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    GENE:

    ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)

    i
    Other names: ROS1, ROS Proto-Oncogene 1 Receptor Tyrosine Kinase, V-Ros Avian UR2 Sarcoma Virus Oncogene Homolog 1, C-Ros Oncogene 1 Receptor Tyrosine Kinase, Proto-Oncogene Tyrosine-Protein Kinase ROS, Proto-Oncogene C-Ros-1, MCF3, ROS, V-Ros UR2 Sarcoma Virus Oncogene Homolog 1 (Avian), ROS Proto-Oncogene 1 Receptor Tyrosine Kinase, Transmembrane Tyrosine-Specific Protein Kinase, Receptor Tyrosine Kinase C-Ros Oncogene 1, C-Ros Receptor Tyrosine Kinase, Proto-oncogene C-Ros, C-Ros-1
    2d
    A Study to Learn About the Study Medicine PF-07934040 When Given Alone or With Other Anti-cancer Therapies in People With Advanced Solid Tumors That Have a Genetic Mutation. (clinicaltrials.gov)
    P1, N=330, Recruiting, Pfizer | Trial completion date: Sep 2028 --> Jan 2029 | Trial primary completion date: Sep 2027 --> Jan 2028
    Trial completion date • Trial primary completion date • IO biomarker
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    KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    KRAS mutation • KRAS G12C • KRAS G12
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    Keytruda (pembrolizumab) • Avastin (bevacizumab) • Erbitux (cetuximab) • cisplatin • carboplatin • gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • pemetrexed • oxaliplatin • leucovorin calcium • Zumrad (sasanlimab)
    3d
    UC-IMM-2511/2512: METAREM / META-1 - METAREM :Immunotherapy Master Trial for Advanced Cancers / META-1: Immunotherapy without chemotherapy for advanced lung cancer patients with high PD-L1 Levels. (2025-522655-26-00)
    P1/2, N=55, Not yet recruiting, Unicancer
    New P1/2 trial
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    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    ALK mutation
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    Keytruda (pembrolizumab) • Libtayo (cemiplimab-rwlc)
    5d
    Acquired CD74-ROS1 fusion-mediated osimertinib resistance successfully treated with osimertinib and crizotinib: a case report. (PubMed, J Chemother)
    The combination of osimertinib and crizotinib resulted in a marked clinical and metabolic response, was well tolerated, and the patient remained in remission. This rare case highlights that acquired CD74-ROS1 fusions may contribute to osimertinib resistance and suggests that combination targeted therapy may represent a potential therapeutic approach in selected patients.
    Journal
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    EGFR (Epidermal growth factor receptor) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CD74 (CD74 Molecule)
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    EGFR mutation • EGFR T790M • EGFR exon 20 insertion • ROS1 fusion • EGFR exon 20 mutation
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    Xalkori (crizotinib) • Tagrisso (osimertinib)
    5d
    Characterization and Clinical Management of Adverse Events Following Treatment with Repotrectinib: A TRIDENT-1 Analysis. (PubMed, Oncologist)
    Many repotrectinib AEs, including neurological AEs secondary to TRK inhibition, were mitigated with appropriate management, including dose modification and/or pharmacologic intervention.
    Journal • Adverse events
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    ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
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    ROS1 fusion • ROS1 positive • NTRK positive • NTRK fusion
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    Augtyro (repotrectinib)
    5d
    Ramucirumab Plus Pembrolizumab vs Usual Care for Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer Following Immunotherapy, Pragmatica-Lung Study (clinicaltrials.gov)
    P3, N=838, Active, not recruiting, SWOG Cancer Research Network | Trial primary completion date: Jan 2027 --> Nov 2025
    Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
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    BRAF mutation • HER-2 mutation • MET mutation
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    Keytruda (pembrolizumab) • Cyramza (ramucirumab)
    7d
    Zelenectide Pevedotin in NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=73, Active, not recruiting, BicycleTx Limited | Recruiting --> Active, not recruiting
    Enrollment closed
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    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • NECTIN4 (Nectin Cell Adhesion Molecule 4)
    |
    zelenectide pevedotin (BT8009)
    7d
    NAPISTAR1-01: FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC (clinicaltrials.gov)
    P1/2, N=174, Recruiting, Tubulis GmbH | N=120 --> 174
    Enrollment change • Platinum resistant • First-in-human
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    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • FOLR1 ( Folate receptor alpha ) • SLC34A2 (Solute carrier family 34 member 2) • NTRK (Neurotrophic receptor tyrosine kinase)
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    BRAF V600E • EGFR mutation • KRAS G12C • BRAF V600 • RET fusion • MET exon 14 mutation • ALK mutation • RET mutation • ROS1 fusion • MET mutation • KRAS G12 • NTRK fusion
    7d
    TROPION-Lung17: Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations (clinicaltrials.gov)
    P3, N=400, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open
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    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    KRAS G12C • MET exon 14 mutation • KRAS G12
    |
    docetaxel • Datroway (datopotamab deruxtecan-dlnk)
    7d
    Immunotherapy Biomarkers to Predict First-line PD(L)1-based Immunotherapy Response and Selection of Second-line Treatment in Stage IIIB-IV Non-small Cell Lung Cancer, IMMUNO-BIOMAP Trial (clinicaltrials.gov)
    P2, N=535, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting | Initiation date: Sep 2026 --> Apr 2026
    Enrollment open • Trial initiation date • IO biomarker
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    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    Avastin (bevacizumab) • Imfinzi (durvalumab) • Imjudo (tremelimumab-actl) • Krazati (adagrasib) • Aybintio (bevacizumab biosimilar) • Vegzelma (bevacizumab-adcd) • Avzivi (bevacizumab-tnjn)
    7d
    ADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Small Cell Lung Cancers (clinicaltrials.gov)
    P1/2, N=31, Active, not recruiting, Washington University School of Medicine | Trial completion date: Dec 2033 --> Jul 2026 | Trial primary completion date: Dec 2028 --> Jul 2026
    Trial completion date • Trial primary completion date
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    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR mutation
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    gemcitabine • docetaxel • Hepacid (pegargiminase)
    7d
    QUILT2023: Nogapendekin Alfa Inbakicept for Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=102, Terminated, ImmunityBio, Inc. | N=1538 --> 102 | Trial completion date: Dec 2026 --> Oct 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Oct 2026 --> Oct 2025; There are no longer active subjects on QUILT-2.023. Data will be entered into clinicaltrials.gov within 1 year of the primary completion date.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
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    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    PD-L1 expression • EGFR mutation • BRAF mutation • ALK translocation
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    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Avastin (bevacizumab) • cisplatin • Tecentriq (atezolizumab) • Yervoy (ipilimumab) • carboplatin • albumin-bound paclitaxel • pemetrexed • Anktiva (nogapendekin alfa inbakicept-pmln)