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KCSG: Paving the way to a cancer-free world Contact info e-mail. [email protected] website. www.kcsg.org Address 4F, 15, Teheran-ro 84-gil, Gangnam-gu, Seoul 06179, Rep. of Korea Dedicated to the advancement of cancer clinical trials 2020 Brief Annual Report

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Page 1: Dedicated to the advancement of cancer clinical trialspositive, HER2-negative metastatic breast cancer (KCSG-BR15-10): a multicentre, open-label, randomised, phase 2 trial. KCSG BR10-04

KCSG: Paving the way to a cancer-free world

Contact info e-mail. [email protected] website. www.kcsg.org

Address 4F, 15, Teheran-ro 84-gil, Gangnam-gu, Seoul 06179, Rep. of Korea

Dedicated to the advancement of cancer cl inical trials

2020 Brief Annual Report

Page 2: Dedicated to the advancement of cancer clinical trialspositive, HER2-negative metastatic breast cancer (KCSG-BR15-10): a multicentre, open-label, randomised, phase 2 trial. KCSG BR10-04

Korean Cancer Study Group (KCSG) is the nation’s leader in multi-institutional clinical trials for cancer treatment.

Since our establishment in 1998, KCSG has been dedicated to the advancement of clinical and translational cancer research through multi-institutional clinical trials in Korea.

WHO WE ARE

• KCSG: Paving the way to a cancer-free world

KCSG AT A GLANCE

RESEARCH FIELD

• To design and conduct practice changing clinical trials

• To promote international collaborative cancer research

• To optimize multidisciplinary team science in cancer research

• To implement education and training on cancer treatments and clinical trials

• To improve public access to cancer clinical trials

GOAL

VISION

Individual members dedicated cancer research

Cancer centers & hospitals in Korea

Publications Alliances with global study groups

Clinical studies since 1998 Enrolled patients

850+ 110+

80+ 6+

180+ 36,000+

• Hepatobiliary & Pancreatic Cancer

• Genitourinary Cancer & Gynecologic Cancer

• Head & Neck and Esophageal Cancer

• Breast Cancer

• Lung Cancer

• Colorectal Cancer

• Stomach Cancer

• Lymphoma

• Palliative Care

• Rare Cancer

KCSG

2 3

Page 3: Dedicated to the advancement of cancer clinical trialspositive, HER2-negative metastatic breast cancer (KCSG-BR15-10): a multicentre, open-label, randomised, phase 2 trial. KCSG BR10-04

KCSG; KOREAN CANCER STUDY GROUP DEDICATED TO THE ADVANCEMENT OF CANCER CLINICAL TRIALS

• 850+ members from 110 hospitals and institutions in Korea • Clinical oncologists across all oncology disciplines • Highly interconnected national network for efficient global clinical trials • Well-trained healthcare professionals including CRAs, CRCs, CRPs, and members of CRO

MEMBERSHIP ORGANIZATION

654Seoul-Gyeonggi-Incheon

Gyeongsang Province

Gangwon Province

Jeolla Province

Chungcheong Province

Jeju Island

130

20

627

59

Administrative TeamQuality Assurance Committee

Board of Directors

Steering Committee

Executive Committee

Data Center

Disease Committee

Breast Cancer CommitteeProtocol Review Committee Project Management

Colorectal Cancer CommitteeInstitutional Review Board Monitoring CRAs

Inhouse CRAs

Business Development

Data Management

Regulatory Affair / Pharmacovigilance

GU/GY Cancer CommitteePlanning Committee

Lymphoma Committee

External Cooperation Committee

Stomach Cancer Committee

Translational Research Committee

Rare Cancer Committee

General Affairs

Fundraising committee

Palliative Care Committee

Public Relations Committee

Lung Cancer Committee

Education Committee Head & Neck and Esophageal Cancer Committee

Hepatobiliary & Pancreatic Cancer Committee

members

members

members

members

members

members

4 5

Page 4: Dedicated to the advancement of cancer clinical trialspositive, HER2-negative metastatic breast cancer (KCSG-BR15-10): a multicentre, open-label, randomised, phase 2 trial. KCSG BR10-04

