 expression

PD-(L)1 inhibitor with chemotherapy

II

60

I (T ≥ 4 cm), IIA, IIB, IIIA, IIIB

MPR

November 24, 2020—June 30, 2023

NCT04379739

PD-L1 expression

VEGF

Camrelizumab + platinum-based chemotherapy versus Camrelizumab + Apatinib

II

82

II-IIIA

MPR

July 26, 2020—December 30, 2026

NCT04875585 (INNWOP1)

PD-L1 expression

VEGF

Pembrolizumab + Lenvatinib

II

33

IA3-IIIA

MPR

May 2021—December 2027

NCT04762030

PD-L1 expression

Durvalumab + Carboplatin + Nab-paclitaxel + Anlotinib

II

39

III

PFS

February 8, 2021—December 30, 2025

NCT04832854

PD-L1 expression

Atezolizumab + Tiragolumab with or without platinum-based chemotherapy

II

82

Stage II, IIIA, or select IIIB (T3N2 only)

Surgical delays, complications, surgical cancellations, adverse events, MPR

April 23, 2021—February 28, 2027

NCT04846634 (ALTER-L043)

PD-L1 expression

VEGFR

FGFR

PDGFR

c-kit

Penpulimab + chemotherapy versus Penpulimab + Anlotinib versus Penpulimab + chemotherapy + Anlotinib

II

90

IIB-IIIB (N2)

MPR

August 2021—February 2028

NCT04512430

PD-L1 expression

VEGF

Atezolizumab + Bevacizumab + Carboplatin + Pemetrexed

II

26

IIIA

MPR

December 2, 2020—August 2026

NCT04506242

PD-L1 expression

VEGF

Apatinib + neoadjuvant/adjuvant Camrelizumab

II

74

IIA-IIIB

MPR

September 15, 2020—December 30, 2025

NCT04123379

PD-L1 expression

Nivolumab + CCR2/5-inhibitor or anti-IL-8 (NSCLC cohort)

II

50

Not specified

MPR, STN

March 19, 2020—October 2024

NCT04040361 (EAST ENERGY)

PD-L1 expression

VEGF

Pembrolizumab + Ramucirumab

II

24

IB-IIIA

MPR

November 30, 2019—November 30, 2025

NCT04205552 (NEOpredict)

PD-L1 expression

LAG-3

Nivolumab + Relatlimab

II

60

I, II, IIIA

Feasibility

March 4, 2020 – June 2024

NCT03872661

PD-L1 expression

VEGF

Sintilimab + Bevacizumab + Pemetrexed + Carboplatin

II

36

III

Resectibility rate

March 1, 2019—March 1, 2024

NCT03968419 (CANOPY-N)

PD-L1 expression IL-1β

Pembrolizumab ± Canakinumab or Pembrolizumab monotherapy

II

110

IB-IIIA

MPR

November 5, 2019—March 21, 2023

NCT04758949

PD-L1 expression

IL-1ß

Nivolumab ± FL-101

II

90

IA3, IB, II, or IIIA

Adverse events

July 1, 2021—February 1, 2023

NCT04133337

PD-L1 expression

VEGF

SHR-1210 (PD-1 Antibody) + Apatinib

I/II

20

IB-IIIA

MPR

November 1, 2019—June 2021

  1. Abbreviations: AE adverse event, SAE severe adverse event, pCR pathological complete response, MPR major pathological response, DFS disease-free survival, EFS event-free survival, PFS progression free survival, OS overall survival, STN significant tumor necrosis