KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II
NCT ID: NCT05525858
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2022-09-28
2027-03-31
Brief Summary
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Detailed Description
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B. After site physicians confirm that NGS results of patients are available, they preliminarily decide initial treatment before MTB submission and collect informed consent form, and then patients can register to the KOSMOS-II study. Site physicians upload patients' clinical, pathologic, and genomic data for MTB submission. If site physician cannot determine initial treatment before MTB, site physician can record 'initial treatment cannot be determined' and can register the patient for MTB.
C. MTB records its treatment recommendations within available drugs list based on uploaded data, then site physicians make a final treatment decision, after informing patient about MTB decision and assessment of patients' final health status and preference.
D. Patients who have insufficient genomic information from their NGS results (e.g., lack of variant calling format file or uninterpretable reports) or who are candidates of immunotherapy will submit their tissue and/or blood, for central NGS testing and exploratory biomarker analysis.
E. Recommended treatment option There are three different options including (1) Tier 1: Therapeutic use of investigational products (KOSMOS-II drugs), (2) Tier 2: alternative treatment options, and (3) Tier 3: clinical trials
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Tier 1. Therapeutic use of investigational products (KOSMOS-II drugs)
If there are no drugs available under current regulation or patients are not feasible to any clinical trials, and If tumors have actionable genetic alterations and approved drug in any indications but tumor type is not indicative, the MTB may recommend one of KOSMOS-II drugs, therapeutic use of investigational products.
Alectinib
ALK fusion or mutations, Mutations or amplification in any of the following: RET
Atezolizumab
MSI high status by any method Or Any mutation in any of these genes:
MLH1 or MSH2 or MSH6 or PMS2 or EPCAM Or Any of the following mutations in POLE: R150X, P286R, P286H, S297F, Y298fs, F367S, V411, L424V, P436R, S459F, R665W, L698fs, R762W, R1519C, R1826W, D316H, D316G, R409W, L474P Or Any of the following mutations in POLD1: P112fs, A930fs, S478N Or Any mutation in the following: POLE not listed above, POLD1 not listed above, POLD2, POLD3, POLD4, POLQ or PRKDC Or Any loss of function mutations in BRCA1, BRCA2, ATM, MSH3, PMS1, MLH3, EXO1, RFC1, RFC2, RFC3, RFC4, RFC5, PCNA, RPA1, PRA2, PRA3, PRA4, or SSBP1 High tumor mutational burden decided by KOSMOS-II MTB (TMB ≥20/Mb in local NGS or if 10-20/Mb, confirmed by central NGS te sting)
Erlotinib
EGFR Exon 19 deletions in the region E746\_E759;
Any of the following EGFR mutations:
E709A, E709G, E709K, E884K, G719A, G719C, G719S, L858R, L861Q, L833V, S768I
Trastuzumab + Pertuzumab
ERBB2 amplification, or over-expression; or presence of any of the following ERBB2 mutations:
G309A, G309E, S310F, S310Y, R678Q, I655V, D769H, D769Y, L755S, p.L75 5\_T759del, I767M, V777L, E321G, R896C; P780ins; delL755-T759 ERBB2 amplification or approved by the KOSMOS Molecular Tumor Board
Trastuzumab emtansine
ERBB2 amplification, or over-expression; or presence of any of the following ERBB2 mutations:
G309A, G309E, S310F, S310Y, R678Q, I655V, D769H, D769Y,L755S, p.L75 5\_T759del, I767M, V777L, E321G, R896C; P780ins; delL755-T759 ERBB2 oncogenic mutations; G152V, X215\_splice, D277Y, G292C, N302K, V308M, G309A, S310F, S310Y, S244C, L651V, V659E, G660D, R678Q, V697L, G727A, T733I, L755A, L755P, L755S, D769H, D769Y, A775\_G776insSVMA, A775\_G776insYVMA (i.e.,Y772\_A775dup,M774\_A775insAYVME 770delinsEAYVM), G776\_V777 \> AVCV, G776\_V777 \> AVGCV, G776\_V777 \> VCV, G776\_V777insVC, G776C, G776delinsLCT, G776L, G776dleinsVC, G776L777\_G778insC, V777L, V777M, G778\_Y779insGSP, P780\_Y781insGSP (i.e.,G778\_P780dup), L786V, N813D, R840W, V842I, T862A, R896G, E1021Q or approved by the KOSMOS Molecular Tumor Board
Vemurafenib
BRAF\_V600E/D/K/R mutations
Bevacizumab + Erlotinib
FH inactivating mutations or approved by the KOSMOS Molecular Tumor Board
Entrectinib
ROS1 gene fusion using either a fluo rescence in situ hybridization (FISH) or next-generation sequencing (NGS) or approved by the KOSMOS Molecular Tumor Board
Pralsetinib
RET fusion or mutations; CCDC6 RET, RET V804L, RET V804M, RET M918T, KIF5B-RET, RET C634W or approved by the KOSMOS Molecular Tumor Board
Tier 2: Alternative treatments
If there are no KOSMOS-II drugs (Tier 1) or clinical trials (Tier 3) appropriate for patients, the MTB may recommend alternative treatment options (e.g., conventional therapy, radiotherapy, or supportive care).