KCSG; KOREAN CANCER STUDY GROUP DEDICATED TO THE ADVANCEMENT OF CANCER CLINICAL TRIALS

KCSG'S HISTORY

1998 Established KCSG, consisting of six committees: Stomach Cancer,

Colorectal Cancer, Lung Cancer, Head & Neck and Esophageal Cancer,

Breast Cancer, and Lymphoma

2002 Founded Hepatobiliary & Pancreatic Cancer Committee

2003 Hosted the 1st Clinical Trial Workshop

2004 Founded Palliative Care Committee

2005 Set up Institutional Review Board (IRB)

2006 Research Support Department renamed to Data Center

2007 [KCSG LU02-01] Research published: J Clin Oncol. 2007;25:5233-9

2009 Founded GU/GY cancer committee and rare cancer committee

Founded Protocol Review Committee (PRC)

Implemented KCSG-ECOG-ACRIN (Eastern Cooperative Oncology Group)

research cooperation

2010 [KCSG HB06-02] Research published: Cancer Chemother Pharmacol, 2010

Mar;65(4):641-7

2011 [KCSG ST06-04] Research published: Invest New Drugs, 2011;29:366-73

Joined ECOG as special participant member

2013 [KCSB BR07-02] Research published: J Clin Oncol. 2013;31:1732-9

2014 [KCSG LY04-03] Research published: Oncologist, 2014;19:1129-30

Entered partnership with TRIO(Translational Research in Oncology) for joint

research, received TRIO grant

Started exchange program with AGITG (Australasian Gastro-Intestinal

Trials Group)

2015 [KCSG LU05-04] Research published J Clin Oncol. 2015 Aug 20;33(24):2660-6

[KCSG GU10-17] Research published Br J Cancer. 2015;112:260-5

[KCSG HN12-02] Research published Clin Cancer Res. 2015 Feb;21(3):544-52

Participated in collaborative research with EORTC (European Organization for

Research and Treatment for Cancer)

Participated in research of CTCG (Canadian Cancer Trials Group)

2016 Endorsed by Ministry of Food and Drug Safety

2017 [KCSG LU13-08] Research published J Clin Oncol. 2017 Aug 10;35(23):2613-2618

Became a member of Breast International Group (BIG)

Established QA Committee and Translational Research Committee

2018 [KCSG PC13-09] Research published Br J Cancer. 2018 May;118(9):116901175

Hosted KCSG-KoNECT-ECRIN joint workshop

2019 Consolidated IRB Committee into PRC Committee

Hosted Clinical Trial Networking Night at ASCO 2019 (Co-host: KoNECT)

2020 [KCSG LU15-09] Research published J Clin Oncol. 2020 Feb 10;38(5):488-495

Opened online training program for cancer clinical trial professionals

6 7

Page 5: Dedicated to the advancement of cancer clinical trialspositive, HER2-negative metastatic breast cancer (KCSG-BR15-10): a multicentre, open-label, randomised, phase 2 trial. KCSG BR10-04

KCSG; KOREAN CANCER STUDY GROUP DEDICATED TO THE ADVANCEMENT OF CANCER CLINICAL TRIALS

LANDMARK TRIALS

Ther Adv Med Oncol. 2019 Aug 23;11:1-9

Real-world efficacy and safety of liposomal irinotecan plus fluorouracil/leucovorin in patients with metastatic pancreatic adenocarcinoma: a study by the Korean Cancer Study Group.

Lancet Oncol. 2014 Oct;15(11):1245-53.

Oxaliplatin, fluorouracil, and leucovorin versus fluorouracil and leucovorin as adjuvant chemotherapy for locally advanced rectal cancer after preoperative chemoradiotherapy (ADORE): an open-label, multicentre, phase 2, randomised controlled trial.

KCSG HN14-01 / Cancer. 2017 Jun 1;123(11):1958-1964.

Clinical Trial of Nintedanib in Patients With Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck:A Multicenter Phase 2 Study (Korean Cancer Study Group HN14-01)

KCSG LY16-01 / Cancer Res Treat. 2018 Apr;50(2):590-598.

