KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 19 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: Histologically proven locally advanced or metastatic solid tumor patients with disease progression on standard first line anti-cancer treatment and/or has no standard treatment option

Trial locations and contacts

32 sites in 1 country.

About this study

Official title: KOrean Precision Medicine Networking Group Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II

Conditions

Solid Tumor, Advanced Solid Tumor, Metastatic Cancer

Being tested

Alectinib, Atezolizumab, Erlotinib, Trastuzumab + Pertuzumab, Trastuzumab emtansine

Medical subject headings

Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• AlectinibDrug

  Also called Alecensa

  ALK fusion or mutations, Mutations or amplification in any of the following: RET

• AtezolizumabDrug

  Also called Tecentriq

  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)

• ErlotinibDrug

  Also called Tarceva

  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 + PertuzumabDrug

  Also called Herceptin + Perjeta

  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 emtansineDrug

  Also called Kadcyla

  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

• VemurafenibDrug

  Also called Zelboraf

  BRAF_V600E/D/K/R mutations

• Bevacizumab + ErlotinibDrug

  Also called Avastin + Tarceva

  FH inactivating mutations or approved by the KOSMOS Molecular Tumor Board

• EntrectinibDrug

  Also called Rozlytrek

  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

• PralsetinibDrug

  Also called Gavreto

  RET fusion or mutations; CCDC6 RET, RET V804L, RET V804M, RET M918T, KIF5B-RET, RET C634W or approved by the KOSMOS Molecular Tumor Board

What is being measured

The primary outcome is the main question the study is designed to answer.

1. To evaluate the feasibility of molecular profiling guided therapies (MGT) based on genomic alterations in patients with advanced solid tumors in terms of the proportion of receipt of the treatment

   Percentage of patients who receive molecular profiling guided therapy as recommended by MTB, either in therapeutic use of investigational products (KOSMOS-II drugs), alternative treatment, or clinical trial.

   Measured: 12 months after treatment initiation (estimated average)

2. To evaluate the effectiveness of molecular profiling guided therapies in terms of clinical benefit rate (CR/PR/SD beyond 16 +/- 2 weeks) in Tier 1* population

   Percentage of patients achieving response defined as CR/PR/SD at 16 ± 2 weeks reported by site physician

   Measured: Assessed at 16 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted2 Sep 2022
2. Study start28 Sep 2022
3. Primary completion31 Mar 2027 (estimated)
4. Study completion31 Mar 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Solid TumorStudies of the same condition, open and under way.
• More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.