No interventions assigned to this group
Tier 3: Clinical trial
If patient is eligible for clinical trials matched for actionable genomic alterations found in NGS testing, the MTB will recommend enrollment to clinical trials.
No interventions assigned to this group
Interventions
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Alectinib
ALK fusion or mutations, Mutations or amplification in any of the following: RET
Atezolizumab
MSI high status by any method Or Any mutation in any of these genes:
MLH1 or MSH2 or MSH6 or PMS2 or EPCAM Or Any of the following mutations in POLE: R150X, P286R, P286H, S297F, Y298fs, F367S, V411, L424V, P436R, S459F, R665W, L698fs, R762W, R1519C, R1826W, D316H, D316G, R409W, L474P Or Any of the following mutations in POLD1: P112fs, A930fs, S478N Or Any mutation in the following: POLE not listed above, POLD1 not listed above, POLD2, POLD3, POLD4, POLQ or PRKDC Or Any loss of function mutations in BRCA1, BRCA2, ATM, MSH3, PMS1, MLH3, EXO1, RFC1, RFC2, RFC3, RFC4, RFC5, PCNA, RPA1, PRA2, PRA3, PRA4, or SSBP1 High tumor mutational burden decided by KOSMOS-II MTB (TMB ≥20/Mb in local NGS or if 10-20/Mb, confirmed by central NGS te sting)
Erlotinib
EGFR Exon 19 deletions in the region E746\_E759;
Any of the following EGFR mutations:
E709A, E709G, E709K, E884K, G719A, G719C, G719S, L858R, L861Q, L833V, S768I
Trastuzumab + Pertuzumab
ERBB2 amplification, or over-expression; or presence of any of the following ERBB2 mutations:
G309A, G309E, S310F, S310Y, R678Q, I655V, D769H, D769Y, L755S, p.L75 5\_T759del, I767M, V777L, E321G, R896C; P780ins; delL755-T759 ERBB2 amplification or approved by the KOSMOS Molecular Tumor Board
Trastuzumab emtansine
ERBB2 amplification, or over-expression; or presence of any of the following ERBB2 mutations:
G309A, G309E, S310F, S310Y, R678Q, I655V, D769H, D769Y,L755S, p.L75 5\_T759del, I767M, V777L, E321G, R896C; P780ins; delL755-T759 ERBB2 oncogenic mutations; G152V, X215\_splice, D277Y, G292C, N302K, V308M, G309A, S310F, S310Y, S244C, L651V, V659E, G660D, R678Q, V697L, G727A, T733I, L755A, L755P, L755S, D769H, D769Y, A775\_G776insSVMA, A775\_G776insYVMA (i.e.,Y772\_A775dup,M774\_A775insAYVME 770delinsEAYVM), G776\_V777 \> AVCV, G776\_V777 \> AVGCV, G776\_V777 \> VCV, G776\_V777insVC, G776C, G776delinsLCT, G776L, G776dleinsVC, G776L777\_G778insC, V777L, V777M, G778\_Y779insGSP, P780\_Y781insGSP (i.e.,G778\_P780dup), L786V, N813D, R840W, V842I, T862A, R896G, E1021Q or approved by the KOSMOS Molecular Tumor Board
Vemurafenib
BRAF\_V600E/D/K/R mutations
Bevacizumab + Erlotinib
FH inactivating mutations or approved by the KOSMOS Molecular Tumor Board
Entrectinib
ROS1 gene fusion using either a fluo rescence in situ hybridization (FISH) or next-generation sequencing (NGS) or approved by the KOSMOS Molecular Tumor Board
Pralsetinib
RET fusion or mutations; CCDC6 RET, RET V804L, RET V804M, RET M918T, KIF5B-RET, RET C634W or approved by the KOSMOS Molecular Tumor Board
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically proven locally advanced or metastatic solid tumors\*\*\* who showed disease progression on standard first line anti-cancer treatment and/or has no standard treatment option
\*\*\* very rare diseases without standard treatment option which form solid mass, such as Erdheim Chester disease can be enrolled after KOSMOS MTB approval
* A genomic test results must be available in a MFDS-accredited for laboratories offering service, or in part of clinical trial/study or other commercial labs approved and certified by regulatory bodies compatible with MFDS, such as CLIA. A genomic test can be conducted with tumor tissue as well as plasma circulating tumor DNA.