Multicenter Retrospective Analysis of Clinical Characteristics, Treatment Patterns, and Outcomes in Very Elderly Patients with Diffuse Large B-Cell Lymphoma: The Korean Cancer Study Group LY16-01

KCSG GU10-16 / Eur J Cancer. 2020 Mar;127:183-190.Gemcitabine plus carboplatin versus gemcitabine plus oxaliplatin in cisplatin-unfit patients with advanced urothelial carcinoma: a randomised phase II study (COACH, KCSG GU10-16).

Hepatobiliary & Pancreatic Cancer

Colorectal Cancer

GU&GY Cancer

Head & Neck and Esophageal Cancer

KCSG PC13-09 / Br J Cancer. 2018 May;118(9):1169-1175.Predicting cumulative incidence of adverse events in older patients with cancer undergoing first-line palliative chemotherapy: Korean Cancer Study Group (KCSG) multicentre prospective study.

KCSG ST10-01 / Oncologist. 2019 Jan;24(1):18-e24.A Phase III Study to Compare the Efficacy and Safety of Paclitaxel Versus Irinotecan in Patients with Metastatic or Recurrent Gastric Cancer Who Failed in First-line Therapy (KCSG ST10-01).

KCSG BR15-10 / Lancet Oncol. 2019 Dec;20(12):1750-1759Palbociclib plus exemestane with gonadotropin-releasing hormone agonist versus capecitabine in premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer (KCSG-BR15-10): a multicentre, open-label, randomised, phase 2 trial.

KCSG BR10-04 / Eur J Cancer. 2018 Nov;103:127-136. Fulvestrant plus goserelin versus anastrozole plus goserelin versus goserelin alone for hormone receptor-positive, HER2-negative tamoxifen-pretreated premenopausal women with recurrent or metastatic breast cancer (KCSG BR10-04): a multicentre, open-label, three-arm, randomised phase II trial (FLAG study)

Lung Cancer

Lung Cancer

KCSG LU15-09 / J Clin Oncol. 2020 Feb 10;38(5):488-495. Osimertinib for Patients With Non-Small-Cell Lung Cancer Harboring Uncommon EGFR Mutations: A Multicenter, Open-Label, Phase II Trial (KCSG-LU15-09)

KCSG LU13-08 / J Clin Oncol. 2017 Aug 10;35(23):2613-2618Open-Label, Multicenter, Phase II Study of Ceritinib in Patients With Non-Small-Cell Lung Cancer Harboring ROS1 Rearrangement.

Lymphoma

Palliative Care

Stomach Cancer

Breast Cancer

Breast Cancer

8 9

Page 6: Dedicated to the advancement of cancer clinical trialspositive, HER2-negative metastatic breast cancer (KCSG-BR15-10): a multicentre, open-label, randomised, phase 2 trial. KCSG BR10-04

KCSG; KOREAN CANCER STUDY GROUP DEDICATED TO THE ADVANCEMENT OF CANCER CLINICAL TRIALS

WHAT WE DO KCSG'S CLINICAL TRIAL PROCEDURE

Research

Idea (PI)

Start

Protocol

Review

Committee

Protocol

Review

Committee

Protocol &CRF

development

from PI

Research

Completion

Disease Committee

DATA Center

PI

Clinical Trial Operation

Data Management

Stat/CSR Writing

Recruit/select

participating

institutions

Ongoing

End of follow-up

Final analysis report

Publication

Proposal

Approval

Submission

Synopsis Pre-review,

Discuss & Advise

Review,

Discuss & Advise

Approval

Admin Team

• Research support for efficient implementation of multi-

institutional clinical cancer studies

• Public relations to improve public’s understanding of clinical

cancer research

• Domestic & international cooperation programs for cancer

researchers and research institutions

• Implementation of policy studies for developing regulations

and policies on clinical cancer research

• Education programs to nurture specialized professionals in

clinical cancer research

• Scientific/academic conference for researchers

to encourage academic collaboration

10 11

Page 7: Dedicated to the advancement of cancer clinical trialspositive, HER2-negative metastatic breast cancer (KCSG-BR15-10): a multicentre, open-label, randomised, phase 2 trial. KCSG BR10-04

KCSG; KOREAN CANCER STUDY GROUP DEDICATED TO THE ADVANCEMENT OF CANCER CLINICAL TRIALS

RESEARCH ACCOMPLISHMENTS

clinical researches since 1998194

DATA CENTERis a clinical operation organization in KCSG.We provide high-quality clinical operational services to study sponsors, complying with ICH guidelines, Korean GCP and relevant regulations.

