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Table 3 Ongoing Neoadjuvant Clinical Trials Containing ICI with Chemotherapy for Patients with 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]

NCT02572843

PD-L1 expression

Durvalumab + Cisplatin/Docetaxel + 

II

68

IIIA (N2)

EFS

June 16, 2016—December 2021 [76]

NCT03425643 (KEYNOTE-671)

PD-L1 expression

Pembrolizumab + platinum doublet versus platinum doublet

III

786

IIB, IIIA

EFS, OS

April 24, 2018—June 29, 2026

NCT03456063 (IMpower-030)

PD-L1 expression

Atezolizumab + platinum doublet versus platinum doublet

III

302

II-IIIA, select IIIB (T3N2)

MPR

April 24, 2018—January 20, 2025

NCT02818920 (TOP1501)

PD-L1 expression

Pembrolizumab (neoadjuvant + adjuvant)

II

32

IB-IIIA

Surgical feasibility

January 2017 – March 2026

NCT04304248 (NeoTAP01)

PD-L1 expression

Toripalimab + albumin-bound Paclitaxel + Carboplatin

II

30

IIIA and IIIB with T3N2 disease

MPR

August 1, 2019—July 30, 2026

NCT04422392

PD-L1 expression

Carboplatin, Pemetrexed or Nab-paclitaxel, PD-1 antibody

II

107

IIIA- N2

PFS

July 13, 2020—June 30, 2025

NCT03480230

PD-L1 expression

Compound 121,564 + chemotherapy depending on tumor histology

II

60

IB (tumor ≥ 4 cm in size, or grade 3, or with visceral pleura involvement), II or IIIA disease

ORR

June 26, 2018—November 2022

NCT04728724

PD-L1 expression

Sintilimab ± chemotherapy

II

100

III

MPR

January 21, 2021—December 31, 2027

NCT03425643

PD-L1 expression

Pembrolizumab + platinum doublet neoadjuvant chemotherapy

III

786

II, IIIA, and resectable IIIB (T3-4N2)

EFS, OS

April 24, 2018—June 29, 2026

NCT04865705

PD-L1 expression

Tilelizumab + Albumin Paclitaxel + Carboplatin/Cisplatin

II

33

III (T2N2, T3-4N1-2)

R0

November 10, 2020—June 10, 2022

NCT04326153

PD-L1 expression

Sintilimab + Albumin paclitaxel + Carboplatin

II

40

IIIA

DFS

December 15, 2019—December 2022

NCT04638582

PD-L1 expression

Pembrolizumab versus Pembrolizumab + platinum doublet chemotherapy

II

44

IA3, IB and IIA

ctDNA resolution

June 2021—March 2024

NCT04646837

PD-L1 expression

Durvalumab + Paclitaxel + Carboplatin

I/II

20

IB-IIIA

MPR

May 2021—March 2025

NCT04586465 (DYNAPET)

PD-L1 expression

Pembrolizumab + Pemetrexed + Gemcitabine + Cisplatin + Carboplatin

II

23

IIA—IIIB

MPR, dynamic SUV change, ORR, uptake rate constant (Ki)

October 10, 2020—June 30, 2022

NCT03800134 (AEGEAN)

PD-L1 expression

Durvalumab + platinum-based chemotherapy

III

800

IIA to select IIIB

pCR, EFS

December 6, 2018—April 30, 2024

NCT04379635

PD-L1 expression

Tislelizumab + Cisplatin/Carboplatin + Paclitaxel or Pemetrexed

III

380

II or IIIA

MPR, EFS

May 29, 2020—November 2025

NCT04338620

PD-L1 expression

Camrelizumab + albumin-bound Paclitaxel and Cisplatin

II

94

IIIA-IIIB

pCR

March 12, 2020—November 2021

NCT04840290

PD-L1 expression

Sintilimab + Platinum Doublet Chemotherapy

III

30

IIIA

ORR, R0 Resection Rate

June 1, 2019—June 1, 2023

NCT04699721

PD-L1 expression

Nivolumab + Paclitaxel + Carboplatin

I

40

IIIA and IIIB (T3N2)

Adverse effects, surgical complications, non-R0 surgical events

July 1, 2020—December 2027

NCT04459611 (neoSCORE)

PD-L1 expression

Sintilimab + Chemotherapy

II

60

IB-IIIA

MPR

July 1, 2020—July 1, 2023

NCT04025879

PD-L1 expression

Neoadjuvant Nivolumab + Platinum-based Doublet Chemo followed by Adjuvant Nivolumab

III

452

IIA-IIIB

EFS

September 16, 2019—September 30, 2024

NCT03732664

PD-L1 expression

Nivolumab + Pembrolizumab

I

40

IA3 (≥ 2 cm), II and IIIA

Safety and adverse effects

October 1, 2018—October 31, 2027

NCT04541251

PD-L1 expression

Camrelizumab + Nab-paclitaxel + Carboplatin

II

40

IB-IIIA

MPR

August 1, 2020—September 30, 2023

NCT04158440

PD-L1 expression

Toripalimab + Platinum doublet chemotherapy

III

406

IIIA

MPR, EFS

November 1, 2019—May 31, 2025

NCT04316364

PD-L1 expression

SHR-316 (anti-PD-L1 antibody) + Carboplatin + Paclitaxel

III

456

II, IIIA, IIIB

MPR, EFS

July 14, 2020—May 2026

NCT03916627

PD-L1 expression

Cemiplimab + Platinum doublet (NSCLC cohort)

II

94

Not specified

MPR, STN, MTE

July 23, 2019—August 7, 2027

NCT04865250 (iReP)

PD-L1 expression

Atezolizumab + Carboplatin/nab Paclitaxel

II

20

II, IIIA, IIIB

MPR

January 7, 2021—December 30, 2024

NCT04348292

PD-L1 expression

Durvalumab + Sirolimus

I

31

I, II, IIIa

Adverse events, pCR

March 10, 2021—December 25, 2025

NCT04560686

PD-L1 expression

TGF-beta

Bintrafusp Alfa

II

23

I-IIIA disease and IIIB (T3N2 only, and N2 single station)

MPR

August 5, 2020—October 1, 2024

NCT04061590

PD-L1 expression

Pembrolizumab versus Pembrolizumab + Cisplatin/Pemetrexed

II

84

I-IIIA

Tumor-infiltrating immune cells (TIICs)

May 29, 2020—April 30, 2022

NCT04015778

PD-L1 expression

Nivolumab + Carboplatin/ nab-Paclitaxel

II

48

IB-IIIA

MPR

August 8, 2019—July 2024

NCT04108013

PD-L1 expression

SHR-1210 (PD-1 antibody) + Carboplatin + Paclitaxel-albumin

II

38

II-IIIA

MPR

October 8, 2019—July 31, 2021

NCT03623776

PD-L1 expression

JS001 (Toripalimab) + Pemetrexed/Carboplatin

II

80

IB (≥ 4 cm), II and IIIA

DFS

February 1, 2019—March 1, 2024

  1. Abbreviations: AE adverse event, ctDNA circulating tumor DNA, ORR overall response rate, pCR pathological complete response, MPR major pathological response, DFS disease-free survival, EFS event-free survival, PFS progression free survival, OS overall survival, MTE major treatment effect, STN significant tumor necrosis, TIICs tumor-infiltrating immune cells. Blue highlights phase III studies