1. Results from genomic profiling tests performed after diagnosis with metastatic/advanced disease to registration are acceptable. NGS results performed within three years prior to registration are preferred. Those patients with NGS results from primary tumor or more than 3 years prior to enrollment can be registered and whether NGS data is acceptable will be subject to MTB decision.
2. NGS panels should be i. Tested in a lab that is accredited by one or more quality assurance program (e.g., Korean Institute of Genomic Testing Evaluation, The Korean Society of Pathologists, Korean Society for Laboratory Medicine, Korea Laboratory Accreditation Scheme, etc.) ii. Patients who have insufficient genomic information from their NGS results (e.g., lack of variant calling format file or uninterpretable reports) or who are candidates of immunotherapy will submit their tissue and/or blood, for central NGS testing and exploratory biomarker analysis.
* Ability to understand and the willingness to sign a written informed consent document
* Life expectancy of at least 12 weeks
* Adequate recovery from most recent systemic or local treatment for cancer.
Exclusion Criteria
* Any clinical condition, according to the opinion of site physicians, which makes molecular profiling guided therapy not at the best interest of the participating patient.
* Patients who have ongoing toxicities of ≥ CTCAE 2, other than peripheral neuropathy, related to previous anti-cancer treatment. Patients with ongoing peripheral neuropathy of ≥ CTCAE 3 will be excluded. Laboratory abnormalities ≥ CTCAE 2 considered as not clinically significant by the study physician will be allowed.
* Pregnant or breastfeeding, or intending to become pregnant during the study
19 Years
ALL
No
Sponsors
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Korean Cancer Study Group
OTHER
Roche Pharma AG
INDUSTRY
Seoul National University Bundang Hospital
OTHER
Responsible Party
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Jee Hyun Kim
Professor
Principal Investigators
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JEEHYUN KIM
Role: STUDY_DIRECTOR
Seoul National University Bundang Hospital
Locations
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Soonchunhyang University Hospital Bucheon
Bucheon-si, , South Korea
Chungbuk National University Hospital
Chungju, , South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
National Cancer Center
Goyang, , South Korea
Chonnam National University Hwasun Hospital
Hwasun, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, , South Korea
Jeonbuk National University Hospital
Jeonju, , South Korea
Gyeongsang National University Hospital
Jinju, , South Korea
Dong-A University Hospital
Pusan, , South Korea
Cha University Bundang Medical Center
Seongnam, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Asan Medical Center
Seoul, , South Korea
Chung-ang University Hospital
Seoul, , South Korea
Ewha womans university Mokdong Hospital
Seoul, , South Korea
Gangbuk Samsung Hospital
Seoul, , South Korea
Hanyang University Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, , South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, , South Korea
Yonsei Cancer Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
The Catholic University of Korea, ST. Vincent's Hospital
Suwon, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Wonju Severance Christian Hospital
Wŏnju, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Jin-A Yun
Role: primary
Yae-Won Yang
Role: primary
Keon-Uk Park
Role: primary
In-Hee Lee
Role: primary
Ji-Yoon Jeong
Role: primary
So-ra Kang
Role: primary
Wonyoung Choi
Role: primary
Sang Hee Cho
Role: primary
YoungSaing Kim
Role: primary
JaeHo Byun
Role: primary
So-Yeon Jeon
Role: primary
Gyeong-Won Lee
Role: primary
Seok-Jae Huh
Role: primary
Beo-Deul Kang
Role: primary
Jee Hyun Kim
Role: primary
Min-Hee Ryu
Role: primary
Yong-Ho Noh
Role: primary
Kyung-Eun Lee
Role: primary
Dong-Hoe Koo
Role: primary
Jiwon Lee
Role: primary
Eunju Kang
Role: primary
Jin-Young Kim
Role: primary
Tae-Yong Kim
Role: primary
Se-Jun Park
Role: primary
In-Sook Woo
Role: primary
Min-Kyu Jung
Role: primary
Mi-Sun Ahn
Role: primary
Ho-Jung An
Role: primary
Hyeon-Su Im
Role: primary
Seung-Taek Lim
Role: primary
Jung-Hoon Kim
Role: primary
References
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Kim SY, Kim JH, Kim TY, Park SR, Yoon S, Lee S, Lee SH, Kim TM, Han SW, Kim HR, Yun H, Lee S, Kim J, Choi YL, Choi KS, Chae H, Ryu H, Lee GW, Zang DY, Ahn JB. Pragmatic nationwide master observational trial based on genomic alterations in advanced solid tumors: KOrean Precision Medicine Networking Group Study of MOlecular profiling guided therapy based on genomic alterations in advanced Solid tumors (KOSMOS)-II study protocol KCSG AL-22-09. BMC Cancer. 2024 May 9;24(1):574. doi: 10.1186/s12885-024-12338-y.
Other Identifiers
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KCSG AL 22-09
Identifier Type: -
Identifier Source: org_study_id
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