Data Management

IND/IRB Affairs

Project Management

Our Services

EDC Set Up Maintenance

Site Managementfrom initiation to close-out activities including monitoring

Professional Clinical Operation

Statistics&Medical Writing

KCSG

Achievement

Publication

9080706050403020100

2020

6

2019

15

2018

8

2017

6

2016

7

2015

7

2014

6

2013

4

2012

5

2011

2

2010

2

2009

7

2008

7

2007

2

2006

1

2005

2

36

35

12

26

1 915Colorectal Cancer

23Head & Neck and

Esophageal Cancer

11lymphoma

19Genitourinary Cancer

& Gynecologic Cancer

7Palliative Care

Stomach

Cancer

Lung Cancer

Breast Cancer

Rare Cancer Others Hepatobiliary &

Pancreatic Cancer

years of paving the way to a cancer-free world22

19443 27 13 111

Research progress

Ongoing, recruiting patients

Ongoing, but not recruiting Preparing Closed

Total

Landmark Trials

AS OF OCT 2020

12 13

Page 8: Dedicated to the advancement of cancer clinical trialspositive, HER2-negative metastatic breast cancer (KCSG-BR15-10): a multicentre, open-label, randomised, phase 2 trial. KCSG BR10-04

KCSG; KOREAN CANCER STUDY GROUP DEDICATED TO THE ADVANCEMENT OF CANCER CLINICAL TRIALS

Disease Committee

Phase Study No. Study Name

Breast Cancer

II KCSG BR17-04phase II trial of durvalumab and tremelimumab in the hormone receptor-positive, hyperMUTATed metastatic breast cancer Identified by whole exOme sequencingN (‘MUTATION1’)

Ib&II KCSG BR18-10Phase IB & II study of Ribociclib with Trastuzumab plus Letrozole in Postmenopausal HR+, HER2+ Advanced Breast Cancer Patients

II KCSG BR18-13Phase II Study of Trastuzumab plus Gedatolisib in Patients with HER-2 Positive Metastatic Breast Cancer Who Progressed after 2 or more HER-2 directed Chemotherapy

II KCSG BR18-14

Open label, multicenter, prospective phase II study to investigate the efficacy and safety of Trastuzumab biosimilar (Herzuma®) plus treatment of physician’s choice (TPC) in Patients with HER-2 Positive Metastatic Breast Cancer Who Progressed after 2 or more HER-2 directed Chemotherapy

Ib&II KCSG BR18-16A Phase IB/II, Single arm, Multi-center Study of Nivolumab in Combination with Eribulin in HER2 negative Metastatic Breast Cancer patients

II KCSG BR18-21

Randomized, Phase II Trial to Evaluate the Efficacy and Safety of Atezolizumab plus capecitabine Adjuvant Therapy compared to Capecitabine monotherapy for Triple Receptor-Negative Breast Cancer with Residual Invasive Cancer after Neoadjuvant Chemotherapy

II KCSG BR18-22Phase II trial of pembrolizumab in hormone receptor-positive, hyperMUTATted metastatic breast cancer Identified by whole exOme sequeNcing (‘MUTATION2’)

II KCSG BR19-03

Randomized, Open label, Multi-Center, Phase II Trial of Eribulin with or without SB3 (Trastuzumab-biosimilar) in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer Who Have Received at Least 2 Prior HER2-directed Regimens

NA KCSG BR19-10

Epidemiologic Evaluation and Clinical Outcomes for HER2-negative Metastatic Breast Cancer (MBC) Patients with Germline BRCA1 and 2 Pathogenic Mutation in Korea : Multi-Institutional Prospective Study to Investigate Prevalence & Clinical Outcomes

II KCSG BR19-13Single-arm Phase II Study of Palbociclib Plus Endocrine Therapy in Patients With High Risk ER-positive/HER2-negative T1-2N0-1 Early Breast Cancer Incorporating GenesWell™ BCT

III KCSG BR19-20 (TRIO033)

A phase III, multicenter, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2- negative, early breast cancer (New Adjuvant TriAl with Ribociclib [LEE011]: NATALEE)

ONGOING TRIALS AS OF OCT 2020

Breast Cancer

II KCSG BR19-21Phase II Study of Abemaciclib plus Trastuzumab biosimilar(Herzuma®) ± Fulvestrant in Patients with HER2 Positive Metastatic Breast Cancer in Brain who Progressed after HER2 directed Chemotherapy

NA KCSG BR20-01Molecular profiling using FoundationOne CDx in young (≤50 years of age) patients with metastatic breast cancer(ML41263)

II KCSG BR20-13 (TRIO038)

A randomized, multicenter, open-label, two-arm, phase ii, neoadjuvant study evaluating the efficacy, safety, and pharmacokinetics of gdc-9545 plus palbociclib compared with anastrozole plus palbociclib for postmenopausal women with estrogen receptor-positive and her2-negative untreated early breast cancer

Colorectal Cancer

NA KCSG CO15-07Pattern of use of Bevacizumab or Cetuximab in patients with metastatic colorectal cancer when added to FOLFIRI regimen as first-line treatment;multi-centre, registry study

II KCSG CO17-02

Preoperative Chemoradiotherapy with Capecitabine with or without Temozolomidein Patients with Locally Advanced Rectal Cancer; A Prospective Randomised Phase 2 Study Stratified by MGMT(O6-methylguanine DNA methyltransferase) status

II KCSG CO19-18

A randomized, open-label, multicenter phase II study of bevacizumab, infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (A-FOLFOXIRI) compared with bevacizumab, infusional fluorouracil, leucovorin, and irinotecan/oxaliplatin (AFOLFIRI/FOLFOX) as first-line treatment for metastatic right-sided colon cancer

GU&GY Cancer

III KCSG GU16-02FOur Cycles of Cisplatin-Based Chemotherapy in Metastatic Urothelial Carcinoma Compared to Six Cycles: Randomized Phase III Trial ? (FOCUS study)

III KCSG GU16-05

A Prospective Randomized Phase III Trial of Maintenance Pemetrexed versus Observation in Patients with Recurrent or Metastatic Urothelial Carcinoma who completed first line platinum-based chemotherapy without disease progression

II KCSG GU18-18An open label, single-arm, multi-center phase II study to evaluate the safety and efficacy of Herzuma® in combination with Paclitaxel in HER2-positive recurrent/metastatic urothelial carcinoma (KM-14)

NA KCSG GU20-02A Retrospective study to evaluate the comparative analysis to Axitinib versus Cabozantinib in pre-treated Patients with Advanced renal cell cancer as 2nd line treatment

II KCSG GU20-03A Multicenter Prospective Phase II Study of modified FOLFIRINOX for 1st line treatment for advanced urachus cancer

NA KCSG GU20-07Multicenter retrospective evaluation of adherence to treatment guidelines of germ cell tumor and implication of treatment outcome

14 15

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KCSG; KOREAN CANCER STUDY GROUP DEDICATED TO THE ADVANCEMENT OF CANCER CLINICAL TRIALS

Head&Neck, and

Esophageal Cancer

II KCSG HN18-07A phase II trial of neoadjuvant docetaxel/5-FU/cisplatin in combination with prophylactic Pegteograstim in unresectable, locally advanced nasal cavity/paranasal squamous cell carcinoma (SCC)

II KCSG HN19-09A randomized phase II study of consolidation pembrolizumab therapy after chemoradiotherapy in locally advanced nasopharyngeal carcinoma

III KCSG HN19-23

Randomized Phase II trial of a PD-1 inhibitor INCMGA00012 as consolidation therapy after definitive concurrent chemoradiotherapy for patients with locally advanced esophageal squamous cell carcinoma (RHAPSODY)

Hepatobiliary & Pancreatic

CancerII KCSG HB19-14

A phase II trial of trastuzumab-pkrb combined with modified FOLFOX-6 in Biliary tract cancer patients progressed on first line therapy.

Lung CancerLung

Cancer

II KCSG LU15-04Phase II trial of paclitaxel (T) vs Irinotecan(I) in patients with previously Etoposide/platinum (EP) treated, extensive disease (ED) small cell lung cancer (SCLC) as 2nd line chemotherapy

III KCSG LU15-12

Randomized phase 3 study of intercalating combination of adjuvant chemotherapy and Gefitinib versus adjuvant chemotherapy alone following complete tumor resection in non-small cell lung cancer (NSCLC) patients with common EGFR mutations

NA KCSG LU15-14Identification of Genomic Landscape of Korean Patients with Lung Cancer through Establishment of Database for Molecular Genotyping

NA KCSG LU17-13Prospective cohort and analysis of clinical outcomes of ROS1-rearranged patients with non-small-cell lung cancer

II KCSG LU17-17"The Effect of EGFR TKI Treatment Based on Liquid Biopsy Panel Screening in Patients with Non-Small Cell Lung Cancer"

III KCSG LU19-04Study of Atezolizumab in Combination with Carboplatin + Paclitaxel +Bevacizumab vs with Pemetrexed + Cisplatin or Carboplatin with Stage IV Non-Squamous Non-Small Cell Lung Cancer with EGFR(+) or ALK(+)

NA KCSG LU19-22TOAST: Totality Outcome of Afatinib Sequential Treatment in patients with EGFR sensitizing mutation-positive NSCLC in South Korea

II KCSG LU19-24Phase II study of durvalumab, doxorub icin, and ifosfamide in pulmonary sarcomatoid carcinoma

II KCSG LU19-01Randomized phase II study of pembrolizumab q 12 weeks versus q 3 weeks in NSCLC with clinical benefit to pembrolizumab monotherapy : Multicenter International Study

NA KCSG LU20-11

A retrospective multicenter study for long-term outcomes in patients with advanced and/or metastatic non-small cell lung cancer who completed two years of immune checkpoint inhibitors or who achieved durable response but discontinued due to other causes except disease progression

Lymphoma

NA KCSG LY17-08Clinical outcomes of R-miniCHOP in elderly patients older than 80 years with diffuse large B cell lymphoma: registry

II KCSG LY18-11Phase II study of rituximab plus MG4101 in patients with relapsed or refractory indolent CD20-positive non-Hodgkin lymphoma

NA KCSG LY18-01Clinical outcomes and prognostic factors in patients with advanced-stage extranodal NK/T-cell lymphoma: Korean multicenter retrospective study

NA KCSG LY20-06Multicenter retrospective analysis of clinical characteristics, treatment patterns, and outcomes in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma

Rare Cancer

NA KCSG RC20-09Clinical outcomes of Extra-mammary Paget’s disease in Korea: A multicenter, retrospective study

II KCSG UN14-13A phase II study to evaluate the efficacy of regorafenib in c-kit mutated metastatic malignant melanoma failed First-Line dacarbazine or temozolomide contained therapy.

II KCSG UN18-06Phase II Trial of Avelumab in Combination With Gemcitabine in Advanced Leiomyosarcoma as a Second-line Treatment

NA KCSG UN18-09Clinicopathologic characterization of the rare cancer in Korea: multi-center retrospective study

II KCSG UN18-15Phase II trial, Multicenter, First line Paclitaxel-Avelumab Treatment for Inoperable Angiosarcoma

Stomach Cancer

III KCSG ST14-05Phase III Study of Adjuvant Capecitabine vs Observation Alone in Curatively Resected Stage IB (by AJCC 6th Edition) Gastric Cancer

III KCSG ST15-08

A Phase 3, Open-Label, Randomized Study to Compare Adjuvant Chemotherapy of Docetaxel/Capecitabine/Oxaliplatin versus Capecitabine/Oxaliplatin in Advanced Gastric Cancer Patients at Stage IIIB and IV (M0) (Based on AJCC Ed. 6) who Received Radical Resection

III KCSG ST17-20

A multicenter, randomized, open label, phase III trial to evaluate the efficacy and safety of the combination of S-1, oxaliplatin, irinotecan in comparison to the combination of cisplatin and S-1 as first-line treatement in patients with metastatic or relapsed gastric cancer

Ib&II KCSG ST18-03Durvalumab(MEDI4736)/tremelimumab plus paclitaxel in patients with hypermutated gastric cancer who fail a first-line chemotherapy

Ib&II KCSG ST18-20Phase1b/2 study of AZD8186 in combination with paclitaxel in patients with advanced gastric cancer

NA KCSG ST20-04The Master Protocol for Cancer Genomic Screening in Patients with Advanced Gastric Cancer

All Cancer

II KCSG AL19-17A phase II Study of Tepotinib(MSC2156119J) in Patients with solid cancers harboring c-MET amplification or exon 14 mutation Who Progressed after Standard treatment for Metastatic disease

OS KCSG AL20-05Korean Precision Medicine Networking Group Study of Molecular profiling guided therapy based on genomic alterations in advanced Solid tumors (KOSMOS)

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KCSG; KOREAN CANCER STUDY GROUP DEDICATED TO THE ADVANCEMENT OF CANCER CLINICAL TRIALS

PUBLICATIONS IN 2019 - 2020 GLOBAL COOPERATIVE ACTIVITIESCooperative

GroupStudy No. Study Name

ECOG-ACRIN S1007

A Phase III, randomized clinical trial of standard adjuvant endocrine therapy +/- chemotherapy in patients with 1-3 positive nodes, hormone receptor-positive and HER2-negative breast cancer with recurrence score (RS) of 25 or less. RXPONDER: A clinical trial RX for positive node, endocrine reponsive breast cancer

TRIO TRIO 033

A phase III, multicenter, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, early breast cancer (New Adjuvant TriAL with Ribociclib [LEE011]: NATALEE).

TRIO TRIO 038

A randomized, multicenter, open label, two arm, phase II, neoadjuvant study evaluating the efficacy, safety, and pharmacokinetics of GDC 9545 plus palbociclib compared with anastrozole plus palbociclib for postmenopausal women with estrogen receptor positive and HER2-negative untreated early breast cancer

TRIO TRIO 041

A phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of regorafenib in combination with nivolumab versus transarterial chemoembolization (TACE) for the first-line treatment of intermediate-stage hepatocellular carcinoma with beyond up-to-7 criteria

BIG BIG 16-05

IMpassion030

A phase III, multicenter, randomised, open-label study comparing atezolizumab (anti PD-L1 antibody) in combination with adjuvant anthracycline/taxane-based chemotherapy versus chemotherapy alone in patients with operable triple negative breast cancer (TNBC).

BIG DECRESCENDO De-escalation of adjuvant chemotherapy in HER2-positive, estrogen receptor-negative, node-negative early breast cancer subjects who achieved pathological complete response after neoadjuvant chemotherapy and dual HER2-blockade.

EORTC 1203 GITCG Integration of trastuzumab, with or without pertuzumab, into perioperative chemotherapy of HER-2 positive gastric cancer, with multicenter validation of early PET as predictive biomarker for response

CCTG BR31 A phase III prospective double blind randomized study of adjuvant MEDI4736 in completeley resected non-small cell lung cancer NCIC CTG protocol number: BR.31

Breast Cancer CommitteeBR15-10 Lancet Oncol. 2019 Dec;20(12):1750-1759. PMID : 31668850 Palbociclib plus exemestane with gonadotropin-releasing hormone agonist versus capecitabine in premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer (KCSG-BR15-10): a multicentre, open-label, randomised, phase 2 trial.

BR11-06 Br J Cancer. 2019 Dec;121(12):985-990. PMID : 31690831 Randomised Phase 2 study of lapatinib and vinorelbine vs vinorelbine in patients with HER2 + metastatic breast cancer after lapatinib and trastuzumab treatment (KCSG BR11-16)

Int J Cancer. 2019 Sep 15;145(6):1669-1678. PMID : 30720867 Molecular alterations and poziotinib efficacy, a pan-HER inhibitor, in human epidermal growth factor receptor 2 (HER2)-positive breast cancers: Combined exploratory biomarker analysis from a phase II clinical trial of poziotinib for refractory HER2-positive breast cancer patients

BR13-11 Breast Cancer Res Treat. 2019 Nov;178(2):367-377. PMID : 31407230 Exploratory biomarker analysis from a phase II clinical trial of eribulin plus gemcitabine versus paclitaxel plus gemcitabine for HER2-negative metastatic breast cancer patients (KCSG BR13-11).

BR11-01 Cancer Res Treat. 2019 Jan;51(1):43-52. PMID : 29458237 Randomized Open Label Phase III Trial of Irinotecan Plus Capecitabine versus Capecitabine Monotherapy in Patients with Metastatic Breast Cancer Previously Treated with Anthracycline and Taxane: PROCEED Trial (KCSG BR 11-01).

BR13-11 Cancer Commun (Lond). 2019 May 28;39(1):29. PMID : 31138332 Quality of life outcomes including neuropathy-associated scale from a phase II, multicenter, randomized trial of eribulin plus gemcitabine versus paclitaxel plus gemcitabine as first-line chemotherapy for HER2-negative metastatic breast cancer: Korean Cancer Study Group Trial (KCSG BR13-11).

Colorectal Cancer Committee

CO17-07 Cancer Res Treat. 2020 Apr 24. PMID : 32340084 A Phase II Study of Avelumab Monotherapy in Patients with Mismatch Repair-Deficient/Microsatellite Instability-High or POLE-Mutated Metastatic or Unresectable Colorectal Cancer

CO12-04 Korean J Intern Med. 2019 Jan;34(1):165-177. PMID : 29172407 The impact of primary tumor location in patients with metastatic colorectal cancer: a Korean Cancer Study Group CO12-04 study

GU&GY Cancer Committee GU10-16 Eur J Cancer. 2020 Mar;127:183-190. PMID : 31668839 Gemcitabine plus carboplatin versus gemcitabine plus oxaliplatin in cisplatin-unfit patients with advanced urothelial carcinoma: a randomised phase II study (COACH, KCSG GU10-16).

GU17-03 Cancer Med. 2019 Sep;8(12):5431-5437. PMID : 31353788

Comparative effectiveness of palliative chemotherapy versus neoadjuvant chemotherapy followed by radical cystectomy versus cystectomy followed by adjuvant chemotherapy versus cystectomy for regional node-positive bladder cancer: A retrospective analysis: KCSG GU 17-03

GU11-03 Cancer Res Treat. 2019 Oct;51(4):1578-1588. PMID : 30999721 Temsirolimus in Asian Metastatic/Recurrent Non-clear Cell Renal Carcinoma

Hepatobiliary & Pancreatic Cancer Committee Ther Adv Med Oncol. 2019 Aug 23;11:1-9 PMID : 31489036 Real-world efficacy and safety of liposomal irinotecan plus fluorouracil/leucovorin in patients with metastatic pancreatic adenocarcinoma: a study by the Korean Cancer Study Group.

Lung Cancer Committee LU15-09 J Clin Oncol. 2020 Feb 10;38(5):488-495. PMID : 31825714 Osimertinib for Patients With Non-Small-Cell Lung Cancer Harboring Uncommon EGFR Mutations: A Multicenter, Open-Label, Phase II Trial (KCSG-LU15-09) LU12-13 Cancer Res Treat. 2019 Apr;51(2):718-726. PMID : 30177585 A Randomized, Open-Label, Phase II Study Comparing Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed versus Pemetrexed Alone in Patients with Epidermal Growth Factor Receptor (EGFR)-Mutant Non-small Cell Lung Cancer after Failure of First-Line EGFR Tyrosine Kinase Inhibitor: KCSG-LU12-13

Palliative Care Committee PC13-09 Oncologist. 2020 Mar;25(3):e502-e511. PMID : 32162799 Polypharmacy, Inappropriate Medication Use, and Drug Interactions in Older Korean Patients with Cancer Receiving First-Line Palliative Chemotherapy

PC14-17 Support Care Cancer. 2020 Nov;28(11):5177-5183. PMID : 32056013 Interference with daily functioning by breakthrough pain in patients with cancer

PC17-01 Cancer Res Treat. 2019 Oct;51(4):1632-1638. PMID : 30999720 Feasibility Study of Physician Orders for Life-Sustaining Treatment for Patients with Terminal Cancer

PC13-09 J Geriatr Oncol. 2019 Sep;10(5):749-756. PMID : 30952517 Serum biomarkers for predicting overall survival and early mortality in older patients with metastatic solid tumors

Stomach Cancer Committee ST10-01 Oncologist. 2019 Jan;24(1):18-e24. PMID : 30126861 A Phase III Study to Compare the Efficacy and Safety of Paclitaxel Versus Irinotecan in Patients with Metastatic or Recurrent Gastric Cancer Who Failed in First-line Therapy (KCSG ST10-01)

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